Menu
FRUKDE
société des amis de Pasteur
" Jeunes gens ! Ne vous laissez pas atteindre par le scepticisme dénigrant et stérile, ne vous laissez pas décourager par les tristesses de certaines heures qui passent sur une nation ! "
  • Lipitor blood pressure

    Où rencontrer Pasteur dans Arbois

    Après les monuments dolois à l'effigie de Louis Pasteur, c'est au tour des sites arboisiens !
    Avec quelques anecdotes historiques en prime, Alain Marchal nous présente les statues, médaillons ou encore portraits qui honorent la mémoire de Louis Pasteur...

    > LIRE LA SUITE

  • [

    Lipitor cost per pill

    Mayo Clinic and Safe Health Group on Monday announced their collaboration on a new venture known Safe Health Systems, which they say can enable commodity diagnostics at a mass scale and help reduce the cost of low-complexity care processes.Launched as part of the Mayo Clinic Platform, the proprietary data platform, SAFE, can boost access to affordable treatment for common medical conditions, including COVID-19.This venture, launched as part of the Mayo Clinic Platform, "will provide the suite of apps and services that universities, employers and organizations need to restart lipitor cost per pill in-person activities and support new care models," said platform president Dr. John Halamka. HIMSS20 Digital Learn on-demand, lipitor cost per pill earn credit, find products and solutions. Get Started >>.

    The SAFE platform can help speed the deployment of custom digital health applications, enabling artificial intelligence-powered care automation and remote point of care diagnostics lipitor cost per pill. As deployed for COVID-19 testing, the technology links patients, clinicians and test providers through a smartphone app called HealthCheck. Once vaccines become available, the app can support vaccine workflow and verification.Beyond COVID-19, its initial focus is to support testing for sexually transmitted diseases, strep throat, urinary tract infections, flu, ear infection and other common conditions. Platform developers note that an absence of remote testing is a limiting factor for telehealth treatment of those and other low-complexity ailments.In an appearance at HLTH VRTL 2020 Monday, Halamka explained how the SAFE platform can help navigation of what he calls the five stages lipitor cost per pill of the pandemic.

    Isolation, testing and contact tracing, pre-vaccine return to work or return to school, vaccine distribution, and the new post-pandemic normal."What are the software systems and functionality you need in each of those transitions?. You can see that it will evolve over time," said Halamka."Imagine I woke up this morning and I have lost my sense of lipitor cost per pill taste or smell. That's concerning. If I feel that I need a certain kind of lipitor cost per pill test, it may very well be that I would reach out to a clinician.

    And the SHS app enables the easy connection of a patient with signs and symptoms to a physician who can review them and ensure the right test is ordered."That test may be an in-laboratory test. It could be an at-home gathered test or an at-home point-of-care test – all these different kinds of modalities are supported," he explained."And then, once a test result comes back, we have to take action based on signs and symptoms, based on the prevalence of infections in my community, based on my results and the accuracy of those results. Maybe I quarantine, maybe lipitor cost per pill I don't. Maybe I get additional testing.

    So that lipitor cost per pill workflow has to be supported. Mayo Clinic creates the algorithms around interpreting test results and then creating next actions."If a patient recovers and tests negative, and a workplace or school needs a "trustable validation of that test," said Halamka, the application "creates a QR code and a whole workflow that will enable a trusted back to work or back or back to school passport to appear on the phone as a result of the test."Beyond those applications, the app also incorporates software development tools for contact tracing workflow."And then we start to move into vaccines," he said. "So let's lipitor cost per pill imagine over the next year, six different vaccines will be available. They'll have different target populations, different availability, different dosing.

    You'll need to understand which vaccine is right for you and how to get it. And the app will incorporate that logic."Once you have a vaccine, [it] should generate a passport," he added lipitor cost per pill. "Given the vaccine and the timing of the vaccine, are you safe to travel?. Are you safe to return to lipitor cost per pill work?.

    Are you likely to have immunity?. And so the workflow of recording vaccines, displaying vaccines in a trustable manner, is also included in the app."Halamka called the new collaboration a good example a "joint activity between an agile software developer, Safe Health Systems, and a trusted medical institution with clinical experience and data, Mayo Clinic, working together to create an end-to-end COVID-19 solution that covers all five stages as we go through the pandemic and its resolution." Twitter. @MikeMiliardHITNEmail the writer. Mike.miliard@himssmedia.comHealthcare IT News is a HIMSS publication..

    Lipitor blood pressure

    Lipitor
    Lopid
    Caduet
    Daily dosage
    10mg
    300mg
    Can women take
    No
    Yes
    Online
    Buy with american express
    Depends on the dose
    No
    Depends on the body
    Male dosage
    40mg 60 tablet $129.95
    300mg 60 tablet $129.99
    $

    WASHINGTON, DC lipitor blood pressure – The U.S. Department of Labor’s Wage and Hour Division (WHD) today posted revisions to regulations that implemented the paid sick leave and expanded family and medical leave provisions of the Families First Coronavirus Response Act (FFCRA). The revisions made by the new rule clarify workers’ rights and employers’ responsibilities under the FFCRA’s paid leave provisions, in light of the lipitor blood pressure U.S.

    District Court for the Southern District of New York in an Aug. 3, 2020, decision that found portions of the regulations invalid. The revisions do the following lipitor blood pressure.

    Reaffirm and provide additional explanation for the requirement that employees may take FFCRA leave only if work would otherwise be available to them. Reaffirm and lipitor blood pressure provide additional explanation for the requirement that an employee have employer approval to take FFCRA leave intermittently. Revise the definition of “healthcare provider” to include only employees who meet the definition of that term under the Family and Medical Leave Act regulations or who are employed to provide diagnostic services, preventative services, treatment services or other services that are integrated with and necessary to the provision of patient care which, if not provided, would adversely impact patient care.

    Clarify that employees must provide required documentation supporting their need for FFCRA leave to their employers as soon as practicable. Correct an inconsistency lipitor blood pressure regarding when employees may be required to provide notice of a need to take expanded family and medical leave to their employers.“As the economy continues to rebound, more businesses return to full capacity, and schools reopen, the need for clarity regarding the Families First Coronavirus Response Act paid leave provisions may be greater than ever,” said Wage and Hour Administrator Cheryl Stanton. €œToday’s updates respond to this evolving situation and address some of the challenges the American workforce faces.

    Our continuing robust response to this pandemic balances support for workers and employers alike, and remains our priority.” The Department lipitor blood pressure issued its initial temporary rule implementing provisions under the FFCRA on April 1, 2020. Read the revisions to that temporary rule, which will become effective Sept. 16, 2020 in the Federal Register.

    The FFCRA helps lipitor blood pressure the U.S. Combat and defeat the workplace effects of the coronavirus by giving tax credits to American businesses with fewer than 500 employees to provide employees with paid leave for certain reasons related to the coronavirus. Please visit WHD’s “Quick Benefits Tips” for information about how much leave workers may qualify to use, and the wages lipitor blood pressure employers must pay.

    The law enables employers to provide paid leave reimbursed by tax credits, while at the same time ensuring that workers are not forced to choose between their paychecks and the public health measures needed to combat the virus. WHD continues to provide updated information on its website and through extensive outreach efforts to ensure that workers and employers have the information they need about the benefits and protections of the FFCRA. The agency also provides additional information on common issues employers and employees face when responding to the coronavirus and its effects on wages and hours worked under the Fair Labor Standards Act lipitor blood pressure and on job-protected leave under the Family and Medical Leave Act at https://www.dol.gov/agencies/whd/pandemic.

    WHD’s mission is to promote and achieve compliance with labor standards to protect and enhance the welfare of the nation’s workforce. WHD enforces federal lipitor blood pressure minimum wage, overtime pay, recordkeeping, and child labor requirements of the FLSA. WHD also enforces the paid sick leave and expanded family and medical leave requirements of the Families First Coronavirus Response Act, the Migrant and Seasonal Agricultural Worker Protection Act, the Employee Polygraph Protection Act, the Family and Medical Leave Act, wage garnishment provisions of the Consumer Credit Protection Act, and a number of employment standards and worker protections as provided in several immigration related statutes.

    Additionally, WHD administers and enforces the prevailing wage requirements of the Davis Bacon Act and the Service Contract Act and other statutes applicable to Federal contracts for construction and for the provision of goods and services. The mission lipitor blood pressure of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States. Improve working conditions.

    Advance opportunities for profitable lipitor blood pressure employment. And assure work-related benefits and rights.PARAMUS, NJ – The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has cited CarePlus Bergen Inc., doing business as Bergen New Bridge Medical Center, for violating respiratory protection standards at its Paramus, New Jersey, location.

    OSHA cited the hospital for two serious violations, with proposed penalties of $9,639.Based on a coronavirus-related inspection, OSHA cited the Bergen New Bridge Medical Center for lipitor blood pressure failing to fit test tight-fitting face piece respirators on employees who were required to use them. The hospital also failed to train employees on proper respirator use and ensure employees understood when to wear a respirator. “Employers must lipitor blood pressure take action to protect their employees during the pandemic, including implementing effective respiratory protection programs,” said OSHA Hasbrouck Heights Area Office Director Lisa Levy.

    €œOSHA standards require healthcare workers to be fit-tested to ensure the respirators they use provide adequate protection.” Employers with questions on compliance with OSHA standards should contact their local OSHA office for guidance and assistance at 800-321-OSHA (6742). OSHA’s COVID-19 response webpage offers extensive resources for addressing safety and health hazards during the evolving coronavirus pandemic. The company has 15 business days from receipt of the citations and penalties lipitor blood pressure to comply, request an informal conference with OSHA’s area director or contest the findings before the independent Occupational Safety and Health Review Commission.

    Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to lipitor blood pressure help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit http://www.osha.gov.

    The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States. Improve working lipitor blood pressure conditions. Advance opportunities for profitable employment.

    And assure work-related benefits and rights..

    WASHINGTON, DC lipitor cost per pill – The U.S. Department of Labor’s Wage and Hour Division (WHD) today posted revisions to regulations that implemented the paid sick leave and expanded family and medical leave provisions of the Families First Coronavirus Response Act (FFCRA). The revisions made by the lipitor cost per pill new rule clarify workers’ rights and employers’ responsibilities under the FFCRA’s paid leave provisions, in light of the U.S. District Court for the Southern District of New York in an Aug. 3, 2020, decision that found portions of the regulations invalid.

    The revisions do the lipitor cost per pill following. Reaffirm and provide additional explanation for the requirement that employees may take FFCRA leave only if work would otherwise be available to them. Reaffirm and provide additional explanation for the requirement that an employee have employer approval to take lipitor cost per pill FFCRA leave intermittently. Revise the definition of “healthcare provider” to include only employees who meet the definition of that term under the Family and Medical Leave Act regulations or who are employed to provide diagnostic services, preventative services, treatment services or other services that are integrated with and necessary to the provision of patient care which, if not provided, would adversely impact patient care. Clarify that employees must provide required documentation supporting their need for FFCRA leave to their employers as soon as practicable.

    Correct an inconsistency regarding when employees may be required to provide notice of a need to take expanded family and medical leave to their employers.“As the economy continues to rebound, more lipitor cost per pill businesses return to full capacity, and schools reopen, the need for clarity regarding the Families First Coronavirus Response Act paid leave provisions may be greater than ever,” said Wage and Hour Administrator Cheryl Stanton. €œToday’s updates respond to this evolving situation and address some of the challenges the American workforce faces. Our continuing robust response to this pandemic balances support for workers and employers alike, and remains our priority.” The Department issued its initial lipitor cost per pill temporary rule implementing provisions under the FFCRA on April 1, 2020. Read the revisions to that temporary rule, which will become effective Sept. 16, 2020 in the Federal Register.

    The FFCRA helps the U.S lipitor cost per pill. Combat and defeat the workplace effects of the coronavirus by giving tax credits to American businesses with fewer than 500 employees to provide employees with paid leave for certain reasons related to the coronavirus. Please visit WHD’s “Quick Benefits Tips” lipitor cost per pill for information about how much leave workers may qualify to use, and the wages employers must pay. The law enables employers to provide paid leave reimbursed by tax credits, while at the same time ensuring that workers are not forced to choose between their paychecks and the public health measures needed to combat the virus. WHD continues to provide updated information on its website and through extensive outreach efforts to ensure that workers and employers have the information they need about the benefits and protections of the FFCRA.

    The agency also provides additional information on common issues employers and employees face lipitor cost per pill when responding to the coronavirus and its effects on wages and hours worked under the Fair Labor Standards Act and on job-protected leave under the Family and Medical Leave Act at https://www.dol.gov/agencies/whd/pandemic. WHD’s mission is to promote and achieve compliance with labor standards to protect and enhance the welfare of the nation’s workforce. WHD enforces federal minimum wage, overtime pay, recordkeeping, and child labor requirements of the FLSA lipitor cost per pill. WHD also enforces the paid sick leave and expanded family and medical leave requirements of the Families First Coronavirus Response Act, the Migrant and Seasonal Agricultural Worker Protection Act, the Employee Polygraph Protection Act, the Family and Medical Leave Act, wage garnishment provisions of the Consumer Credit Protection Act, and a number of employment standards and worker protections as provided in several immigration related statutes. Additionally, WHD administers and enforces the prevailing wage requirements of the Davis Bacon Act and the Service Contract Act and other statutes applicable to Federal contracts for construction and for the provision of goods and services.

    The mission of the Department of Labor is to foster, promote and develop the welfare of lipitor cost per pill the wage earners, job seekers and retirees of the United States. Improve working conditions. Advance opportunities for lipitor cost per pill profitable employment. And assure work-related benefits and rights.PARAMUS, NJ – The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has cited CarePlus Bergen Inc., doing business as Bergen New Bridge Medical Center, for violating respiratory protection standards at its Paramus, New Jersey, location.

    OSHA cited lipitor cost per pill the hospital for two serious violations, with proposed penalties of $9,639.Based on a coronavirus-related inspection, OSHA cited the Bergen New Bridge Medical Center for failing to fit test tight-fitting face piece respirators on employees who were required to use them. The hospital also failed to train employees on proper respirator use and ensure employees understood when to wear a respirator. “Employers must take lipitor cost per pill action to protect their employees during the pandemic, including implementing effective respiratory protection programs,” said OSHA Hasbrouck Heights Area Office Director Lisa Levy. €œOSHA standards require healthcare workers to be fit-tested to ensure the respirators they use provide adequate protection.” Employers with questions on compliance with OSHA standards should contact their local OSHA office for guidance and assistance at 800-321-OSHA (6742). OSHA’s COVID-19 response webpage offers extensive resources for addressing safety and health hazards during the evolving coronavirus pandemic.

    The company has 15 business days from receipt of the citations and lipitor cost per pill penalties to comply, request an informal conference with OSHA’s area director or contest the findings before the independent Occupational Safety and Health Review Commission. Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is lipitor cost per pill to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit http://www.osha.gov. The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States.

    Improve working conditions lipitor cost per pill. Advance opportunities for profitable employment. And assure work-related benefits and rights..

    What side effects may I notice from Lipitor?

    Side effects that you should report to your doctor or health care professional as soon as possible:

    • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
    • dark urine
    • fever
    • joint pain
    • muscle cramps, pain
    • redness, blistering, peeling or loosening of the skin, including inside the mouth
    • trouble passing urine or change in the amount of urine
    • unusually weak or tired
    • yellowing of eyes or skin

    Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

    • constipation
    • heartburn
    • stomach gas, pain, upset

    This list may not describe all possible side effects.

    Lipitor medicine

    In her opening statement before the Senate Judiciary Committee last week, Judge Amy Coney Barrett, President Trump's nominee to the Supreme Court, opined that courts are not policymakers.This should not be surprising -- after all, she has also said that the courts' obligation is not to decide what legislators meant in the words used to write lipitor medicine laws, only to seek out their clarity. Barrett also criticized Supreme Court Chief Justice John Roberts' majority opinion in a 2012 case upholding the Affordable Care Act (ACA), saying that he failed to follow the clear language of the statute when he decided that the fine imposed under the law for not purchasing health insurance was a "tax" allowed under Congress' taxing authority and not a penalty disallowed by the Commerce Clause.In fact, Trump is before the Supreme Court right now, with a case being argued before the justices on Nov. 10 arguing that all lipitor medicine of Obamacare is unconstitutional. Pundits have rightfully conjectured that he chose Barrett to do his bidding and vote to strike down the law.

    As Barrett's confirmation hearing lipitor medicine began last week, Trump tweeted:"We will have Healthcare which is FAR BETTER than ObamaCare, at a FAR LOWER COST – big premium REDUCTION, PEOPLE WITH PRE EXISTING CONDITIONS WILL BE PROTECTED AT AN EVEN HIGHER LEVEL THAN NOW. HIGHLY UNPOPULAR AND UNFAIR INDIVIDUAL MANDATE ALREADY TERMINATED. YOU'RE WELCOME! lipitor medicine. "He has delivered such a message throughout his presidency, in this year alone starting with his State of the Union address, declaring support for Americans with pre-existing conditions and promising every so often that he will be introducing a spanking new healthcare plan to replace the ACA.

    Nothing has come forth, lipitor medicine nor will it. It's pure bluster and deceit.Trump's Last Chance -- Possibly -- to Destroy the ACABut a struggle now comes to bear between Barrett's views on what courts are limited in doing, and Trump wanting her to be his messenger. Trump knows this may be his last chance to destroy Obama's most lipitor medicine prizeworthy legislative achievement, one that has survived 70 attempts by Republicans in Congress to kill it. Indeed, Democrats are characterizing Barrett's nomination as an attack on Americans' right to healthcare.Barrett told committee members that her prior published views disagreeing with the Supreme Court's two decisions upholding Obamacare (in another case in 2015, the Supreme Court also found the ACA constitutional) have no bearing on her thinking, because the case before the court in November deals with a different issue.

    Whether the individual mandate, if it's unconstitutional, can be easily severed from the rest of the 974-page law lipitor medicine. That reasoning is questionable because before the court can address severability, it must first decide whether the mandate is constitutional.She concurs that severing an unconstitutional provision from the rest of a statute is always a judge's "presumption" and stressed, "I am not here on a mission to destroy the Affordable Care Act. I'm here to apply the law and adhere to the rule of law." She also gave no commitments to the White House on how she would rule. (A more complete analysis of the options for what the Supreme Court may do with Barrett on the bench is covered here.)Despite Barrett's protestations to the contrary, it's unclear how unbiased she might be if she does get on the high court -- remember that Trump chose her lipitor medicine.

    A more fundamental question lurks. Regardless of how cases are decided, is it ethical to take away a law lipitor medicine that has become a legislative embodiment of what many now consider to be their lifeline -- their right -- to healthcare?. The History of the Right to HealthcareBack in 2008 while Obama was on the campaign trail running against the late Sen. John McCain (R-Ariz.), lipitor medicine he called healthcare a right -- not a privilege or a responsibility.

    That position has become the description du jour this election cycle by many running for office, but they were not the first. Various forms for providing healthcare besides the ACA have been floated since, from a Medicare-for-All system, to reducing the age lipitor medicine to become Medicare-eligible, to amending ACA with a public option, the latter supported by Biden. Opponents of government-run healthcare rail against government interference in their lives and call such systems "socialism," even as they hold tightly to their Medicare cards. And consider who paid for Trump's recent COVID-19 lipitor medicine hospital and medical care at Walter Reed.

    It surely wasn't a private insurer.The idea of healthcare as a right has been around for decades, tracing its roots back to FDR in 1943 when he crafted his proposed "Second Bill of Rights." As more fully explained by authors Jean Carmalt and Sarah Zaidi, FDR declared "freedom from want" to be four essential liberties for human security, including "the right to adequate medical care and the opportunity to achieve and enjoy good health." Carmalt and Zaidi wrote, "The right to health was subsequently enshrined in the Universal Declaration of Human Rights, a 1948 United Nations document." We can even go back to the Declaration of Independence for our inalienable rights to life, liberty, and the pursuit of happiness as words connoting an ability to achieve, maintain, and regain our health.Of course, there is no "right" to healthcare in the Constitution. Instead, it is considered a moral imperative, a human right -- at least, that's how every other industrialized country views it except lipitor medicine for the U.S., where it's considered a profit-making opportunity. True, other facets of life might also be considered "rights" -- equal treatment for LGBTQ persons, fair housing, civil rights, and the right to vote. And while each of those is surely a noble cause, healthcare is the only one that affects every one of us from birth to death (including the "right to die" for those terminally ill with a painful disease).Ethical Questions to PonderThe judiciary committee expects to approve Barrett's nomination along party lines later this week, and full Senate approval is expected soon thereafter.

    In the meantime, her nomination has become a symbol for assaulting the ACA, a law that's a prime example of the right to lipitor medicine healthcare.This assault on the healthcare law raises many ethical questions. Is it ethical, for example, to decide a seminal law in a way that allows destruction of a moral imperative that millions of Americans have counted on for a decade to preserve and protect health?. That includes those enrolled in its Medicaid expansion programs, children who are now allowed to remain on lipitor medicine their parents' policies until age 26, and anyone benefitting from the law's ban on annual or lifetime coverage caps. Not to mention the more than 8 million people infected with COVID-19 who will benefit from the ACA's ban on insurer discrimination against people with preexisting conditions.The justices will have to decide the ACA case using analyses within a legal framework and employing various legal doctrines, notably severability.

    But another dilemma, also of some ethical lipitor medicine proportion, awaits their particular analysis. If they find the entire act unconstitutional, there is currently nothing with which to replace it, nor is a replacement likely to appear any time soon. The court may have to decide the case, but it can't simply throw Obamacare under the bus even lipitor medicine as the justices know their newest member was chosen through a process that some are calling a sham. Barrett's nomination has proceeded at warp speed while an election is ongoing, with millions of votes for the next president already cast.Not since the days of Abraham Lincoln -- in which a vacancy occurred 27 days before a presidential election -- has a justice been chosen in such haste and with utter disregard for what the people want.

    (Lincoln, unlike Trump, waited until immediately after the election to nominate a replacement -- both because the Senate wasn't in session when the vacancy occurred, and because he could use the opening to his advantage during the campaign.) Even Barrett's colleagues lipitor medicine at the University of Notre Dame, in an open letter, are calling on her to put the country ahead of the rush to get her confirmed.Whether she likes it or not, Amy Coney Barrett has become the poster child for whether or not the ACA will remain the sine qua non of healthcare as a right for all.Miles J. Zaremski, JD, has been a healthcare attorney and writer for 47 years. He has written and lectured lipitor medicine extensively in the healthcare law space, both nationally and abroad. He has written books and also contributed essays to the Huffington Post and to CNN's Michael Smerconish site.

    He is past president of the American College of Legal Medicine and for 5 years served as chair of the American Bar Association's Standing Committee on Medical Professional Liability..

    In her opening statement before the Senate Judiciary Committee last week, Judge Amy Coney Barrett, President Trump's lipitor cost per pill nominee to the Supreme Court, opined that courts are not policymakers.This should not be surprising -- after all, she has also said that the courts' obligation is not to decide what legislators meant in the words used to write laws, only to seek out their clarity. Barrett also criticized Supreme Court Chief Justice John Roberts' majority opinion in a 2012 case upholding the Affordable Care Act (ACA), saying that he failed to follow the clear language of the statute when he decided that the fine imposed under the law for not purchasing health insurance was a "tax" allowed under Congress' taxing authority and not a penalty disallowed by the Commerce Clause.In fact, Trump is before the Supreme Court right now, with a case being argued before the justices on Nov. 10 arguing that all of Obamacare is unconstitutional lipitor cost per pill. Pundits have rightfully conjectured that he chose Barrett to do his bidding and vote to strike down the law. As Barrett's confirmation hearing began last week, Trump tweeted:"We will have Healthcare lipitor cost per pill which is FAR BETTER than ObamaCare, at a FAR LOWER COST – big premium REDUCTION, PEOPLE WITH PRE EXISTING CONDITIONS WILL BE PROTECTED AT AN EVEN HIGHER LEVEL THAN NOW.

    HIGHLY UNPOPULAR AND UNFAIR INDIVIDUAL MANDATE ALREADY TERMINATED. YOU'RE WELCOME! lipitor cost per pill. "He has delivered such a message throughout his presidency, in this year alone starting with his State of the Union address, declaring support for Americans with pre-existing conditions and promising every so often that he will be introducing a spanking new healthcare plan to replace the ACA. Nothing has lipitor cost per pill come forth, nor will it. It's pure bluster and deceit.Trump's Last Chance -- Possibly -- to Destroy the ACABut a struggle now comes to bear between Barrett's views on what courts are limited in doing, and Trump wanting her to be his messenger.

    Trump knows this may be his last chance to destroy Obama's most prizeworthy lipitor cost per pill legislative achievement, one that has survived 70 attempts by Republicans in Congress to kill it. Indeed, Democrats are characterizing Barrett's nomination as an attack on Americans' right to healthcare.Barrett told committee members that her prior published views disagreeing with the Supreme Court's two decisions upholding Obamacare (in another case in 2015, the Supreme Court also found the ACA constitutional) have no bearing on her thinking, because the case before the court in November deals with a different issue. Whether the individual mandate, if it's unconstitutional, can be easily severed from the rest lipitor cost per pill of the 974-page law. That reasoning is questionable because before the court can address severability, it must first decide whether the mandate is constitutional.She concurs that severing an unconstitutional provision from the rest of a statute is always a judge's "presumption" and stressed, "I am not here on a mission to destroy the Affordable Care Act. I'm here to apply the law and adhere to the rule of law." She also gave no commitments to the White House on how she would rule.

    (A more complete analysis of the options for what the Supreme Court may do with Barrett on the bench is covered here.)Despite lipitor cost per pill Barrett's protestations to the contrary, it's unclear how unbiased she might be if she does get on the high court -- remember that Trump chose her. A more fundamental question lurks. Regardless of how cases are decided, is it lipitor cost per pill ethical to take away a law that has become a legislative embodiment of what many now consider to be their lifeline -- their right -- to healthcare?. The History of the Right to HealthcareBack in 2008 while Obama was on the campaign trail running against the late Sen. John McCain (R-Ariz.), he called healthcare a right -- not a lipitor cost per pill privilege or a responsibility.

    That position has become the description du jour this election cycle by many running for office, but they were not the first. Various forms for providing healthcare besides the ACA have been floated since, from a Medicare-for-All system, to reducing the age to become Medicare-eligible, to amending ACA with a public option, the latter supported lipitor cost per pill by Biden. Opponents of government-run healthcare rail against government interference in their lives and call such systems "socialism," even as they hold tightly to their Medicare cards. And consider who paid for Trump's recent COVID-19 hospital and lipitor cost per pill medical care at Walter Reed. It surely wasn't a private insurer.The idea of healthcare as a right has been around for decades, tracing its roots back to FDR in 1943 when he crafted his proposed "Second Bill of Rights." As more fully explained by authors Jean Carmalt and Sarah Zaidi, FDR declared "freedom from want" to be four essential liberties for human security, including "the right to adequate medical care and the opportunity to achieve and enjoy good health." Carmalt and Zaidi wrote, "The right to health was subsequently enshrined in the Universal Declaration of Human Rights, a 1948 United Nations document." We can even go back to the Declaration of Independence for our inalienable rights to life, liberty, and the pursuit of happiness as words connoting an ability to achieve, maintain, and regain our health.Of course, there is no "right" to healthcare in the Constitution.

    Instead, it is considered a moral imperative, a human right -- at least, that's how every other industrialized country views it except for the U.S., where it's considered a profit-making opportunity lipitor cost per pill. True, other facets of life might also be considered "rights" -- equal treatment for LGBTQ persons, fair housing, civil rights, and the right to vote. And while each of those is surely a noble cause, healthcare is the only one that affects every one of us from birth to death (including the "right to die" for those terminally ill with a painful disease).Ethical Questions to PonderThe judiciary committee expects to approve Barrett's nomination along party lines later this week, and full Senate approval is expected soon thereafter. In the meantime, her nomination has lipitor cost per pill become a symbol for assaulting the ACA, a law that's a prime example of the right to healthcare.This assault on the healthcare law raises many ethical questions. Is it ethical, for example, to decide a seminal law in a way that allows destruction of a moral imperative that millions of Americans have counted on for a decade to preserve and protect health?.

    That includes those enrolled in its Medicaid expansion programs, children who are now allowed to remain on lipitor cost per pill their parents' policies until age 26, and anyone benefitting from the law's ban on annual or lifetime coverage caps. Not to mention the more than 8 million people infected with COVID-19 who will benefit from the ACA's ban on insurer discrimination against people with preexisting conditions.The justices will have to decide the ACA case using analyses within a legal framework and employing various legal doctrines, notably severability. But another lipitor cost per pill dilemma, also of some ethical proportion, awaits their particular analysis. If they find the entire act unconstitutional, there is currently nothing with which to replace it, nor is a replacement likely to appear any time soon. The court may have to decide the case, but it can't simply throw Obamacare under the bus even as the justices know their newest member was chosen through a process lipitor cost per pill that some are calling a sham.

    Barrett's nomination has proceeded at warp speed while an election is ongoing, with millions of votes for the next president already cast.Not since the days of Abraham Lincoln -- in which a vacancy occurred 27 days before a presidential election -- has a justice been chosen in such haste and with utter disregard for what the people want. (Lincoln, unlike Trump, waited until immediately after the election to nominate a replacement -- both because the Senate wasn't in session when the vacancy occurred, and because he could use the opening to his advantage during the campaign.) Even Barrett's colleagues at the University of Notre Dame, in an open letter, are calling on lipitor cost per pill her to put the country ahead of the rush to get her confirmed.Whether she likes it or not, Amy Coney Barrett has become the poster child for whether or not the ACA will remain the sine qua non of healthcare as a right for all.Miles J. Zaremski, JD, has been a healthcare attorney and writer for 47 years. He has written and lectured extensively in the healthcare law space, both lipitor cost per pill nationally and abroad. He has written books and also contributed essays to the Huffington Post and to CNN's Michael Smerconish site.

    He is past president of the American College of Legal Medicine and for 5 years served as chair of the American Bar Association's Standing Committee on Medical Professional Liability..

    Is lipitor bad for your liver

    Trial Population is lipitor bad for your liver Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 is lipitor bad for your liver Trial at Enrollment. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1).

    Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.

    Figure 1. Figure 1. Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

    Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

    Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2. Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens.

    Figure 2. Figure 2. SARS-CoV-2 Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

    Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively.

    Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

    The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

    The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]. Figure 2C, Fig. S8, and Table 2.

    80% inhibitory dilution [ID80]. Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43.

    The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

    Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >.

    Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Patients Figure 1. Figure 1. Enrollment and Randomization.

    Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned.

    Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group).

    Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1. Table 1. Demographic and Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

    On the basis of the evolving epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12).

    Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2.

    Figure 2. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

    Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2. Table 2. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population.

    Figure 3. Figure 3. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients.

    Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32. 95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

    Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant.

    An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients). Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe.

    Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81. 380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

    P=0.001. 844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

    1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3).

    4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

    The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]).

    Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Announced on May 15, Operation Warp Speed (OWS) — a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector — aims to accelerate control of the Covid-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S. Government typically supports product development and vaccine distribution. The initiative was premised on setting a “stretch goal” — one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for Covid-19 countermeasure research and development across the U.S. Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR).

    One of us (M.S.) serves as OWS chief advisor. We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a SARS-CoV-2 vaccine — with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S. Population — beginning at the end of 2020 and to have as many as 300 million doses of such vaccines available and deployed by mid-2021.

    The pace and scope of such a vaccine effort are unprecedented. The 2014 West African Ebola virus epidemic spurred rapid vaccine development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. SARS-CoV-2 vaccine development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July. Our objectives are based on advances in vaccine platform technology, improved understanding of safe and efficacious vaccine design, and similarities between the SARS-CoV-1 and SARS-CoV-2 disease mechanisms.OWS’s role is to enable, accelerate, harmonize, and advise the companies developing the selected vaccines.

    The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder vaccine development or deployment.OWS selected vaccine candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy. Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the virus, to deliver efficacy outcomes by the end of 2020 or the first half of 2021. Candidates had to be based on vaccine-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021.

    Finally, candidates had to use one of four vaccine-platform technologies that we believe are the most likely to yield a safe and effective vaccine against Covid-19. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWS’s strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two vaccine candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best vaccine platform for each subpopulation at risk for contracting or transmitting Covid-19, including older adults, frontline and essential workers, young adults, and pediatric populations. In addition, advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate vaccine program development without compromising safety, efficacy, or product quality.

    Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel. Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate vaccine.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA. To permit appropriate comparisons among the vaccine candidates and to optimize vaccine utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the Coronavirus Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their vaccines are in preclinical or very early clinical stages.

    To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each vaccine candidate. We aim to have stockpiled, at OWS’s expense, a few tens of millions of vaccine doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate vaccine development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each vaccine for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit vaccine administration before all BLA procedures are completed.Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies. Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein).

    These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA vaccine in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTech’s RNA vaccine also produced encouraging phase 1 results2 and started its phase 3 trial on July 27. The ChAdOx replication-defective live-vector vaccine developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S. Phase 3 trials in August.3 The Janssen Ad26 Covid-19 replication-defective live-vector vaccine has demonstrated excellent protection in nonhuman primate models and began its U.S.

    Phase 1 trial on July 27. It should be in phase 3 trials in mid-September. Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein vaccine in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by year’s end.5On the process-development front, the RNA vaccines are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHS–DOD partnership is laying the groundwork for vaccine distribution, subpopulation prioritization, financing, and logistic support. We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues.

    We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive vaccine doses once they are ready. Prioritization will also depend on the relative performance of each vaccine and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo. Participants had known exposure (by participant report) to a person with laboratory-confirmed Covid-19, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure.

    The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for SARS-CoV-2, with the eligibility window extended to within 4 days after exposure. This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application. In Canada, the trial was approved by Health Canada.

    Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org). Persons with symptoms of Covid-19 or with PCR-proven SARS-CoV-2 infection were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early infection. Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms.

    Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed. Participants provided a digitally captured signature to indicate informed consent. We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations.

    Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes. When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participant’s illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status. Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country.

    A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence. Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier. The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total).

    If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the SARS-CoV-2 in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased. Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, Covid-19–related symptoms. We assumed that health care workers would have access to Covid-19 testing if symptomatic.

    However, access to testing was limited throughout the trial period. Covid-19–related symptoms were based on U.S. Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for SARS-Cov-2 on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria. Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for Covid-19 or death, the incidence of PCR-confirmed SARS-CoV-2 infection, the incidence of Covid-19 symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text.

    Outcome data were measured within 14 days after trial enrollment. Outcome data including PCR testing results, possible Covid-19–related symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org. Sample Size We anticipated that illness compatible with Covid-19 would develop in 10% of close contacts exposed to Covid-19.9 Using Fisher’s exact method with a 50% relative effect size to reduce new symptomatic infections, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group.

    We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic Covid-19 after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new infections in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic infections. Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up. Stopping guidelines were provided to the data and safety monitoring board with the use of a Lan–DeMets spending function analogue of the O’Brien–Fleming boundaries for the primary outcome.

    A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of infections in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue. Statistical Analysis We assessed the incidence of Covid-19 disease by day 14 with Fisher’s exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisher’s exact test.

    Among participants in whom incident illness compatible with Covid-19 developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a Kruskal–Wallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05. For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event. Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

    (Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible.

    Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee.

    The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

    For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

    Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death.

    Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

    Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio.

    Table 1. Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

    This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

    Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford..

    Trial Population lipitor cost per pill Table 1. Table 1. Characteristics of the Participants in the mRNA-1273 Trial at Enrollment lipitor cost per pill. The 45 enrolled participants received their first vaccination between March 16 and April 14, 2020 (Fig. S1).

    Three participants did not receive the second vaccination, including one in the 25-μg group who had urticaria on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits. The demographic characteristics of participants at enrollment are provided in Table 1. Vaccine Safety No serious adverse events were noted, and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.

    Figure 1. Figure 1. Systemic and Local Adverse Events. The severity of solicited adverse events was graded as mild, moderate, or severe (see Table S1).After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group. All were mild or moderate in severity (Figure 1 and Table S2).

    Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events. None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever. One of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe. (Additional details regarding adverse events for that participant are provided in the Supplementary Appendix.) Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common.

    Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Evaluation of safety clinical laboratory values of grade 2 or higher and unsolicited adverse events revealed no patterns of concern (Supplementary Appendix and Table S3). SARS-CoV-2 Binding Antibody Responses Table 2. Table 2. Geometric Mean Humoral Immunogenicity Assay Responses to mRNA-1273 in Participants and in Convalescent Serum Specimens.

    Figure 2. Figure 2. SARS-CoV-2 Antibody and Neutralization Responses. Shown are geometric mean reciprocal end-point enzyme-linked immunosorbent assay (ELISA) IgG titers to S-2P (Panel A) and receptor-binding domain (Panel B), PsVNA ID50 responses (Panel C), and live virus PRNT80 responses (Panel D). In Panel A and Panel B, boxes and horizontal bars denote interquartile range (IQR) and median area under the curve (AUC), respectively.

    Whisker endpoints are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. The convalescent serum panel includes specimens from 41 participants. Red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent serum panel. In Panel C, boxes and horizontal bars denote IQR and median ID50, respectively.

    Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR. In the convalescent serum panel, red dots indicate the 3 specimens that were also tested in the PRNT assay. The other 38 specimens were used to calculate summary statistics for the box plot in the convalescent panel. In Panel D, boxes and horizontal bars denote IQR and median PRNT80, respectively. Whisker end points are equal to the maximum and minimum values below or above the median ±1.5 times the IQR.

    The three convalescent serum specimens were also tested in ELISA and PsVNA assays. Because of the time-intensive nature of the PRNT assay, for this preliminary report, PRNT results were available only for the 25-μg and 100-μg dose groups.Binding antibody IgG geometric mean titers (GMTs) to S-2P increased rapidly after the first vaccination, with seroconversion in all participants by day 15 (Table 2 and Figure 2A). Dose-dependent responses to the first and second vaccinations were evident. Receptor-binding domain–specific antibody responses were similar in pattern and magnitude (Figure 2B). For both assays, the median magnitude of antibody responses after the first vaccination in the 100-μg and 250-μg dose groups was similar to the median magnitude in convalescent serum specimens, and in all dose groups the median magnitude after the second vaccination was in the upper quartile of values in the convalescent serum specimens.

    The S-2P ELISA GMTs at day 57 (299,751 [95% confidence interval {CI}, 206,071 to 436,020] in the 25-μg group, 782,719 [95% CI, 619,310 to 989,244] in the 100-μg group, and 1,192,154 [95% CI, 924,878 to 1,536,669] in the 250-μg group) exceeded that in the convalescent serum specimens (142,140 [95% CI, 81,543 to 247,768]). SARS-CoV-2 Neutralization Responses No participant had detectable PsVNA responses before vaccination. After the first vaccination, PsVNA responses were detected in less than half the participants, and a dose effect was seen (50% inhibitory dilution [ID50]. Figure 2C, Fig. S8, and Table 2.

    80% inhibitory dilution [ID80]. Fig. S2 and Table S6). However, after the second vaccination, PsVNA responses were identified in serum samples from all participants. The lowest responses were in the 25-μg dose group, with a geometric mean ID50 of 112.3 (95% CI, 71.2 to 177.1) at day 43.

    The higher responses in the 100-μg and 250-μg groups were similar in magnitude (geometric mean ID50, 343.8 [95% CI, 261.2 to 452.7] and 332.2 [95% CI, 266.3 to 414.5], respectively, at day 43). These responses were similar to values in the upper half of the distribution of values for convalescent serum specimens. Before vaccination, no participant had detectable 80% live-virus neutralization at the highest serum concentration tested (1:8 dilution) in the PRNT assay. At day 43, wild-type virus–neutralizing activity capable of reducing SARS-CoV-2 infectivity by 80% or more (PRNT80) was detected in all participants, with geometric mean PRNT80 responses of 339.7 (95% CI, 184.0 to 627.1) in the 25-μg group and 654.3 (95% CI, 460.1 to 930.5) in the 100-μg group (Figure 2D). Neutralizing PRNT80 average responses were generally at or above the values of the three convalescent serum specimens tested in this assay.

    Good agreement was noted within and between the values from binding assays for S-2P and receptor-binding domain and neutralizing activity measured by PsVNA and PRNT (Figs. S3 through S7), which provides orthogonal support for each assay in characterizing the humoral response induced by mRNA-1273. SARS-CoV-2 T-Cell Responses The 25-μg and 100-μg doses elicited CD4 T-cell responses (Figs. S9 and S10) that on stimulation by S-specific peptide pools were strongly biased toward expression of Th1 cytokines (tumor necrosis factor α >. Interleukin 2 >.

    Interferon γ), with minimal type 2 helper T-cell (Th2) cytokine expression (interleukin 4 and interleukin 13). CD8 T-cell responses to S-2P were detected at low levels after the second vaccination in the 100-μg dose group (Fig. S11).Patients Figure 1. Figure 1. Enrollment and Randomization.

    Of the 1107 patients who were assessed for eligibility, 1063 underwent randomization. 541 were assigned to the remdesivir group and 522 to the placebo group (Figure 1). Of those assigned to receive remdesivir, 531 patients (98.2%) received the treatment as assigned. Forty-nine patients had remdesivir treatment discontinued before day 10 because of an adverse event or a serious adverse event other than death (36 patients) or because the patient withdrew consent (13). Of those assigned to receive placebo, 518 patients (99.2%) received placebo as assigned.

    Fifty-three patients discontinued placebo before day 10 because of an adverse event or a serious adverse event other than death (36 patients), because the patient withdrew consent (15), or because the patient was found to be ineligible for trial enrollment (2). As of April 28, 2020, a total of 391 patients in the remdesivir group and 340 in the placebo group had completed the trial through day 29, recovered, or died. Eight patients who received remdesivir and 9 who received placebo terminated their participation in the trial before day 29. There were 132 patients in the remdesivir group and 169 in the placebo group who had not recovered and had not completed the day 29 follow-up visit. The analysis population included 1059 patients for whom we have at least some postbaseline data available (538 in the remdesivir group and 521 in the placebo group).

    Four of the 1063 patients were not included in the primary analysis because no postbaseline data were available at the time of the database freeze. Table 1. Table 1. Demographic and Clinical Characteristics at Baseline. The mean age of patients was 58.9 years, and 64.3% were male (Table 1).

    On the basis of the evolving epidemiology of Covid-19 during the trial, 79.8% of patients were enrolled at sites in North America, 15.3% in Europe, and 4.9% in Asia (Table S1). Overall, 53.2% of the patients were white, 20.6% were black, 12.6% were Asian, and 13.6% were designated as other or not reported. 249 (23.4%) were Hispanic or Latino. Most patients had either one (27.0%) or two or more (52.1%) of the prespecified coexisting conditions at enrollment, most commonly hypertension (49.6%), obesity (37.0%), and type 2 diabetes mellitus (29.7%). The median number of days between symptom onset and randomization was 9 (interquartile range, 6 to 12).

    Nine hundred forty-three (88.7%) patients had severe disease at enrollment as defined in the Supplementary Appendix. 272 (25.6%) patients met category 7 criteria on the ordinal scale, 197 (18.5%) category 6, 421 (39.6%) category 5, and 127 (11.9%) category 4. There were 46 (4.3%) patients who had missing ordinal scale data at enrollment. No substantial imbalances in baseline characteristics were observed between the remdesivir group and the placebo group. Primary Outcome Figure 2.

    Figure 2. Kaplan–Meier Estimates of Cumulative Recoveries. Cumulative recovery estimates are shown in the overall population (Panel A), in patients with a baseline score of 4 on the ordinal scale (not receiving oxygen. Panel B), in those with a baseline score of 5 (receiving oxygen. Panel C), in those with a baseline score of 6 (receiving high-flow oxygen or noninvasive mechanical ventilation.

    Panel D), and in those with a baseline score of 7 (receiving mechanical ventilation or ECMO. Panel E). Table 2. Table 2. Outcomes Overall and According to Score on the Ordinal Scale in the Intention-to-Treat Population.

    Figure 3. Figure 3. Time to Recovery According to Subgroup. The widths of the confidence intervals have not been adjusted for multiplicity and therefore cannot be used to infer treatment effects. Race and ethnic group were reported by the patients.

    Patients in the remdesivir group had a shorter time to recovery than patients in the placebo group (median, 11 days, as compared with 15 days. Rate ratio for recovery, 1.32. 95% confidence interval [CI], 1.12 to 1.55. P<0.001. 1059 patients (Figure 2 and Table 2).

    Among patients with a baseline ordinal score of 5 (421 patients), the rate ratio for recovery was 1.47 (95% CI, 1.17 to 1.84). Among patients with a baseline score of 4 (127 patients) and those with a baseline score of 6 (197 patients), the rate ratio estimates for recovery were 1.38 (95% CI, 0.94 to 2.03) and 1.20 (95% CI, 0.79 to 1.81), respectively. For those receiving mechanical ventilation or ECMO at enrollment (baseline ordinal scores of 7. 272 patients), the rate ratio for recovery was 0.95 (95% CI, 0.64 to 1.42). A test of interaction of treatment with baseline score on the ordinal scale was not significant.

    An analysis adjusting for baseline ordinal score as a stratification variable was conducted to evaluate the overall effect (of the percentage of patients in each ordinal score category at baseline) on the primary outcome. This adjusted analysis produced a similar treatment-effect estimate (rate ratio for recovery, 1.31. 95% CI, 1.12 to 1.54. 1017 patients). Table S2 in the Supplementary Appendix shows results according to the baseline severity stratum of mild-to-moderate as compared with severe.

    Patients who underwent randomization during the first 10 days after the onset of symptoms had a rate ratio for recovery of 1.28 (95% CI, 1.05 to 1.57. 664 patients), whereas patients who underwent randomization more than 10 days after the onset of symptoms had a rate ratio for recovery of 1.38 (95% CI, 1.05 to 1.81. 380 patients) (Figure 3). Key Secondary Outcome The odds of improvement in the ordinal scale score were higher in the remdesivir group, as determined by a proportional odds model at the day 15 visit, than in the placebo group (odds ratio for improvement, 1.50. 95% CI, 1.18 to 1.91.

    P=0.001. 844 patients) (Table 2 and Fig. S5). Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant (hazard ratio for death, 0.70. 95% CI, 0.47 to 1.04.

    1059 patients). The Kaplan–Meier estimates of mortality by 14 days were 7.1% and 11.9% in the remdesivir and placebo groups, respectively (Table 2). The Kaplan–Meier estimates of mortality by 28 days are not reported in this preliminary analysis, given the large number of patients that had yet to complete day 29 visits. An analysis with adjustment for baseline ordinal score as a stratification variable showed a hazard ratio for death of 0.74 (95% CI, 0.50 to 1.10). Safety Outcomes Serious adverse events occurred in 114 patients (21.1%) in the remdesivir group and 141 patients (27.0%) in the placebo group (Table S3).

    4 events (2 in each group) were judged by site investigators to be related to remdesivir or placebo. There were 28 serious respiratory failure adverse events in the remdesivir group (5.2% of patients) and 42 in the placebo group (8.0% of patients). Acute respiratory failure, hypotension, viral pneumonia, and acute kidney injury were slightly more common among patients in the placebo group. No deaths were considered to be related to treatment assignment, as judged by the site investigators. Grade 3 or 4 adverse events occurred in 156 patients (28.8%) in the remdesivir group and in 172 in the placebo group (33.0%) (Table S4).

    The most common adverse events in the remdesivir group were anemia or decreased hemoglobin (43 events [7.9%], as compared with 47 [9.0%] in the placebo group). Acute kidney injury, decreased estimated glomerular filtration rate or creatinine clearance, or increased blood creatinine (40 events [7.4%], as compared with 38 [7.3%]). Pyrexia (27 events [5.0%], as compared with 17 [3.3%]). Hyperglycemia or increased blood glucose level (22 events [4.1%], as compared with 17 [3.3%]). And increased aminotransferase levels including alanine aminotransferase, aspartate aminotransferase, or both (22 events [4.1%], as compared with 31 [5.9%]).

    Otherwise, the incidence of adverse events was not found to be significantly different between the remdesivir group and the placebo group.Announced on May 15, Operation Warp Speed (OWS) — a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector — aims to accelerate control of the Covid-19 pandemic by advancing development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics. OWS is providing support to promising candidates and enabling the expeditious, parallel execution of the necessary steps toward approval or authorization of safe products by the Food and Drug Administration (FDA).The partnership grew out of an acknowledged need to fundamentally restructure the way the U.S. Government typically supports product development and vaccine distribution. The initiative was premised on setting a “stretch goal” — one that initially seemed impossible but that is becoming increasingly achievable.The concept of an integrated structure for Covid-19 countermeasure research and development across the U.S. Government was based on experience with Zika and the Zika Leadership Group led by the National Institutes of Health (NIH) and the assistant secretary for preparedness and response (ASPR).

    One of us (M.S.) serves as OWS chief advisor. We are drawing on expertise from the NIH, ASPR, the Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority (BARDA), and the DOD, including the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the Defense Advanced Research Projects Agency. OWS has engaged experts in all critical aspects of medical countermeasure research, development, manufacturing, and distribution to work in close coordination.The initiative set ambitious objectives. To deliver tens of millions of doses of a SARS-CoV-2 vaccine — with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S. Population — beginning at the end of 2020 and to have as many as 300 million doses of such vaccines available and deployed by mid-2021.

    The pace and scope of such a vaccine effort are unprecedented. The 2014 West African Ebola virus epidemic spurred rapid vaccine development, but though preclinical data existed before the outbreak, a period of 12 months was required to progress from phase 1 first-in-human trials to phase 3 efficacy trials. OWS aims to compress this time frame even further. SARS-CoV-2 vaccine development began in January, phase 1 clinical studies in March, and the first phase 3 trials in July. Our objectives are based on advances in vaccine platform technology, improved understanding of safe and efficacious vaccine design, and similarities between the SARS-CoV-1 and SARS-CoV-2 disease mechanisms.OWS’s role is to enable, accelerate, harmonize, and advise the companies developing the selected vaccines.

    The companies will execute the clinical or process development and manufacturing plans, while OWS leverages the full capacity of the U.S. Government to ensure that no technical, logistic, or financial hurdles hinder vaccine development or deployment.OWS selected vaccine candidates on the basis of four criteria. We required candidates to have robust preclinical data or early-stage clinical trial data supporting their potential for clinical safety and efficacy. Candidates had to have the potential, with our acceleration support, to enter large phase 3 field efficacy trials this summer or fall (July to November 2020) and, assuming continued active transmission of the virus, to deliver efficacy outcomes by the end of 2020 or the first half of 2021. Candidates had to be based on vaccine-platform technologies permitting fast and effective manufacturing, and their developers had to demonstrate the industrial process scalability, yields, and consistency necessary to reliably produce more than 100 million doses by mid-2021.

    Finally, candidates had to use one of four vaccine-platform technologies that we believe are the most likely to yield a safe and effective vaccine against Covid-19. The mRNA platform, the replication-defective live-vector platform, the recombinant-subunit-adjuvanted protein platform, or the attenuated replicating live-vector platform.OWS’s strategy relies on a few key principles. First, we sought to build a diverse project portfolio that includes two vaccine candidates based on each of the four platform technologies. Such diversification mitigates the risk of failure due to safety, efficacy, industrial manufacturability, or scheduling factors and may permit selection of the best vaccine platform for each subpopulation at risk for contracting or transmitting Covid-19, including older adults, frontline and essential workers, young adults, and pediatric populations. In addition, advancing eight vaccines in parallel will increase the chances of delivering 300 million doses in the first half of 2021.Second, we must accelerate vaccine program development without compromising safety, efficacy, or product quality.

    Clinical development, process development, and manufacturing scale-up can be substantially accelerated by running all streams, fully resourced, in parallel. Doing so requires taking on substantial financial risk, as compared with the conventional sequential development approach. OWS will maximize the size of phase 3 trials (30,000 to 50,000 participants each) and optimize trial-site location by consulting daily epidemiologic and disease-forecasting models to ensure the fastest path to an efficacy readout. Such large trials also increase the safety data set for each candidate vaccine.With heavy up-front investment, companies can conduct clinical operations and site preparation for these phase 3 efficacy trials even as they file their Investigational New Drug application (IND) for their phase 1 studies, thereby ensuring immediate initiation of phase 3 when they get a green light from the FDA. To permit appropriate comparisons among the vaccine candidates and to optimize vaccine utilization after approval by the FDA, the phase 3 trial end points and assay readouts have been harmonized through a collaborative effort involving the National Institute of Allergy and Infectious Diseases (NIAID), the Coronavirus Prevention Network, OWS, and the sponsor companies.Finally, OWS is supporting the companies financially and technically to commence process development and scale up manufacturing while their vaccines are in preclinical or very early clinical stages.

    To ensure that industrial processes are set, running, and validated for FDA inspection when phase 3 trials end, OWS is also supporting facility building or refurbishing, equipment fitting, staff hiring and training, raw-material sourcing, technology transfer and validation, bulk product processing into vials, and acquisition of ample vials, syringes, and needles for each vaccine candidate. We aim to have stockpiled, at OWS’s expense, a few tens of millions of vaccine doses that could be swiftly deployed once FDA approval is obtained.This strategy aims to accelerate vaccine development without curtailing the critical steps required by sound science and regulatory standards. The FDA recently reissued guidance and standards that will be used to assess each vaccine for a Biologics License Application (BLA). Alternatively, the agency could decide to issue an Emergency Use Authorization to permit vaccine administration before all BLA procedures are completed.Of the eight vaccines in OWS’s portfolio, six have been announced and partnerships executed with the companies. Moderna and Pfizer/BioNTech (both mRNA), AstraZeneca and Janssen (both replication-defective live-vector), and Novavax and Sanofi/GSK (both recombinant-subunit-adjuvanted protein).

    These candidates cover three of the four platform technologies and are currently in clinical trials. The remaining two candidates will enter trials soon.Moderna developed its RNA vaccine in collaboration with the NIAID, began its phase 1 trial in March, recently published encouraging safety and immunogenicity data,1 and entered phase 3 on July 27. Pfizer and BioNTech’s RNA vaccine also produced encouraging phase 1 results2 and started its phase 3 trial on July 27. The ChAdOx replication-defective live-vector vaccine developed by AstraZeneca and Oxford University is in phase 3 trials in the United Kingdom, Brazil, and South Africa, and it should enter U.S. Phase 3 trials in August.3 The Janssen Ad26 Covid-19 replication-defective live-vector vaccine has demonstrated excellent protection in nonhuman primate models and began its U.S.

    Phase 1 trial on July 27. It should be in phase 3 trials in mid-September. Novavax completed a phase 1 trial of its recombinant-subunit-adjuvanted protein vaccine in Australia and should enter phase 3 trials in the United States by the end of September.4 Sanofi/GSK is completing preclinical development steps and plans to commence a phase 1 trial in early September and to be well into phase 3 by year’s end.5On the process-development front, the RNA vaccines are already being manufactured at scale. The other candidates are well advanced in their scale-up development, and manufacturing sites are being refurbished.While development and manufacturing proceed, the HHS–DOD partnership is laying the groundwork for vaccine distribution, subpopulation prioritization, financing, and logistic support. We are working with bioethicists and experts from the NIH, the CDC, BARDA, and the Centers for Medicare and Medicaid Services to address these critical issues.

    We will receive recommendations from the CDC Advisory Committee on Immunization Practices, and we are working to ensure that the most vulnerable and at-risk persons will receive vaccine doses once they are ready. Prioritization will also depend on the relative performance of each vaccine and its suitability for particular populations. Because some technologies have limited previous data on safety in humans, the long-term safety of these vaccines will be carefully assessed using pharmacovigilance surveillance strategies.No scientific enterprise could guarantee success by January 2021, but the strategic decisions and choices we’ve made, the support the government has provided, and the accomplishments to date make us optimistic that we will succeed in this unprecedented endeavor.Trial Design and Oversight We conducted a randomized, double-blind, placebo-controlled trial to evaluate postexposure prophylaxis with hydroxychloroquine after exposure to Covid-19.12 We randomly assigned participants in a 1:1 ratio to receive either hydroxychloroquine or placebo. Participants had known exposure (by participant report) to a person with laboratory-confirmed Covid-19, whether as a household contact, a health care worker, or a person with other occupational exposures. Trial enrollment began on March 17, 2020, with an eligibility threshold to enroll within 3 days after exposure.

    The objective was to intervene before the median incubation period of 5 to 6 days. Because of limited access to prompt testing, health care workers could initially be enrolled on the basis of presumptive high-risk exposure to patients with pending tests. However, on March 23, eligibility was changed to exposure to a person with a positive polymerase-chain-reaction (PCR) assay for SARS-CoV-2, with the eligibility window extended to within 4 days after exposure. This trial was approved by the institutional review board at the University of Minnesota and conducted under a Food and Drug Administration Investigational New Drug application. In Canada, the trial was approved by Health Canada.

    Ethics approvals were obtained from the Research Institute of the McGill University Health Centre, the University of Manitoba, and the University of Alberta. Participants We included participants who had household or occupational exposure to a person with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure). Participants were excluded if they were younger than 18 years of age, were hospitalized, or met other exclusion criteria (see the Supplementary Appendix, available with the full text of this article at NEJM.org). Persons with symptoms of Covid-19 or with PCR-proven SARS-CoV-2 infection were excluded from this prevention trial but were separately enrolled in a companion clinical trial to treat early infection. Setting Recruitment was performed primarily with the use of social media outreach as well as traditional media platforms.

    Participants were enrolled nationwide in the United States and in the Canadian provinces of Quebec, Manitoba, and Alberta. Participants enrolled themselves through a secure Internet-based survey using the Research Electronic Data Capture (REDCap) system.13 After participants read the consent form, their comprehension of its contents was assessed. Participants provided a digitally captured signature to indicate informed consent. We sent follow-up e-mail surveys on days 1, 5, 10, and 14. A survey at 4 to 6 weeks asked about any follow-up testing, illness, or hospitalizations.

    Participants who did not respond to follow-up surveys received text messages, e-mails, telephone calls, or a combination of these to ascertain their outcomes. When these methods were unsuccessful, the emergency contact provided by the enrollee was contacted to determine the participant’s illness and vital status. When all communication methods were exhausted, Internet searches for obituaries were performed to ascertain vital status. Interventions Randomization occurred at research pharmacies in Minneapolis and Montreal. The trial statisticians generated a permuted-block randomization sequence using variably sized blocks of 2, 4, or 8, with stratification according to country.

    A research pharmacist sequentially assigned participants. The assignments were concealed from investigators and participants. Only pharmacies had access to the randomization sequence. Hydroxychloroquine sulfate or placebo was dispensed and shipped overnight to participants by commercial courier. The dosing regimen for hydroxychloroquine was 800 mg (4 tablets) once, then 600 mg (3 tablets) 6 to 8 hours later, then 600 mg (3 tablets) daily for 4 more days for a total course of 5 days (19 tablets total).

    If participants had gastrointestinal upset, they were advised to divide the daily dose into two or three doses. We chose this hydroxychloroquine dosing regimen on the basis of pharmacokinetic simulations to achieve plasma concentrations above the SARS-CoV-2 in vitro half maximal effective concentration for 14 days.14 Placebo folate tablets, which were similar in appearance to the hydroxychloroquine tablets, were prescribed as an identical regimen for the control group. Rising Pharmaceuticals provided a donation of hydroxychloroquine, and some hydroxychloroquine was purchased. Outcomes The primary outcome was prespecified as symptomatic illness confirmed by a positive molecular assay or, if testing was unavailable, Covid-19–related symptoms. We assumed that health care workers would have access to Covid-19 testing if symptomatic.

    However, access to testing was limited throughout the trial period. Covid-19–related symptoms were based on U.S. Council for State and Territorial Epidemiologists criteria for confirmed cases (positivity for SARS-Cov-2 on PCR assay), probable cases (the presence of cough, shortness of breath, or difficulty breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).15 All the participants had epidemiologic linkage,15 per trial eligibility criteria. Four infectious disease physicians who were unaware of the trial-group assignments reviewed symptomatic participants to generate a consensus with respect to whether their condition met the case definition.15 Secondary outcomes included the incidence of hospitalization for Covid-19 or death, the incidence of PCR-confirmed SARS-CoV-2 infection, the incidence of Covid-19 symptoms, the incidence of discontinuation of the trial intervention owing to any cause, and the severity of symptoms (if any) at days 5 and 14 according to a visual analogue scale (scores ranged from 0 [no symptoms] to 10 [severe symptoms]). Data on adverse events were also collected with directed questioning for common side effects along with open-ended free text.

    Outcome data were measured within 14 days after trial enrollment. Outcome data including PCR testing results, possible Covid-19–related symptoms, adherence to the trial intervention, side effects, and hospitalizations were all collected through participant report. Details of trial conduct are provided in the protocol and statistical analysis plan, available at NEJM.org. Sample Size We anticipated that illness compatible with Covid-19 would develop in 10% of close contacts exposed to Covid-19.9 Using Fisher’s exact method with a 50% relative effect size to reduce new symptomatic infections, a two-sided alpha of 0.05, and 90% power, we estimated that 621 persons would need to be enrolled in each group. With a pragmatic, Internet-based, self-referral recruitment strategy, we planned for a 20% incidence of attrition by increasing the sample size to 750 participants per group.

    We specified a priori that participants who were already symptomatic on day 1 before receiving hydroxychloroquine or placebo would be excluded from the prophylaxis trial and would instead be separately enrolled in the companion symptomatic treatment trial. Because the estimates for both incident symptomatic Covid-19 after an exposure and loss to follow-up were relatively unknown in early March 2020,9 the protocol prespecified a sample-size reestimation at the second interim analysis. This reestimation, which used the incidence of new infections in the placebo group and the observed percentage of participants lost to follow-up, was aimed at maintaining the ability to detect an effect size of a 50% relative reduction in new symptomatic infections. Interim Analyses An independent data and safety monitoring board externally reviewed the data after 25% and 50% of the participants had completed 14 days of follow-up. Stopping guidelines were provided to the data and safety monitoring board with the use of a Lan–DeMets spending function analogue of the O’Brien–Fleming boundaries for the primary outcome.

    A conditional power analysis was performed at the second and third interim analysis with the option of early stopping for futility. At the second interim analysis on April 22, 2020, the sample size was reduced to 956 participants who could be evaluated with 90% power on the basis of the higher-than-expected event rate of infections in the control group. At the third interim analysis on May 6, the trial was halted on the basis of a conditional power of less than 1%, since it was deemed futile to continue. Statistical Analysis We assessed the incidence of Covid-19 disease by day 14 with Fisher’s exact test. Secondary outcomes with respect to percentage of patients were also compared with Fisher’s exact test.

    Among participants in whom incident illness compatible with Covid-19 developed, we summarized the symptom severity score at day 14 with the median and interquartile range and assessed the distributions with a Kruskal–Wallis test. We conducted all analyses with SAS software, version 9.4 (SAS Institute), according to the intention-to-treat principle, with two-sided type I error with an alpha of 0.05. For participants with missing outcome data, we conducted a sensitivity analysis with their outcomes excluded or included as an event. Subgroups that were specified a priori included type of contact (household vs. Health care), days from exposure to enrollment, age, and sex.Trial Design and Oversight The RECOVERY trial was designed to evaluate the effects of potential treatments in patients hospitalized with Covid-19 at 176 National Health Service organizations in the United Kingdom and was supported by the National Institute for Health Research Clinical Research Network.

    (Details regarding this trial are provided in the Supplementary Appendix, available with the full text of this article at NEJM.org.) The trial is being coordinated by the Nuffield Department of Population Health at the University of Oxford, the trial sponsor. Although the randomization of patients to receive dexamethasone, hydroxychloroquine, or lopinavir–ritonavir has now been stopped, the trial continues randomization to groups receiving azithromycin, tocilizumab, or convalescent plasma. Hospitalized patients were eligible for the trial if they had clinically suspected or laboratory-confirmed SARS-CoV-2 infection and no medical history that might, in the opinion of the attending clinician, put patients at substantial risk if they were to participate in the trial. Initially, recruitment was limited to patients who were at least 18 years of age, but the age limit was removed starting on May 9, 2020. Pregnant or breast-feeding women were eligible.

    Written informed consent was obtained from all the patients or from a legal representative if they were unable to provide consent. The trial was conducted in accordance with the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation and was approved by the U.K. Medicines and Healthcare Products Regulatory Agency and the Cambridge East Research Ethics Committee. The protocol with its statistical analysis plan is available at NEJM.org and on the trial website at www.recoverytrial.net. The initial version of the manuscript was drafted by the first and last authors, developed by the writing committee, and approved by all members of the trial steering committee.

    The funders had no role in the analysis of the data, in the preparation or approval of the manuscript, or in the decision to submit the manuscript for publication. The first and last members of the writing committee vouch for the completeness and accuracy of the data and for the fidelity of the trial to the protocol and statistical analysis plan. Randomization We collected baseline data using a Web-based case-report form that included demographic data, the level of respiratory support, major coexisting illnesses, suitability of the trial treatment for a particular patient, and treatment availability at the trial site. Randomization was performed with the use of a Web-based system with concealment of the trial-group assignment. Eligible and consenting patients were assigned in a 2:1 ratio to receive either the usual standard of care alone or the usual standard of care plus oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days (or until hospital discharge if sooner) or to receive one of the other suitable and available treatments that were being evaluated in the trial.

    For some patients, dexamethasone was unavailable at the hospital at the time of enrollment or was considered by the managing physician to be either definitely indicated or definitely contraindicated. These patients were excluded from entry in the randomized comparison between dexamethasone and usual care and hence were not included in this report. The randomly assigned treatment was prescribed by the treating clinician. Patients and local members of the trial staff were aware of the assigned treatments. Procedures A single online follow-up form was to be completed when the patients were discharged or had died or at 28 days after randomization, whichever occurred first.

    Information was recorded regarding the patients’ adherence to the assigned treatment, receipt of other trial treatments, duration of admission, receipt of respiratory support (with duration and type), receipt of renal support, and vital status (including the cause of death). In addition, we obtained routine health care and registry data, including information on vital status (with date and cause of death), discharge from the hospital, and respiratory and renal support therapy. Outcome Measures The primary outcome was all-cause mortality within 28 days after randomization. Further analyses were specified at 6 months. Secondary outcomes were the time until discharge from the hospital and, among patients not receiving invasive mechanical ventilation at the time of randomization, subsequent receipt of invasive mechanical ventilation (including extracorporeal membrane oxygenation) or death.

    Other prespecified clinical outcomes included cause-specific mortality, receipt of renal hemodialysis or hemofiltration, major cardiac arrhythmia (recorded in a subgroup), and receipt and duration of ventilation. Statistical Analysis As stated in the protocol, appropriate sample sizes could not be estimated when the trial was being planned at the start of the Covid-19 pandemic. As the trial progressed, the trial steering committee, whose members were unaware of the results of the trial comparisons, determined that if 28-day mortality was 20%, then the enrollment of at least 2000 patients in the dexamethasone group and 4000 in the usual care group would provide a power of at least 90% at a two-sided P value of 0.01 to detect a clinically relevant proportional reduction of 20% (an absolute difference of 4 percentage points) between the two groups. Consequently, on June 8, 2020, the steering committee closed recruitment to the dexamethasone group, since enrollment had exceeded 2000 patients. For the primary outcome of 28-day mortality, the hazard ratio from Cox regression was used to estimate the mortality rate ratio.

    Among the few patients (0.1%) who had not been followed for 28 days by the time of the data cutoff on July 6, 2020, data were censored either on that date or on day 29 if the patient had already been discharged. That is, in the absence of any information to the contrary, these patients were assumed to have survived for 28 days. Kaplan–Meier survival curves were constructed to show cumulative mortality over the 28-day period. Cox regression was used to analyze the secondary outcome of hospital discharge within 28 days, with censoring of data on day 29 for patients who had died during hospitalization. For the prespecified composite secondary outcome of invasive mechanical ventilation or death within 28 days (among patients who were not receiving invasive mechanical ventilation at randomization), the precise date of invasive mechanical ventilation was not available, so a log-binomial regression model was used to estimate the risk ratio.

    Table 1. Table 1. Characteristics of the Patients at Baseline, According to Treatment Assignment and Level of Respiratory Support. Through the play of chance in the unstratified randomization, the mean age was 1.1 years older among patients in the dexamethasone group than among those in the usual care group (Table 1). To account for this imbalance in an important prognostic factor, estimates of rate ratios were adjusted for the baseline age in three categories (<70 years, 70 to 79 years, and ≥80 years).

    This adjustment was not specified in the first version of the statistical analysis plan but was added once the imbalance in age became apparent. Results without age adjustment (corresponding to the first version of the analysis plan) are provided in the Supplementary Appendix. Prespecified analyses of the primary outcome were performed in five subgroups, as defined by characteristics at randomization. Age, sex, level of respiratory support, days since symptom onset, and predicted 28-day mortality risk. (One further prespecified subgroup analysis regarding race will be conducted once the data collection has been completed.) In prespecified subgroups, we estimated rate ratios (or risk ratios in some analyses) and their confidence intervals using regression models that included an interaction term between the treatment assignment and the subgroup of interest.

    Chi-square tests for linear trend across the subgroup-specific log estimates were then performed in accordance with the prespecified plan. All P values are two-sided and are shown without adjustment for multiple testing. All analyses were performed according to the intention-to-treat principle. The full database is held by the trial team, which collected the data from trial sites and performed the analyses at the Nuffield Department of Population Health, University of Oxford..

    Metformin lipitor

    Medicare Savings Programs (MSPs) pay for the monthly Medicare Part metformin lipitor B premium for low-income Medicare beneficiaries and qualify enrollees for the "Extra Help" subsidy for Part D prescription drugs. There are three separate MSP programs, the Qualified Medicare Beneficiary (QMB) Program, the Specified Low Income Medicare Beneficiary (SLMB) Program and the Qualified Individual (QI) Program, each of which is discussed below. Those in QMB receive additional subsidies for Medicare costs. See 2019 Fact Sheet metformin lipitor on MSP in NYS by Medicare Rights Center ENGLISH SPANISH State law.

    § 367-a(3)(a), (b), and (d). 2020 Medicare 101 Basics for New York State - 1.5 hour webinar by Eric Hausman, sponsored by NYS Office of the Aging TOPICS COVERED IN THIS ARTICLE 1. No Asset Limit 1A. Summary Chart of MSP Programs 2.

    Income Limits &. Rules and Household Size 3. The Three MSP Programs - What are they and how are they Different?. 4.

    FOUR Special Benefits of MSP Programs. Back Door to Extra Help with Part D MSPs Automatically Waive Late Enrollment Penalties for Part B - and allow enrollment in Part B year-round outside of the short Annual Enrollment Period No Medicaid Lien on Estate to Recover Payment of Expenses Paid by MSP Food Stamps/SNAP not reduced by Decreased Medical Expenses when Enroll in MSP - at least temporarily 5. Enrolling in an MSP - Automatic Enrollment &. Applications for People who Have Medicare What is Application Process?.

    6. Enrolling in an MSP for People age 65+ who Do Not Qualify for Free Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP Approved - How Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1. NO ASSET LIMIT!.

    Since April 1, 2008, none of the three MSP programs have resource limits in New York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP. 1.A. SUMMARY CHART OF MSP BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2020) Single Couple Single Couple Single Couple $1,064 $1,437 $1,276 $1,724 $1,436 $1,940 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?. YES, and also Part A premium if did not have enough work quarters and meets citizenship requirement.

    See “Part A Buy-In” YES YES Pays Part A &. B deductibles &. Co-insurance YES - with limitations NO NO Retroactive to Filing of Application?. Yes - Benefits begin the month after the month of the MSP application.

    18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year. (No retro for January application). See GIS 07 MA 027. Can Enroll in MSP and Medicaid at Same Time?.

    YES YES NO!. Must choose between QI-1 and Medicaid. Cannot have both, not even Medicaid with a spend-down. 2.

    INCOME LIMITS and RULES Each of the three MSP programs has different income eligibility requirements and provides different benefits. The income limits are tied to the Federal Poverty Level (FPL). 2019 FPL levels were released by NYS DOH in GIS 20 MA/02 - 2020 Federal Poverty Levels -- Attachment II and have been posted by Medicaid.gov and the National Council on Aging and are in the chart below. NOTE.

    There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are release, and then before the new MSP income limits are officially implemented. During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security COLA (cost of living adjustment). Once the updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2019 Fact Sheet on MSP in NYS by Medicare Rights Center ENGLISH SPANISH Income is determined by the same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples.

    367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7. Gross income is counted, although there are certain types of income that are disregarded. The most common income disregards, also known as deductions, include. (a) The first $20 of your &.

    Your spouse's monthly income, earned or unearned ($20 per couple max). (b) SSI EARNED INCOME DISREGARDS. * The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc.

    For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind. (c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted. You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart. As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher.

    The above chart shows that Households of TWO have a higher income limit than households of ONE. The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO. 18 NYCRR 360-4.2. See DAB Household Size Chart.

    Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP. EXAMPLE. Bob's Social Security is $1300/month. He is age 67 and has Medicare.

    His wife, Nancy, is age 62 and is not disabled and does not work. Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit. In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO. DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010.

    This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program. Under these rules, Bob is now eligible for an MSP. When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP.

    In such cases, "spousal refusal" may be used SSL 366.3(a). (Link is to NYC HRA form, can be adapted for other counties). 3. The Three Medicare Savings Programs - what are they and how are they different?.

    1. Qualified Medicare Beneficiary (QMB). The QMB program provides the most comprehensive benefits. Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations.

    Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance. QMB coverage is not retroactive. The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center).

    2. Specifiedl Low-Income Medicare Beneficiary (SLMB). For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only. SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

    3. Qualified Individual (QI-1). For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only. QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

    However, QI-1 retroactive coverage can only be provided within the current calendar year. (GIS 07 MA 027) So if you apply in January, you get no retroactive coverage. Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both.

    It is their choice. DOH MRG p. 19. In contrast, one may receive Medicaid and either QMB or SLIMB.

    4. Four Special Benefits of MSPs (in addition to NO ASSET TEST). Benefit 1. Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable.

    They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments. Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year. The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL. However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit.

    People applying to the Social Security Administration for Extra Help might be rejected for this reason. Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy. Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application.

    Signatures will not be required from clients. In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application. The State implementing procedures are in DOH 2010 ADM-03. Also see CMS "Dear State Medicaid Director" letter dated Feb.

    18, 2010 Benefit 2. MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability. An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP).

    Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July. Enrollment in an MSP automatically eliminates such penalties... For life.. Even if one later ceases to be eligible for the MSP.

    AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A. See Medicare Rights Center flyer. Benefit 3. No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55.

    Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs. In 2010, Congress expanded protection for MSP benefits. Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs.

    See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses. Benefit 4. SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium.

    Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down. Here are some protections. Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?. And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?.

    The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification. Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification. New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification.

    Most elderly and disabled households have 24-month SNAP certification periods. Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit. It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar. A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits.

    See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website. Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare. Others need to apply. The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment.

    See 3rd bullet below. Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP. See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP.

    Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare. They should receive Medicare Parts A and B. Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033).

    Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &. Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing. Strategy TIP. Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason.

    SSA processes these requests quickly, and it will be routed to the State for MSP processing. Since MSP applications take a while, at least the filing date will be retroactive. Note. The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application.

    As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1. Applying for MSP Directly with Local Medicaid Program. Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D.

    Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare. If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev. 8/2017-- English) (2017 Spanish version not yet available). Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid.

    See 10 ADM-04. Applicants will need to submit proof of income, a copy of their Medicare card (front &. Back), and proof of residency/address. See the application form for other instructions.

    One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too. One may not receive Medicaid and QI-1 at the same time. If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person.

    Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program. In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan. GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare. To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district.

    The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability. Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification. NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare.

    IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district. See 2014 LCM-02. Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare.

    People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals. Since MSP has NO ASSET limit. Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down. If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP.

    08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare. This is called Continuous Eligibility. EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016.

    He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability). Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016. Sam has to pay for his Part B premium - it is deducted from his Social Security check. He may call the Marketplace and request a refund.

    This will continue until the end of his 12 months of continues MAGI Medicaid eligibility. He will be reimbursed regardless of whether he is in a Medicaid managed care plan. See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district. Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP.

    (Medicaid Reference Guide (MRG) p. 19). Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply.

    The letters are. · Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6. Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center).

    This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium. See also GIS 04 MA/013. In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment. The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as.

    SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements. SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program. Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums. In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period.

    (The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st). 7. What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check.

    No Asset lipitor cost per pill Limit 1A. Summary Chart of MSP Programs 2. Income Limits &. Rules and lipitor cost per pill Household Size 3. The Three MSP Programs - What are they and how are they Different?.

    4. FOUR lipitor cost per pill Special Benefits of MSP Programs. Back Door to Extra Help with Part D MSPs Automatically Waive Late Enrollment Penalties for Part B - and allow enrollment in Part B year-round outside of the short Annual Enrollment Period No Medicaid Lien on Estate to Recover Payment of Expenses Paid by MSP Food Stamps/SNAP not reduced by Decreased Medical Expenses when Enroll in MSP - at least temporarily 5. Enrolling in an MSP - Automatic Enrollment &. Applications for People who Have Medicare What is Application lipitor cost per pill Process?.

    6. Enrolling in an MSP for People age 65+ who Do Not Qualify for Free Medicare Part A - the "Part A Buy-In Program" 7. What Happens After MSP lipitor cost per pill Approved - How Part B Premium is Paid 8 Special Rules for QMBs - How Medicare Cost-Sharing Works 1. NO ASSET LIMIT!. Since April 1, 2008, none of the three MSP programs have resource limits in New York -- which means many Medicare beneficiaries who might not qualify for Medicaid because of excess resources can qualify for an MSP.

    1.A lipitor cost per pill. SUMMARY CHART OF MSP BENEFITS QMB SLIMB QI-1 Eligibility ASSET LIMIT NO LIMIT IN NEW YORK STATE INCOME LIMIT (2020) Single Couple Single Couple Single Couple $1,064 $1,437 $1,276 $1,724 $1,436 $1,940 Federal Poverty Level 100% FPL 100 – 120% FPL 120 – 135% FPL Benefits Pays Monthly Part B premium?. YES, and also Part A premium if did not have enough work quarters and meets citizenship requirement. See “Part A Buy-In” lipitor cost per pill YES YES Pays Part A &. B deductibles &.

    Co-insurance YES - with limitations NO NO Retroactive to Filing of Application?. Yes - Benefits begin the month after the lipitor cost per pill month of the MSP application. 18 NYCRR §360-7.8(b)(5) Yes – Retroactive to 3rd month before month of application, if eligible in prior months Yes – may be retroactive to 3rd month before month of applica-tion, but only within the current calendar year. (No retro for January application). See GIS 07 lipitor cost per pill MA 027.

    Can Enroll in MSP and Medicaid at Same Time?. YES YES NO!. Must choose between QI-1 and Medicaid lipitor cost per pill. Cannot have both, not even Medicaid with a spend-down. 2.

    INCOME LIMITS and RULES Each of the three MSP programs has different income eligibility requirements and lipitor cost per pill provides different benefits. The income limits are tied to the Federal Poverty Level (FPL). 2019 FPL levels were released by NYS DOH in GIS 20 MA/02 - 2020 Federal Poverty Levels -- Attachment II and have been posted by Medicaid.gov and the National Council on Aging and are in the chart below. NOTE lipitor cost per pill. There is usually a lag in time of several weeks, or even months, from January 1st of each year until the new FPLs are release, and then before the new MSP income limits are officially implemented.

    During this lag period, local Medicaid offices should continue to use the previous year's FPLs AND count the person's Social Security benefit amount from the previous year - do NOT factor in the Social Security COLA (cost of living adjustment). Once the lipitor cost per pill updated guidelines are released, districts will use the new FPLs and go ahead and factor in any COLA. See 2019 Fact Sheet on MSP in NYS by Medicare Rights Center ENGLISH SPANISH Income is determined by the same methodology as is used for determining in eligibility for SSI The rules for counting income for SSI-related (Aged 65+, Blind, or Disabled) Medicaid recipients, borrowed from the SSI program, apply to the MSP program, except for the new rules about counting household size for married couples. N.Y. Soc.

    Serv. L. 367-a(3)(c)(2), NYS DOH 2000-ADM-7, 89-ADM-7 p.7. Gross income is counted, although there are certain types of income that are disregarded. The most common income disregards, also known as deductions, include.

    (a) The first $20 of your &. Your spouse's monthly income, earned or unearned ($20 per couple max). (b) SSI EARNED INCOME DISREGARDS. * The first $65 of monthly wages of you and your spouse, * One-half of the remaining monthly wages (after the $65 is deducted). * Other work incentives including PASS plans, impairment related work expenses (IRWEs), blind work expenses, etc.

    For information on these deductions, see The Medicaid Buy-In for Working People with Disabilities (MBI-WPD) and other guides in this article -- though written for the MBI-WPD, the work incentives apply to all Medicaid programs, including MSP, for people age 65+, disabled or blind. (c) monthly cost of any health insurance premiums but NOT the Part B premium, since Medicaid will now pay this premium (may deduct Medigap supplemental policies, vision, dental, or long term care insurance premiums, and the Part D premium but only to the extent the premium exceeds the Extra Help benchmark amount) (d) Food stamps not counted. You can get a more comprehensive listing of the SSI-related income disregards on the Medicaid income disregards chart. As for all benefit programs based on financial need, it is usually advantageous to be considered a larger household, because the income limit is higher. The above chart shows that Households of TWO have a higher income limit than households of ONE.

    The MSP programs use the same rules as Medicaid does for the Disabled, Aged and Blind (DAB) which are borrowed from the SSI program for Medicaid recipients in the “SSI-related category.” Under these rules, a household can be only ONE or TWO. 18 NYCRR 360-4.2. See DAB Household Size Chart. Married persons can sometimes be ONE or TWO depending on arcane rules, which can force a Medicare beneficiary to be limited to the income limit for ONE person even though his spouse who is under 65 and not disabled has no income, and is supported by the client applying for an MSP. EXAMPLE.

    Bob's Social Security is $1300/month. He is age 67 and has Medicare. His wife, Nancy, is age 62 and is not disabled and does not work. Under the old rule, Bob was not eligible for an MSP because his income was above the Income limit for One, even though it was well under the Couple limit. In 2010, NYS DOH modified its rules so that all married individuals will be considered a household size of TWO.

    DOH GIS 10 MA 10 Medicare Savings Program Household Size, June 4, 2010. This rule for household size is an exception to the rule applying SSI budgeting rules to the MSP program. Under these rules, Bob is now eligible for an MSP. When is One Better than Two?. Of course, there may be couples where the non-applying spouse's income is too high, and disqualifies the applying spouse from an MSP.

    In such cases, "spousal refusal" may be used SSL 366.3(a). (Link is to NYC HRA form, can be adapted for other counties). 3. The Three Medicare Savings Programs - what are they and how are they different?. 1.

    Qualified Medicare Beneficiary (QMB). The QMB program provides the most comprehensive benefits. Available to those with incomes at or below 100% of the Federal Poverty Level (FPL), the QMB program covers virtually all Medicare cost-sharing obligations. Part B premiums, Part A premiums, if there are any, and any and all deductibles and co-insurance. QMB coverage is not retroactive.

    The program’s benefits will begin the month after the month in which your client is found eligible. ** See special rules about cost-sharing for QMBs below - updated with new CMS directive issued January 2012 ** See NYC HRA QMB Recertification form ** Even if you do not have Part A automatically, because you did not have enough wages, you may be able to enroll in the Part A Buy-In Program, in which people eligible for QMB who do not otherwise have Medicare Part A may enroll, with Medicaid paying the Part A premium (Materials by the Medicare Rights Center). 2. Specifiedl Low-Income Medicare Beneficiary (SLMB). For those with incomes between 100% and 120% FPL, the SLMB program will cover Part B premiums only.

    SLMB is retroactive, however, providing coverage for three months prior to the month of application, as long as your client was eligible during those months. 3. Qualified Individual (QI-1). For those with incomes between 120% and 135% FPL, and not receiving Medicaid, the QI-1 program will cover Medicare Part B premiums only. QI-1 is also retroactive, providing coverage for three months prior to the month of application, as long as your client was eligible during those months.

    However, QI-1 retroactive coverage can only be provided within the current calendar year. (GIS 07 MA 027) So if you apply in January, you get no retroactive coverage. Q-I-1 recipients would be eligible for Medicaid with a spend-down, but if they want the Part B premium paid, they must choose between enrolling in QI-1 or Medicaid. They cannot be in both. It is their choice.

    DOH MRG p. 19. In contrast, one may receive Medicaid and either QMB or SLIMB. 4. Four Special Benefits of MSPs (in addition to NO ASSET TEST).

    Benefit 1. Back Door to Medicare Part D "Extra Help" or Low Income Subsidy -- All MSP recipients are automatically enrolled in Extra Help, the subsidy that makes Part D affordable. They have no Part D deductible or doughnut hole, the premium is subsidized, and they pay very low copayments. Once they are enrolled in Extra Help by virtue of enrollment in an MSP, they retain Extra Help for the entire calendar year, even if they lose MSP eligibility during that year. The "Full" Extra Help subsidy has the same income limit as QI-1 - 135% FPL.

    However, many people may be eligible for QI-1 but not Extra Help because QI-1 and the other MSPs have no asset limit. People applying to the Social Security Administration for Extra Help might be rejected for this reason. Recent (2009-10) changes to federal law called "MIPPA" requires the Social Security Administration (SSA) to share eligibility data with NYSDOH on all persons who apply for Extra Help/ the Low Income Subsidy. Data sent to NYSDOH from SSA will enable NYSDOH to open MSP cases on many clients. The effective date of the MSP application must be the same date as the Extra Help application.

    Signatures will not be required from clients. In cases where the SSA data is incomplete, NYSDOH will forward what is collected to the local district for completion of an MSP application. The State implementing procedures are in DOH 2010 ADM-03. Also see CMS "Dear State Medicaid Director" letter dated Feb. 18, 2010 Benefit 2.

    MSPs Automatically Waive Late Enrollment Penalties for Part B Generally one must enroll in Part B within the strict enrollment periods after turning age 65 or after 24 months of Social Security Disability. An exception is if you or your spouse are still working and insured under an employer sponsored group health plan, or if you have End Stage Renal Disease, and other factors, see this from Medicare Rights Center. If you fail to enroll within those short periods, you might have to pay higher Part B premiums for life as a Late Enrollment Penalty (LEP). Also, you may only enroll in Part B during the Annual Enrollment Period from January 1 - March 31st each year, with Part B not effective until the following July. Enrollment in an MSP automatically eliminates such penalties...

    For life.. Even if one later ceases to be eligible for the MSP. AND enrolling in an MSP will automatically result in becoming enrolled in Part B if you didn't already have it and only had Part A. See Medicare Rights Center flyer. Benefit 3.

    No Medicaid Lien on Estate to Recover MSP Benefits Paid Generally speaking, states may place liens on the Estates of deceased Medicaid recipients to recover the cost of Medicaid services that were provided after the recipient reached the age of 55. Since 2002, states have not been allowed to recover the cost of Medicare premiums paid under MSPs. In 2010, Congress expanded protection for MSP benefits. Beginning on January 1, 2010, states may not place liens on the Estates of Medicaid recipients who died after January 1, 2010 to recover costs for co-insurance paid under the QMB MSP program for services rendered after January 1, 2010. The federal government made this change in order to eliminate barriers to enrollment in MSPs.

    See NYS DOH GIS 10-MA-008 - Medicare Savings Program Changes in Estate Recovery The GIS clarifies that a client who receives both QMB and full Medicaid is exempt from estate recovery for these Medicare cost-sharing expenses. Benefit 4. SNAP (Food Stamp) benefits not reduced despite increased income from MSP - at least temporarily Many people receive both SNAP (Food Stamp) benefits and MSP. Income for purposes of SNAP/Food Stamps is reduced by a deduction for medical expenses, which includes payment of the Part B premium. Since approval for an MSP means that the client no longer pays for the Part B premium, his/her SNAP/Food Stamps income goes up, so their SNAP/Food Stamps go down.

    Here are some protections. Do these individuals have to report to their SNAP worker that their out of pocket medical costs have decreased?. And will the household see a reduction in their SNAP benefits, since the decrease in medical expenses will increase their countable income?. The good news is that MSP households do NOT have to report the decrease in their medical expenses to the SNAP/Food Stamp office until their next SNAP/Food Stamp recertification. Even if they do report the change, or the local district finds out because the same worker is handling both the MSP and SNAP case, there should be no reduction in the household’s benefit until the next recertification.

    New York’s SNAP policy per administrative directive 02 ADM-07 is to “freeze” the deduction for medical expenses between certification periods. Increases in medical expenses can be budgeted at the household’s request, but NYS never decreases a household’s medical expense deduction until the next recertification. Most elderly and disabled households have 24-month SNAP certification periods. Eventually, though, the decrease in medical expenses will need to be reported when the household recertifies for SNAP, and the household should expect to see a decrease in their monthly SNAP benefit. It is really important to stress that the loss in SNAP benefits is NOT dollar for dollar.

    A $100 decrease in out of pocket medical expenses would translate roughly into a $30 drop in SNAP benefits. See more info on SNAP/Food Stamp benefits by the Empire Justice Center, and on the State OTDA website. Some clients will be automatically enrolled in an MSP by the New York State Department of Health (NYSDOH) shortly after attaining eligibility for Medicare. Others need to apply. The 2010 "MIPPA" law introduced some improvements to increase MSP enrollment.

    See 3rd bullet below. Also, some people who had Medicaid through the Affordable Care Act before they became eligible for Medicare have special procedures to have their Part B premium paid before they enroll in an MSP. See below. WHO IS AUTOMATICALLY ENROLLED IN AN MSP. Clients receiving even $1.00 of Supplemental Security Income should be automatically enrolled into a Medicare Savings Program (most often QMB) under New York State’s Medicare Savings Program Buy-in Agreement with the federal government once they become eligible for Medicare.

    They should receive Medicare Parts A and B. Clients who are already eligible for Medicare when they apply for Medicaid should be automatically assessed for MSP eligibility when they apply for Medicaid. (NYS DOH 2000-ADM-7 and GIS 05 MA 033). Clients who apply to the Social Security Administration for Extra Help, but are rejected, should be contacted &. Enrolled into an MSP by the Medicaid program directly under new MIPPA procedures that require data sharing.

    Strategy TIP. Since the Extra Help filing date will be assigned to the MSP application, it may help the client to apply online for Extra Help with the SSA, even knowing that this application will be rejected because of excess assets or other reason. SSA processes these requests quickly, and it will be routed to the State for MSP processing. Since MSP applications take a while, at least the filing date will be retroactive. Note.

    The above strategy does not work as well for QMB, because the effective date of QMB is the month after the month of application. As a result, the retroactive effective date of Extra Help will be the month after the failed Extra Help application for those with QMB rather than SLMB/QI-1. Applying for MSP Directly with Local Medicaid Program. Those who do not have Medicaid already must apply for an MSP through their local social services district. (See more in Section D.

    Below re those who already have Medicaid through the Affordable Care Act before they became eligible for Medicare. If you are applying for MSP only (not also Medicaid), you can use the simplified MSP application form (theDOH-4328(Rev. 8/2017-- English) (2017 Spanish version not yet available). Either application form can be mailed in -- there is no interview requirement anymore for MSP or Medicaid. See 10 ADM-04.

    Applicants will need to submit proof of income, a copy of their Medicare card (front &. Back), and proof of residency/address. See the application form for other instructions. One who is only eligible for QI-1 because of higher income may ONLY apply for an MSP, not for Medicaid too. One may not receive Medicaid and QI-1 at the same time.

    If someone only eligible for QI-1 wants Medicaid, s/he may enroll in and deposit excess income into a pooled Supplemental Needs Trust, to bring her countable income down to the Medicaid level, which also qualifies him or her for SLIMB or QMB instead of QI-1. Advocates in NYC can sign up for a half-day "Deputization Training" conducted by the Medicare Rights Center, at which you'll be trained and authorized to complete an MSP application and to submit it via the Medicare Rights Center, which submits it to HRA without the client having to apply in person. Enrolling in an MSP if you already have Medicaid, but just become eligible for Medicare Those who, prior to becoming enrolled in Medicare, had Medicaid through Affordable Care Act are eligible to have their Part B premiums paid by Medicaid (or the cost reimbursed) during the time it takes for them to transition to a Medicare Savings Program. In 2018, DOH clarified that reimbursement of the Part B premium will be made regardless of whether the individual is still in a Medicaid managed care (MMC) plan. GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare ( PDF) provides, "Due to efforts to transition individuals who gain Medicare eligibility and who require LTSS, individuals may not be disenrolled from MMC upon receipt of Medicare.

    To facilitate the transition and not disadvantage the recipient, the Medicaid program is approving reimbursement of Part B premiums for enrollees in MMC." The procedure for getting the Part B premium paid is different for those whose Medicaid was administered by the NYS of Health Exchange (Marketplace), as opposed to their local social services district. The procedure is also different for those who obtain Medicare because they turn 65, as opposed to obtaining Medicare based on disability. Either way, Medicaid recipients who transition onto Medicare should be automatically evaluated for MSP eligibility at their next Medicaid recertification. NYS DOH 2000-ADM-7 Individuals can also affirmatively ask to be enrolled in MSP in between recertification periods. IF CLIENT HAD MEDICAID ON THE MARKETPLACE (NYS of Health Exchange) before obtaining Medicare.

    IF they obtain Medicare because they turn age 65, they will receive a letter from their local district asking them to "renew" Medicaid through their local district. See 2014 LCM-02. Now, their Medicaid income limit will be lower than the MAGI limits ($842/ mo reduced from $1387/month) and they now will have an asset test. For this reason, some individuals may lose full Medicaid eligibility when they begin receiving Medicare. People over age 65 who obtain Medicare do NOT keep "Marketplace Medicaid" for 12 months (continuous eligibility) See GIS 15 MA/022 - Continuous Coverage for MAGI Individuals.

    Since MSP has NO ASSET limit. Some individuals may be enrolled in the MSP even if they lose Medicaid, or if they now have a Medicaid spend-down. If a Medicare/Medicaid recipient reports income that exceeds the Medicaid level, districts must evaluate the person’s eligibility for MSP. 08 OHIP/ADM-4 ​If you became eligible for Medicare based on disability and you are UNDER AGE 65, you are entitled to keep MAGI Medicaid for 12 months from the month it was last authorized, even if you now have income normally above the MAGI limit, and even though you now have Medicare. This is called Continuous Eligibility.

    EXAMPLE. Sam, age 60, was last authorized for Medicaid on the Marketplace in June 2016. He became enrolled in Medicare based on disability in August 2016, and started receiving Social Security in the same month (he won a hearing approving Social Security disability benefits retroactively, after first being denied disability). Even though his Social Security is too high, he can keep Medicaid for 12 months beginning June 2016. Sam has to pay for his Part B premium - it is deducted from his Social Security check.

    He may call the Marketplace and request a refund. This will continue until the end of his 12 months of continues MAGI Medicaid eligibility. He will be reimbursed regardless of whether he is in a Medicaid managed care plan. See GIS 18 MA/001 Medicaid Managed Care Transition for Enrollees Gaining Medicare (PDF) When that ends, he will renew Medicaid and apply for MSP with his local district. Individuals who are eligible for Medicaid with a spenddown can opt whether or not to receive MSP.

    (Medicaid Reference Guide (MRG) p. 19). Obtaining MSP may increase their spenddown. MIPPA - Outreach by Social Security Administration -- Under MIPPA, the SSA sends a form letter to people who may be eligible for a Medicare Savings Program or Extra Help (Low Income Subsidy - LIS) that they may apply. The letters are.

    · Beneficiary has Extra Help (LIS), but not MSP · Beneficiary has no Extra Help (LIS) or MSP 6. Enrolling in MSP for People Age 65+ who do Not have Free Medicare Part A - the "Part A Buy-In Program" Seniors WITHOUT MEDICARE PART A or B -- They may be able to enroll in the Part A Buy-In program, in which people eligible for QMB who are age 65+ who do not otherwise have Medicare Part A may enroll in Part A, with Medicaid paying the Part A premium. See Step-by-Step Guide by the Medicare Rights Center). This guide explains the various steps in "conditionally enrolling" in Part A at the SSA office, which must be done before applying for QMB at the Medicaid office, which will then pay the Part A premium. See also GIS 04 MA/013.

    In June, 2018, the SSA revised the POMS manual procedures for the Part A Buy-In to to address inconsistencies and confusion in SSA field offices and help smooth the path for QMB enrollment. The procedures are in the POMS Section HI 00801.140 "Premium-Free Part A Enrollments for Qualified Medicare BenefiIaries." It includes important clarifications, such as. SSA Field Offices should explain the QMB program and conditional enrollment process if an individual lacks premium-free Part A and appears to meet QMB requirements. SSA field offices can add notes to the “Remarks” section of the application and provide a screen shot to the individual so the individual can provide proof of conditional Part A enrollment when applying for QMB through the state Medicaid program. Beneficiaries are allowed to complete the conditional application even if they owe Medicare premiums.

    In Part A Buy-in states like NYS, SSA should process conditional applications on a rolling basis (without regard to enrollment periods), even if the application coincides with the General Enrollment Period. (The General Enrollment Period is from Jan 1 to March 31st every year, in which anyone eligible may enroll in Medicare Part A or Part B to be effective on July 1st). 7. What happens after the MSP approval - How is Part B premium paid For all three MSP programs, the Medicaid program is now responsible for paying the Part B premiums, even though the MSP enrollee is not necessarily a recipient of Medicaid. The local Medicaid office (DSS/HRA) transmits the MSP approval to the NYS Department of Health – that information gets shared w/ SSA and CMS SSA stops deducting the Part B premiums out of the beneficiary’s Social Security check.

    SSA also refunds any amounts owed to the recipient. (Note. This process can take awhile!. !. !.

    ) CMS “deems” the MSP recipient eligible for Part D Extra Help/ Low Income Subsidy (LIS). ​Can the MSP be retroactive like Medicaid, back to 3 months before the application?. ​The answer is different for the 3 MSP programs. QMB -No Retroactive Eligibility – Benefits begin the month after the month of the MSP application. 18 NYCRR § 360-7.8(b)(5) SLIMB - YES - Retroactive Eligibility up to 3 months before the application, if was eligible This means applicant may be reimbursed for the 3 months of Part B benefits prior to the month of application.

    What is lipitor taken for

    Elon Musk on Friday unveiled a what is lipitor taken for coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on YouTube to more than 150,000 viewers, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered in beeps and what is lipitor taken for bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head.

    YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that what is lipitor taken for in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia. The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development.

    Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose was to recruit potential new what is lipitor taken for employees. It was unclear whether the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere.

    Musk proceeded what is lipitor taken for to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the top of the skull. Neuralink’s technological design has changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the top what is lipitor taken for of the skull.

    After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up the lengthy regulatory process what is lipitor taken for — is a step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame.

    After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roader into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the Neuralink chip would allow people to summon their Tesla what is lipitor taken for telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future.

    Still, Musk what is lipitor taken for said. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017. At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals.

    Critically, the work did not show where in the brain the implanted electrodes were recording from, what is lipitor taken for for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday fell far short of that. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine what is lipitor taken for interfaces developed by academic labs and other companies.

    Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology. Neuralink said on Friday that its technology what is lipitor taken for would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing the event after more than 70 minutes, Musk said.

    €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”.

    Elon Musk on Friday unveiled a coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on YouTube to more than 150,000 viewers, the company staged a demonstration in which it trotted out a pig named lipitor cost per pill Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the lipitor cost per pill company’s brain implants in its head. YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a lipitor cost per pill regulatory pathway that could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia.

    The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development. Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose lipitor cost per pill was to recruit potential new employees. It was unclear whether the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere. Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit lipitor cost per pill snugly into the top of the skull.

    Neuralink’s technological design has changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several lipitor cost per pill wires stretching to the top of the skull. After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up the lengthy regulatory process — is a step forward, but it by no means guarantees lipitor cost per pill that a device will receive a green light, either in a short or longer-term time frame.

    After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roader into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the lipitor cost per pill Neuralink chip would allow people to summon their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future. Still, Musk said lipitor cost per pill. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017.

    At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals. Critically, the work did not show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk lipitor cost per pill spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday fell far short of that. Neuralink’s prototype lipitor cost per pill is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies. Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology.

    Neuralink said lipitor cost per pill on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing the event after more than 70 minutes, Musk said. €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”.

    Can i take lipitor every other day

    Aug. 29, 2020 -- Chadwick Boseman, the star of the 2018 Marvel Studios megahit Black Panther, died of colon cancer Friday. He was 43.

    Boseman, who was diagnosed 4 years ago, had kept his condition a secret. He filmed his recent movies ''during and between countless surgeries and chemotherapy," according to a statement issued on his Twitter account. When the actor was diagnosed in 2016, the cancer was at stage III -- meaning it had already grown through the colon wall -- but then progressed to the more lethal stage IV, meaning it had spread beyond his colon.

    Messages of condolences and the hashtag #Wakandaforever, referring to the fictional African nation in the Black Panther film, flooded social media Friday evening. Oprah tweeted. "What a gentle gifted SOUL.

    Showing us all that Greatness in between surgeries and chemo. The courage, the strength, the Power it takes to do that. This is what Dignity looks like.

    " Marvel Studios tweeted. "Your legacy will live on forever." Boseman was also known for his role as Jackie Robinson in the movie 42. Coincidentally, Friday was Major League Baseball's Jackie Robinson Day, where every player on every team wears Robinson's number 42 on their jerseys.

    Boseman's other starring roles include portraying James Brown in Get on Up and U.S. Supreme Court Justice Thurgood Marshall in Marshall. But his role as King T'Challa in Black Panther, the super hero protagonist, made him an icon and an inspiration.

    About Colon Cancer Boseman's death reflects a troubling recent trend, says Mark Hanna, MD, a colorectal surgeon at City of Hope, a comprehensive cancer center near Los Angeles. "We have noticed an increasing incidence of colorectal cancer in young adults," says Hanna, who did not treat Boseman. "I've seen patients as young as their early 20s." About 104,000 cases of colon cancer will be diagnosed this year, according to American Cancer Society estimates, and another 43,000 cases of rectal cancer will be diagnosed.

    About 12% of those, or 18,000 cases, will be in people under age 50. As the rates have declined in older adults due to screening, rates in young adults have steadily risen. Younger patients are often diagnosed at a later stage than older adults, Hanna says, because patients and even their doctors don't think about the possibility of colon cancer.

    Because it is considered a cancer affecting older adults, many younger people may brush off the symptoms or delay getting medical attention, Hanna says. In a survey of 885 colorectal cancer patients conducted by Colorectal Cancer Alliance earlier this year, 75% said they visited two or more doctors before getting their diagnosis, and 11% went to 10 or more before finding out. If found early, colon cancer is curable, Hanna says.

    About 50% of those with colon cancer will be diagnosed at stage I or II, which is considered localized disease, he says. "The majority have a very good prognosis." The 5-year survival rate is about 90% for both stage I and II. But when it progresses to stage III, the cancer has begun to grow into surrounding tissues and the lymph nodes, Hanna says, and the survival rate for 5 years drops to 75%.

    About 25% of patients are diagnosed at stage III, he says. If the diagnosis is made at stage IV, the 5-year survival rate drops to about 10% or 15%, he says. Experts have been trying to figure out why more young adults are getting colon cancer and why some do so poorly.

    "Traditionally we thought that patients who are older would have a worse outlook," Hanna says, partly because they tend to have other medical conditions too. Some experts say that younger patients might have more ''genetically aggressive disease," Hanna says. "Our understanding of colorectal cancer is becoming more nuanced, and we know that not all forms are the same." For instance, he says, testing is done for specific genetic mutations that have been tied to colon cancer.

    "It's not just about finding the mutations, but finding the drug that targets [that form] best." Paying Attention to Red Flags "If you have any of what we call the red flag signs, do not ignore your symptoms no matter what your age is," Hanna says. Those are. In 2018, the American Cancer Society changed its guidelines for screening, recommending those at average risk start at age 45, not 50.

    The screening can be stool-based testing, such as a fecal occult blood test, or visual, such as a colonoscopy. Hanna says he orders a colonoscopy if the symptoms suggest colon cancer, regardless of a patient's age. Family history of colorectal cancer is a risk factor, as are being obese or overweight, being sedentary, and eating lots of red meat.

    Sources Mark Hanna, MD, colorectal surgeon and assistant clinical professor of surgery, City of Hope, Los Angeles. American Cancer Society. "Key Statistics for Colorectal Cancer." Twitter statement.

    Chadwick Boseman. American Cancer Society. "Colorectal Cancer Risk Factors." American Cancer Society.

    '"Colorectal Cancer Rates Rise in Younger Adults." American Society of Clinical Oncology annual meeting, May 29-31, 2020. American Cancer Society "Survival Rates for Colorectal Cancer." American Cancer Society. "Colorectal Cancer Facts &.

    Figures. 2017-2019." © 2020 WebMD, LLC. All rights reserved.FRIDAY, Aug.

    28, 2020 (HealthDay News) -- As many as 20% of Americans don't believe in vaccines, a new study finds. Misinformed vaccine beliefs drive opposition to public vaccine policies even more than politics, education, religion or other factors, researchers say. The findings are based on a survey of nearly 2,000 U.S.

    Adults done in 2019, during the largest measles outbreak in 25 years. The researchers, from the Annenberg Public Policy Center (APPC) of the University of Pennsylvania, found that negative misperceptions about vaccinations. reduced the likelihood of supporting mandatory childhood vaccines by 70%, reduced the likelihood of opposing religious exemptions by 66%, reduced the likelihood of opposing personal belief exemptions by 79%.

    "There are real implications here for a vaccine for COVID-19," lead author Dominik Stecula said in an APPC news release. He conducted the research while at APPC and is now an assistant professor of political science at Colorado State University. "The negative vaccine beliefs we examined aren't limited only to the measles, mumps and rubella [MMR] vaccine, but are general attitudes about vaccination." Stecula called for an education campaign by public health professionals and journalists, among others, to preemptively correct misinformation and prepare the public to accept a COVID-19 vaccine.

    Overall, there was strong support for vaccination policies. 72% strongly or somewhat supported mandatory childhood vaccination, 60% strongly or somewhat opposed religious exemptions, 66% strongly or somewhat opposed vaccine exemptions based on personal beliefs. "On the one hand, these are big majorities.

    Well above 50% of Americans support mandatory childhood vaccinations and oppose religious and personal belief exemptions to vaccination," said co-author Ozan Kuru, a former APPC researcher, now an assistant professor of communications at the National University of Singapore. "Still, we need a stronger consensus in the public to bolster pro-vaccine attitudes and legislation and thus achieve community immunity," he added in the release. A previous study from the 2018-2019 measles outbreak found that people who rely on social media were more likely to be misinformed about vaccines.

    And a more recent one found that people who got information from social media or conservative news outlets at the start of the COVID-19 pandemic were more likely to be misinformed about how to prevent infection and hold conspiracy theories about it. With the coronavirus pandemic still raging, the number of Americans needed to be vaccinated to achieve community-wide immunity is not known, the researchers said. The findings were recently published online in the American Journal of Public Health.By Robert Preidt HealthDay Reporter FRIDAY, Aug.

    28, 2020 (HealthDay News) -- Breastfeeding mothers are unlikely to transmit the new coronavirus to their babies via their milk, researchers say. No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain. Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19.

    One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant, according to the study recently published online in the Journal of the American Medical Association. "Detection of viral RNA does not equate to infection. It has to grow and multiply in order to be infectious and we did not find that in any of our samples," said study author Christina Chambers, a professor of pediatrics at the University of California, San Diego.

    She is also director of the Mommy's Milk Human Milk Research Biorepository. "Our findings suggest breast milk itself is not likely a source of infection for the infant," Chambers said in a UCSD news release. To prevent transmission of the virus while breastfeeding, wearing a mask, hand-washing and sterilizing pumping equipment after each use are recommended.

    "We hope our results and future studies will give women the reassurance needed for them to breastfeed. Human milk provides invaluable benefits to mom and baby," said co-author Dr. Grace Aldrovandi, chief of the Division of Infectious Diseases at UCLA Mattel Children's Hospital in Los Angeles.

    WebMD News from HealthDay Sources SOURCE. University of California, San Diego, news release, Aug. 19, 2020 Copyright © 2013-2020 HealthDay.

    All rights reserved.Nursing home staff will have to be tested regularly for COVID-19, and facilities that fail to do so will face fines, the Trump administration said Tuesday. Even though they account for less than 1% of the nation's population, long-term care facilities account for 42% of COVID-19 deaths in the United States, the Associated Press reported. There have been more than 70,000 deaths in U.S.

    Nursing homes, according to the COVID Tracking Project. It's been months since the White House first urged governors to test all nursing home residents and staff, the AP reported. WebMD News from HealthDay Copyright © 2013-2020 HealthDay.

    All rights reserved.August 28, 2020 -- Alcohol-based hand sanitizers that are packaged in containers that look like food items or drinks could cause injury or death if ingested, according to a new warning the FDA issued Thursday. Hand sanitizers are being packaged in beer cans, water bottles, juice bottles, vodka bottles and children’s food pouches, the FDA said. Some sanitizers also contain flavors, such as chocolate or raspberry, which could cause confusion.

    €œI am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages,” Stephen Hahn, MD, the FDA commissioner, said in a statement. Accidentally drinking hand sanitizer — even a small amount — is potentially lethal to children. €œThese products could confuse consumers into accidentally ingesting a potentially deadly product,” he said.

    €œIt’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning.” For example, the FDA received a report about a consumer who purchased a bottle that looked like drinkable water but was actually hand sanitizer. In another report, a retailer informed the agency about a hand sanitizer product that was marketed in a pouch that looks like a children’s snack and had cartoons on it. Meanwhile, the FDA's warning list about dangerous hand sanitizers containing methanol continues to grow as some people are drinking the sanitizers to get an alcohol high.

    Others have believed a rumor, circulated online, that drinking the highly potent and toxic alcohol can disinfect the body, protecting them from COVID-19 infection. Earlier this month, the FDA also issued a warning about hand sanitizers contaminated with 1-propanol. Ingesting 1-propanol can cause central nervous system depression, which can be fatal, the agency says.

    Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. One brand of sanitizer, Harmonic Nature S de RL de MI of Mexico, are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. Poison control centers and state health departments have reported an increasing number of adverse events associated with hand sanitizer ingestion, including heart issues, nervous system problems, hospitalizations and deaths, according to the statement.

    The FDA encouraged consumers and health care professionals to report issues to the MedWatch Adverse Event Reporting program. The agency is working with manufacturers to recall confusing and dangerous products and is encouraging retailers to remove some products from shelves. The FDA is also updating its list of hand sanitizer products that consumers should avoid.

    €œManufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers,” Hahn said..

    Aug. 29, 2020 -- Chadwick Boseman, the star of the 2018 Marvel Studios megahit Black Panther, died of colon cancer Friday. He was 43.

    Boseman, who was diagnosed 4 years ago, had kept his condition a secret. He filmed his recent movies ''during and between countless surgeries and chemotherapy," according to a statement issued on his Twitter account. When the actor was diagnosed in 2016, the cancer was at stage III -- meaning it had already grown through the colon wall -- but then progressed to the more lethal stage IV, meaning it had spread beyond his colon.

    Messages of condolences and the hashtag #Wakandaforever, referring to the fictional African nation in the Black Panther film, flooded social media Friday evening. Oprah tweeted. "What a gentle gifted SOUL.

    Showing us all that Greatness in between surgeries and chemo. The courage, the strength, the Power it takes to do that. This is what Dignity looks like.

    " Marvel Studios tweeted. "Your legacy will live on forever." Boseman was also known for his role as Jackie Robinson in the movie 42. Coincidentally, Friday was Major League Baseball's Jackie Robinson Day, where every player on every team wears Robinson's number 42 on their jerseys.

    Boseman's other starring roles include portraying James Brown in Get on Up and U.S. Supreme Court Justice Thurgood Marshall in Marshall. But his role as King T'Challa in Black Panther, the super hero protagonist, made him an icon and an inspiration.

    About Colon Cancer Boseman's death reflects a troubling recent trend, says Mark Hanna, MD, a colorectal surgeon at City of Hope, a comprehensive cancer center near Los Angeles. "We have noticed an increasing incidence of colorectal cancer in young adults," says Hanna, who did not treat Boseman. "I've seen patients as young as their early 20s." About 104,000 cases of colon cancer will be diagnosed this year, according to American Cancer Society estimates, and another 43,000 cases of rectal cancer will be diagnosed.

    About 12% of those, or 18,000 cases, will be in people under age 50. As the rates have declined in older adults due to screening, rates in young adults have steadily risen. Younger patients are often diagnosed at a later stage than older adults, Hanna says, because patients and even their doctors don't think about the possibility of colon cancer.

    Because it is considered a cancer affecting older adults, many younger people may brush off the symptoms or delay getting medical attention, Hanna says. In a survey of 885 colorectal cancer patients conducted by Colorectal Cancer Alliance earlier this year, 75% said they visited two or more doctors before getting their diagnosis, and 11% went to 10 or more before finding out. If found early, colon cancer is curable, Hanna says.

    About 50% of those with colon cancer will be diagnosed at stage I or II, which is considered localized disease, he says. "The majority have a very good prognosis." The 5-year survival rate is about 90% for both stage I and II. But when it progresses to stage III, the cancer has begun to grow into surrounding tissues and the lymph nodes, Hanna says, and the survival rate for 5 years drops to 75%.

    About 25% of patients are diagnosed at stage III, he says. If the diagnosis is made at stage IV, the 5-year survival rate drops to about 10% or 15%, he says. Experts have been trying to figure out why more young adults are getting colon cancer and why some do so poorly.

    "Traditionally we thought that patients who are older would have a worse outlook," Hanna says, partly because they tend to have other medical conditions too. Some experts say that younger patients might have more ''genetically aggressive disease," Hanna says. "Our understanding of colorectal cancer is becoming more nuanced, and we know that not all forms are the same." For instance, he says, testing is done for specific genetic mutations that have been tied to colon cancer.

    "It's not just about finding the mutations, but finding the drug that targets [that form] best." Paying Attention to Red Flags "If you have any of what we call the red flag signs, do not ignore your symptoms no matter what your age is," Hanna says. Those are. In 2018, the American Cancer Society changed its guidelines for screening, recommending those at average risk start at age 45, not 50.

    The screening can be stool-based testing, such as a fecal occult blood test, or visual, such as a colonoscopy. Hanna says he orders a colonoscopy if the symptoms suggest colon cancer, regardless of a patient's age. Family history of colorectal cancer is a risk factor, as are being obese or overweight, being sedentary, and eating lots of red meat.

    Sources Mark Hanna, MD, colorectal surgeon and assistant clinical professor of surgery, City of Hope, Los Angeles. American Cancer Society. "Key Statistics for Colorectal Cancer." Twitter statement.

    Chadwick Boseman. American Cancer Society. "Colorectal Cancer Risk Factors." American Cancer Society.

    '"Colorectal Cancer Rates Rise in Younger Adults." American Society of Clinical Oncology annual meeting, May 29-31, 2020. American Cancer Society "Survival Rates for Colorectal Cancer." American Cancer Society. "Colorectal Cancer Facts &.

    Figures. 2017-2019." © 2020 WebMD, LLC. All rights reserved.FRIDAY, Aug.

    28, 2020 (HealthDay News) -- As many as 20% of Americans don't believe in vaccines, a new study finds. Misinformed vaccine beliefs drive opposition to public vaccine policies even more than politics, education, religion or other factors, researchers say. The findings are based on a survey of nearly 2,000 U.S.

    Adults done in 2019, during the largest measles outbreak in 25 years. The researchers, from the Annenberg Public Policy Center (APPC) of the University of Pennsylvania, found that negative misperceptions about vaccinations. reduced the likelihood of supporting mandatory childhood vaccines by 70%, reduced the likelihood of opposing religious exemptions by 66%, reduced the likelihood of opposing personal belief exemptions by 79%.

    "There are real implications here for a vaccine for COVID-19," lead author Dominik Stecula said in an APPC news release. He conducted the research while at APPC and is now an assistant professor of political science at Colorado State University. "The negative vaccine beliefs we examined aren't limited only to the measles, mumps and rubella [MMR] vaccine, but are general attitudes about vaccination." Stecula called for an education campaign by public health professionals and journalists, among others, to preemptively correct misinformation and prepare the public to accept a COVID-19 vaccine.

    Overall, there was strong support for vaccination policies. 72% strongly or somewhat supported mandatory childhood vaccination, 60% strongly or somewhat opposed religious exemptions, 66% strongly or somewhat opposed vaccine exemptions based on personal beliefs. "On the one hand, these are big majorities.

    Well above 50% of Americans support mandatory childhood vaccinations and oppose religious and personal belief exemptions to vaccination," said co-author Ozan Kuru, a former APPC researcher, now an assistant professor of communications at the National University of Singapore. "Still, we need a stronger consensus in the public to bolster pro-vaccine attitudes and legislation and thus achieve community immunity," he added in the release. A previous study from the 2018-2019 measles outbreak found that people who rely on social media were more likely to be misinformed about vaccines.

    And a more recent one found that people who got information from social media or conservative news outlets at the start of the COVID-19 pandemic were more likely to be misinformed about how to prevent infection and hold conspiracy theories about it. With the coronavirus pandemic still raging, the number of Americans needed to be vaccinated to achieve community-wide immunity is not known, the researchers said. The findings were recently published online in the American Journal of Public Health.By Robert Preidt HealthDay Reporter FRIDAY, Aug.

    28, 2020 (HealthDay News) -- Breastfeeding mothers are unlikely to transmit the new coronavirus to their babies via their milk, researchers say. No cases of an infant contracting COVID-19 from breast milk have been documented, but questions about the potential risk remain. Researchers examined 64 samples of breast milk collected from 18 women across the United States who were infected with the new coronavirus (SARS-CoV-2) that causes COVID-19.

    One sample tested positive for coronavirus RNA, but follow-up tests showed that the virus couldn't replicate and therefore, couldn't infect the breastfed infant, according to the study recently published online in the Journal of the American Medical Association. "Detection of viral RNA does not equate to infection. It has to grow and multiply in order to be infectious and we did not find that in any of our samples," said study author Christina Chambers, a professor of pediatrics at the University of California, San Diego.

    She is also director of the Mommy's Milk Human Milk Research Biorepository. "Our findings suggest breast milk itself is not likely a source of infection for the infant," Chambers said in a UCSD news release. To prevent transmission of the virus while breastfeeding, wearing a mask, hand-washing and sterilizing pumping equipment after each use are recommended.

    "We hope our results and future studies will give women the reassurance needed for them to breastfeed. Human milk provides invaluable benefits to mom and baby," said co-author Dr. Grace Aldrovandi, chief of the Division of Infectious Diseases at UCLA Mattel Children's Hospital in Los Angeles.

    WebMD News from HealthDay Sources SOURCE. University of California, San Diego, news release, Aug. 19, 2020 Copyright © 2013-2020 HealthDay.

    All rights reserved.Nursing home staff will have to be tested regularly for COVID-19, and facilities that fail to do so will face fines, the Trump administration said Tuesday. Even though they account for less than 1% of the nation's population, long-term care facilities account for 42% of COVID-19 deaths in the United States, the Associated Press reported. There have been more than 70,000 deaths in U.S.

    Nursing homes, according to the COVID Tracking Project. It's been months since the White House first urged governors to test all nursing home residents and staff, the AP reported. WebMD News from HealthDay Copyright © 2013-2020 HealthDay.

    All rights reserved.August 28, 2020 -- Alcohol-based hand sanitizers that are packaged in containers that look like food items or drinks could cause injury or death if ingested, according to a new warning the FDA issued Thursday. Hand sanitizers are being packaged in beer cans, water bottles, juice bottles, vodka bottles and children’s food pouches, the FDA said. Some sanitizers also contain flavors, such as chocolate or raspberry, which could cause confusion.

    €œI am increasingly concerned about hand sanitizer being packaged to appear to be consumable products, such as baby food or beverages,” Stephen Hahn, MD, the FDA commissioner, said in a statement. Accidentally drinking hand sanitizer — even a small amount — is potentially lethal to children. €œThese products could confuse consumers into accidentally ingesting a potentially deadly product,” he said.

    €œIt’s dangerous to add scents with food flavors to hand sanitizers which children could think smells like food, eat and get alcohol poisoning.” For example, the FDA received a report about a consumer who purchased a bottle that looked like drinkable water but was actually hand sanitizer. In another report, a retailer informed the agency about a hand sanitizer product that was marketed in a pouch that looks like a children’s snack and had cartoons on it. Meanwhile, the FDA's warning list about dangerous hand sanitizers containing methanol continues to grow as some people are drinking the sanitizers to get an alcohol high.

    Others have believed a rumor, circulated online, that drinking the highly potent and toxic alcohol can disinfect the body, protecting them from COVID-19 infection. Earlier this month, the FDA also issued a warning about hand sanitizers contaminated with 1-propanol. Ingesting 1-propanol can cause central nervous system depression, which can be fatal, the agency says.

    Symptoms of 1-propanol exposure can include confusion, decreased consciousness, and slowed pulse and breathing. One brand of sanitizer, Harmonic Nature S de RL de MI of Mexico, are labeled to contain ethanol or isopropyl alcohol but have tested positive for 1-propanol contamination. Poison control centers and state health departments have reported an increasing number of adverse events associated with hand sanitizer ingestion, including heart issues, nervous system problems, hospitalizations and deaths, according to the statement.

    The FDA encouraged consumers and health care professionals to report issues to the MedWatch Adverse Event Reporting program. The agency is working with manufacturers to recall confusing and dangerous products and is encouraging retailers to remove some products from shelves. The FDA is also updating its list of hand sanitizer products that consumers should avoid.

    €œManufacturers should be vigilant about packaging and marketing their hand sanitizers in food or drink packages in an effort to mitigate any potential inadvertent use by consumers,” Hahn said..

  • Lipitor blood pressure

    Où rencontrer Pasteur dans Dole

    A la façon du Circuit du Chat Perché qui permet de découvrir les sites les plus attractifs de Dole, Alain Marchal nous propose de déambuler dans certains lieux publics dolois...pour admirer statues, fresques trompe-l’œil, mosaïques ou bustes à l'effigie...

    > LIRE LA SUITE

  • Lipitor blood pressure

    Où rencontrer Pasteur dans Dole

    A la façon du Circuit du Chat Perché qui permet de découvrir les sites les plus attractifs de Dole, Alain Marchal nous propose de déambuler dans certains lieux publics dolois...pour admirer statues, fresques trompe-l’œil, mosaïques ou bustes à l'effigie...

    > LIRE LA SUITE

  • Lipitor blood pressure

    Visite passion

    Pendant les vacances , venez faire la connaissance de Louis PASTEUR, visitez sa maison natale à Dole et la salle scientifique exposant les découvertes de notre grand savant Jurassien.
    Les bénévoles des Amis de PASTEUR vous proposent une "visite passion...

    > LIRE LA SUITE

  • Lipitor blood pressure

    Visite passion

    Pendant les vacances , venez faire la connaissance de Louis PASTEUR, visitez sa maison natale à Dole et la salle scientifique exposant les découvertes de notre grand savant Jurassien.
    Les bénévoles des Amis de PASTEUR vous proposent une "visite passion...

    > LIRE LA SUITE

  • Lipitor blood pressure

    Louis Pasteur et le ver à soie :


    Une exposition présentera à la Maison natale des aspects actuels de l'utilisation de la soie, dans les domaines industriels et techniques, dans la création artistique, avec un clin d'oeil aux travaux de Pasteur sur les maladies des vers à soie en...

    > LIRE LA SUITE

  • Lipitor blood pressure

    Visite passion

    Pendant les vacances , venez faire la connaissance de Louis PASTEUR, visitez sa maison natale à Dole et la salle scientifique exposant les découvertes de notre grand savant Jurassien.
    Les bénévoles des Amis de PASTEUR vous proposent une "visite passion...

    > LIRE LA SUITE