How the F.D.A. Stood Up to the President

After months of caving to pressures from the White House, Commissioner Stephen Hahn and a band of agency scientists have eked out a few victories.

#clinical-trials, #coronavirus-2019-ncov, #hahn-stephen-m-1960, #health-and-human-services-department, #regulation-and-deregulation-of-industry, #science-and-technology, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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Covid-19 and Beyond: How Trump Has Hurt America’s Health

Downplaying the dangers of the pandemic and politicizing public health measures was grossly negligent and cost untold lives.

#appointments-and-executive-changes, #biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #environmental-protection-agency, #food-and-drug-administration, #greenhouse-gas-emissions, #hahn-stephen-m-1960, #new-england-journal-of-medicine, #politics-and-government, #presidential-election-of-2020, #redfield-robert-r, #science-and-technology, #trump-donald-j

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Can Trump Really Speed Approval of Covid Treatments?

Emergency-use authorizations, a formerly obscure corner of regulatory law, have become a centerpiece of the government’s response to the pandemic.

#clinical-trials, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #vaccination-and-immunization, #your-feed-health, #your-feed-healthcare, #your-feed-science

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White House Blocks New Coronavirus Vaccine Guidelines

The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.

#azar-alex-m-ii, #clinical-trials, #coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #meadows-mark-r-1959, #office-of-management-and-budget-us, #regulation-and-deregulation-of-industry, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization, #your-feed-healthcare

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Trump Pressed for a Plasma Treatment. Officials Worry, Is a Vaccine Next?

New details of how the president has demanded faster action from health agencies help explain the intensifying concern that he could demand pre-Election Day approval of a vaccine.

#azar-alex-m-ii, #birx-deborah-l, #blood, #clinical-trials, #collins-francis-s, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #kushner-jared, #marks-peter, #mayo-clinic, #meadows-mark-r-1959, #national-institutes-of-health, #presidential-election-of-2020, #republican-national-convention, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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F.D.A. Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure

A group of career scientists at the Food and Drug Administration vowed that their work would continue unimpeded and independent of political influence.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government

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Emily Miller and Another P.R. Expert Ousted At F.D.A. After Blood Plasma Fiasco

The agency’s chief spokeswoman, Emily Miller, was removed from her position just 11 days into the job. And the contract was terminated of a consultant who had advised the F.D.A. chief to correct misleading claims about plasma’s benefits.

#apco-worldwide, #appointments-and-executive-changes, #azar-alex-m-ii, #blood, #convalescent-plasma, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #miller-emily-j, #pines-wayne-l, #trump-donald-j, #vaccination-and-immunization

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The F.D.A. Commissioner’s Fuzzy Math

Stephen Hahn made misleading remarks about a coronavirus treatment. How did that happen?

#coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #national-institutes-of-health, #united-states, #vaccination-and-immunization

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F.D.A. ‘Grossly Misrepresented’ Blood Plasma Data, Scientists Say

Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about where a key statistic came from.

#azar-alex-m-ii, #clinical-trials, #convalescent-plasma, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #hahn-stephen-m-1960, #marks-peter, #trump-donald-j, #united-states-politics-and-government

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Politicizing Medical Science Will Cost American Lives

Sowing doubt about the safety of treatments will imperil the fight against coronavirus in the months and years to come.

#centers-for-disease-control-and-prevention, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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F.D.A. Allows Expanded Use of Convalescent Plasma to Treat Coronavirus Patients

The move came on the eve of the Republican convention and after President Trump pressed the agency to move faster to address the pandemic.

#blood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #marks-peter, #trump-donald-j, #united-states-politics-and-government

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Stephen Hahn, F.D.A. Chief, Is Caught Between Scientists and the President

Many medical experts — including members of his own staff — worry about whether Dr. Hahn has the fortitude and political savvy to protect the scientific integrity of the F.D.A. from Mr. Trump.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #tests-medical, #united-states-politics-and-government, #vaccination-and-immunization

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Health Experts to F.D.A.: Make Your Vaccine Deliberations Public

A letter signed by nearly 400 health experts asked the agency to use its vaccine advisory panel when reviewing data on coronavirus trials.

#clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #hahn-stephen-m-1960, #medicine-and-health, #vaccination-and-immunization

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As Trump Praises Plasma, Researchers Struggle to Finish Critical Studies

Thousands of Covid-19 patients have been treated with blood plasma outside of rigorous clinical trials — hampering research that would have shown whether the therapy worked.

#american-red-cross, #blood-donation, #brigham-and-womens-hospital, #clinical-trials, #columbia-university, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #epidemics, #food-and-drug-administration, #guerrero-elliott-bennett, #hahn-stephen-m-1960, #health-and-human-services-department, #hospitals, #johnson-dwayne-1972, #lipkin-w-ian, #mayo-clinic, #medicine-and-health, #research, #trump-donald-j, #your-feed-science

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Does Blood Plasma Work for Covid-19 Patients? No One Knows.

Thousands of Covid-19 patients have been treated with blood plasma outside of rigorous clinical trials — hampering research that would have showed whether the therapy worked.

#american-red-cross, #blood-donation, #brigham-and-womens-hospital, #clinical-trials, #columbia-university, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #epidemics, #food-and-drug-administration, #guerrero-elliott-bennett, #hahn-stephen-m-1960, #health-and-human-services-department, #hospitals, #johnson-dwayne-1972, #lipkin-w-ian, #mayo-clinic, #medicine-and-health, #research, #trump-donald-j, #your-feed-science

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Scientists Worry About Political Influence Over Coronavirus Vaccine Project

Operation Warp Speed has moved along at a rapid clip. But some people involved in the approval process fear pressure to deliver an October surprise for President Trump.

#appointments-and-executive-changes, #azar-alex-m-ii, #birx-deborah-l, #clinical-trials, #conflicts-of-interest, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #fauci-anthony-s, #food-and-drug-administration, #hahn-stephen-m-1960, #health-and-human-services-department, #kushner-jared, #medicine-and-health, #moderna-inc, #polls-and-public-opinion, #presidential-election-of-2020, #public-private-sector-cooperation, #regulation-and-deregulation-of-industry, #slaoui-moncef-m, #trump-donald-j, #united-states-politics-and-government, #vaccination-and-immunization

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Top Science and Health Officials Offer Sobering View of Reopening Readiness

Despite progress on a vaccine, there is no guarantee it will be effective, experts said, and testing and contact tracing are still short of the levels needed.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #epidemics, #fauci-anthony-s, #food-and-drug-administration, #giroir-brett-p, #hahn-stephen-m-1960, #medicine-and-health, #paul-rand, #quarantines, #redfield-robert-r, #senate-committee-on-health-education-labor-and-pensions, #shutdowns-institutional, #tests-medical, #united-states-politics-and-government, #vaccination-and-immunization

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White House Orders Staff to Wear Masks as Trump Misrepresents Testing Record

At a news conference, the president reiterated that he would not wear a mask himself and again exaggerated the availability of testing for the coronavirus.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #defense-department, #fauci-anthony-s, #hahn-stephen-m-1960, #masks, #miller-katie-rose, #pence-mike, #redfield-robert-r, #tests-medical, #trump-donald-j, #united-states-politics-and-government, #white-house-building-washington-dc

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Fauci, Other Witnesses and Chairman Are Quarantined, but Hearing Must Go On

Tuesday’s hearing before the Senate Health Committee will be a chance for Dr. Anthony S. Fauci and other top health experts to speak to lawmakers, albeit by video, without President Trump nearby.

#alexander-lamar, #coronavirus-2019-ncov, #fauci-anthony-s, #giroir-brett-p, #hahn-stephen-m-1960, #quarantines, #redfield-robert-r, #senate, #trump-donald-j, #united-states-politics-and-government

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F.D.A. Warns of Heart Problems From Malaria Drugs Used for Coronavirus

The drugs, hydroxychloroquine and chloroquine, have been repeatedly promoted by President Trump. But they should be used only in clinical trials or hospitals, the agency said.

#azithromycin-drug, #biomedical-advanced-research-and-development-authority, #bright-rick-a, #chloroquine-drug, #coronavirus-2019-ncov, #food-and-drug-administration, #hahn-stephen-m-1960, #hydroxychloroquine-drug, #national-institute-of-allergy-and-infectious-diseases, #nature-medicine-journal, #nyu-langone-health, #trump-donald-j, #your-feed-healthcare

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The Lost Month: How a Failure to Test Blinded the U.S. to Covid-19

Aggressive screening might have helped contain the coronavirus in the United States. But technical flaws, regulatory hurdles and lapses in leadership let it spread undetected for weeks.

#azar-alex-m-ii, #biofire-defense-llc, #centers-for-disease-control-and-prevention, #china, #chinese-centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #fauci-anthony-s, #food-and-drug-administration, #giroir-brett-p, #hahn-stephen-m-1960, #health-and-human-services-department, #medicine-and-health, #national-center-for-immunization-and-respiratory-diseases, #pence-mike, #qiagen-nv, #quarantines, #redfield-robert, #regulation-and-deregulation-of-industry, #sars-severe-acute-respiratory-syndrome, #tests-medical, #united-states, #united-states-politics-and-government, #white-house-building-washington-dc, #world-health-organization

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With Minimal Evidence, Trump Asks F.D.A. to Study Malaria Drugs for Coronavirus

The president cites “tremendous promise” for existing drugs, but their use against the new virus is unproven.

#american-society-of-health-system-pharmacists, #bayer-ag, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #gilead-sciences-inc, #hahn-stephen-m-1960, #trump-donald-j, #united-states-politics-and-government, #your-feed-healthcare

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