Biden’s Pandemic Fight: Inside the Setbacks of the First Year

The administration has gotten much right, but its response has been hampered by confusing messaging, a lack of focus on testing, fear of political blowback and the coronavirus’s unpredictability.

#biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-omicron-variant, #fauci-anthony-s, #food-and-drug-administration, #health-and-human-services-department, #masks, #presidents-and-presidency-us, #tests-medical, #united-states-politics-and-government, #vaccination-and-immunization, #walensky-rochelle, #woodcock-janet

How Being Sick Changed My Health Care Views

A chronic illness made me more left-wing and more libertarian at once.

#bankruptcies, #centers-for-disease-control-and-prevention, #food-and-drug-administration, #great-britain, #health-insurance-and-managed-care, #independent-payment-advisory-board, #innovation, #lyme-disease, #medicaid, #multiple-sclerosis, #patient-protection-and-affordable-care-act-2010, #united-states

The C.D.C. and F.D.A. Can Work Better Together

Among the agencies’ major challenges during the pandemic has been collaboration.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #food-and-drug-administration

Detainees Sue Arkansas Jail That Gave Them Ivermectin to Treat Covid

For months, the jail’s doctor has promoted the drug, which health experts say should not be used to treat or prevent Covid-19.

#american-civil-liberties-union, #arkansas, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #ivermectin-drug, #suits-and-litigation-civil, #washington-county

What the Supreme Court’s Vaccine Case Was Really About

The justices are turning around long-established law giving government agencies running room to do their jobs.

#coronavirus-2019-ncov, #coronavirus-return-to-office, #courts-and-the-judiciary, #food-and-drug-administration, #labor-and-jobs, #occupational-safety-and-health-administration, #regulation-and-deregulation-of-industry, #republican-party, #supreme-court-us, #united-states-politics-and-government, #vaccination-and-immunization, #workplace-hazards-and-violations

Senate Panel OKs Califf Nomination for F.D.A. Chief

A key committee was split mainly on party lines over the nomination of Dr. Robert Califf, foreshadowing divisions in the full Senate for a vote on confirmation.

#appointments-and-executive-changes, #califf-robert-m, #drugs-pharmaceuticals, #food-and-drug-administration, #regulation-and-deregulation-of-industry, #senate, #united-states-politics-and-government, #your-feed-healthcare

F.D.A. to Stop Regulating French Dressing

Since 1950, the federal government has defined French dressing and its composition. An industry group said that the standards were outdated and should end.

#association-for-dressings-and-sauces, #consumer-protection, #food-and-drug-administration, #regulation-and-deregulation-of-industry, #salad-dressings, #salads, #supermarkets-and-grocery-stores

U.S. Officials Defend Omicron Response at Senate Hearing

Lawmakers accused top Biden administration health officials of neglecting virus testing and mangling key messaging around the pandemic.

#centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-omicron-variant, #fauci-anthony-s, #food-and-drug-administration, #masks, #tests-medical, #walensky-rochelle, #woodcock-janet

Emerging Data Raise Questions About Antigen Tests and Nasal Swabs

A new study adds to evidence that common rapid tests may fail to detect some Omicron cases in the first days of infection.

#abbott-laboratories, #california, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-omicron-variant, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #new-york-city, #quidel-corporation, #tests-medical, #throat, #your-feed-health, #your-feed-science

More People Are Getting Unapproved Fourth Doses of the Covid-19 Vaccine

People with compromised immune systems are getting unapproved fourth or fifth Covid-19 shots, despite uncertainty about their safety or effectiveness.

#antibodies, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #food-and-drug-administration, #immune-system, #vaccination-and-immunization, #wachter-robert-m

Cannabis to Help You Diet? One Edibles Company Thinks So

An edibles company says one of its products will lead not to the “the munchies” but to weight loss. There’s just one problem: the science.

#advertising-and-marketing, #cannabis-foods-and-products, #clinical-trials, #colorado, #drug-enforcement-administration, #food-and-drug-administration, #marijuana, #medical-marijuana, #national-institutes-of-health, #science-and-technology, #university-of-mississippi

F.D.A. Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters

Regulators will also allow even younger children with immune deficiencies to get an extra shot.

#biontech-se, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #teenagers-and-adolescence, #vaccination-and-immunization, #walensky-rochelle

At-Home Covid Tests Raise Questions About Accurately Counting Cases

Most of the results of rapid tests are not reported. That’s magnifying questions about how best to measure the spread of the virus.

#centers-for-disease-control-and-prevention, #coronavirus-omicron-variant, #food-and-drug-administration, #medicine-and-health, #tests-medical

Here’s How Joe Biden Can Protect Abortion Rights

It’s time to think creatively.

#abortion, #abortion-drugs, #biden-joseph-r-jr, #food-and-drug-administration, #law-and-legislation, #telemedicine, #united-states

Merck’s Covid Pill Cleared by FDA for High-Risk Adults

The F.D.A. said the drug was not a preferred treatment, but could be used when alternate treatment options were “not accessible or clinically appropriate.”

#coronavirus-omicron-variant, #food-and-drug-administration, #merckcompany-inc, #molnupiravir-drug, #united-states

F.D.A. Clears Merck’s Covid Pill for High-Risk Adults

The F.D.A. said the drug could be used when alternate treatment options were “not accessible or clinically appropriate.”

#coronavirus-omicron-variant, #food-and-drug-administration, #merckcompany-inc, #molnupiravir-drug, #united-states

Beneath a Covid Vaccine Debacle, 30 Years of Government Culpability

Washington has rejected plans to revamp vaccine preparedness for decades and repeatedly paid a price. The Biden administration is at a similar crossroads.

#anthrax, #astrazeneca-plc, #biden-joseph-r-jr, #biological-and-chemical-warfare, #biomedical-advanced-research-and-development-authority, #botulism, #coronavirus-2019-ncov, #defense-department, #drugs-pharmaceuticals, #el-hibri-fuad, #emergent-biosolutions-inc, #epidemics, #food-and-drug-administration, #gaithersburg-md, #government-contracts-and-procurement, #johnsonjohnson, #moderna-inc, #politics-and-government, #public-private-sector-cooperation, #smallpox, #stockpiling, #united-states, #vaccination-and-immunization

Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles

A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #drugs-pharmaceuticals, #food-and-drug-administration, #prices-fares-fees-and-rates, #your-feed-healthcare, #your-feed-science

Whiplash on U.S. Vaccine Mandate Leaves Employers ‘Totally Confused’

Companies are struggling to figure out what to do as legal battles and rising Covid cases complicate their plans. Even up in the air: What does “fully vaccinated” mean?

#biden-joseph-r-jr, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-omicron-variant, #coronavirus-return-to-office, #food-and-drug-administration, #labor-and-jobs, #occupational-safety-and-health-administration, #states-us, #suits-and-litigation-civil, #vaccination-and-immunization, #workplace-environment, #workplace-hazards-and-violations

C.D.C. Panel Recommends Other Covid Vaccines Over J.&J.’s Shots

A committee of experts voted on a preference for the Moderna or Pfizer immunizations, citing the risk of blood clots linked to Johnson & Johnson’s product.

#advisory-committee-on-immunization-practices, #astrazeneca-plc, #blood-clots, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #deaths-fatalities, #food-and-drug-administration, #johnsonjohnson, #vaccination-and-immunization

F.D.A. Will Permanently Allow Abortion Pills by Mail

The decision will broaden access to medication abortion, an increasingly common method, but many conservative states are already mobilizing against it.

#abortion, #abortion-drugs, #drugs-pharmaceuticals, #food-and-drug-administration, #mifeprex-ru-486, #telemedicine, #united-states, #women-and-girls, #your-feed-healthcare

A C.D.C. panel weighs the risks of blood clots linked to the J.&J. vaccine.

Public health experts cite concerns about the increased incidence of a rare but potentially serious blood clotting condition among those who received the company’s shot.

#advisory-committee-on-immunization-practices, #blood-clots, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #vaccination-and-immunization

The Future of America’s Abortion Fight

How increased access to one medication could fundamentally change the debate over abortion across the country.

#abortion, #abortion-drugs, #food-and-drug-administration, #reproduction-biological

Senators Question Califf, the F.D.A. Nominee, on Opioid Crisis and Pandemic Response

A Senate panel hearing on Tuesday signaled that Dr. Robert Califf, who briefly led the agency during the Obama administration, had some bipartisan support.

#abortion, #appointments-and-executive-changes, #biden-joseph-r-jr, #califf-robert-m, #consumer-protection, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #google-inc, #labeling-and-labels-product, #opioids-and-opiates, #regulation-and-deregulation-of-industry, #senate-committee-on-health-education-labor-and-pensions, #united-states-politics-and-government, #verily-life-sciences-llc, #your-feed-healthcare

Firms Push for Over-the-Counter Access to Birth-Control Pills

Two drugmakers have been mired for years in the pre-application phase of getting F.D.A. approval for over-the-counter use.

#birth-control-and-family-planning, #cadence-health-inc, #drugs-pharmaceuticals, #food-and-drug-administration, #hra-pharma, #medicine-and-health

Merck’s Covid Treatment Pill Wins Blessing of F.D.A. Panel

The treatment, known as molnupiravir, could be authorized in the United States within days, and available within weeks, if the F.D.A. follows the committee’s recommendation.

#antibodies, #clinical-trials, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-omicron-variant, #drugs-pharmaceuticals, #food-and-drug-administration, #merckcompany-inc, #molnupiravir-drug

F.D.A. Advisers Meets on Merck’s Covid Pill

If an expert committee votes to recommend it, the drug, molnupiravir, could be authorized within days for patients at high risk of severe illness.

#coronavirus-2019-ncov, #coronavirus-omicron-variant, #food-and-drug-administration, #merckcompany-inc, #molnupiravir-drug, #vaccination-and-immunization

Counterfeit Covid Masks Are Still Sold Everywhere

Rising Covid cases have spurred a return to mask-wearing in the U.S. and overseas, at a time when flawed KN95s from China continue to dominate e-commerce sites.

#amazon-com-inc, #centers-for-disease-control-and-prevention, #consumer-reviews, #coronavirus-2019-ncov, #counterfeit-merchandise, #e-commerce, #food-and-drug-administration, #international-trade-and-world-market, #masks, #protective-clothing-and-gear, #united-states-politics-and-government, #warren-elizabeth

Vaping Is Risky. Why Is the F.D.A. Authorizing E-Cigarettes?

The agency has taken a controversial stand on vaping as a way to quit tobacco. This is what the research shows.

#centers-for-disease-control-and-prevention, #e-cigarettes, #food-and-drug-administration, #nicotine, #research, #smoking-and-tobacco

Concerns Grow Over Safety of Aduhelm After Death of Patient Who Got the Drug

Newly published safety data shows that 41 percent of patients in key clinical trials of the Alzheimer’s drug experienced brain bleeding or swelling, though many cases were asymptomatic.

#aduhelm-drug, #alzheimers-disease, #biogen-inc, #brain, #clinical-trials, #deaths-fatalities, #drugs-pharmaceuticals, #elderly, #food-and-drug-administration, #jama-neurology-journal, #labeling-and-labels-product, #rbc-capital-markets, #research, #your-feed-science

C.D.C. Endorses Covid Vaccine Booster Shots for All Adults

As infections rise, Americans over 18 will be permitted to get extra doses. But it’s not clear boosters really are needed by so many people, or that the shots will turn back the pandemic.

#biontech-se, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #coronavirus-delta-variant, #coronavirus-risks-and-safety-concerns, #disease-rates, #food-and-drug-administration, #pfizer-inc, #united-states, #vaccination-and-immunization, #your-feed-science

F.D.A. Authorizes Coronavirus Booster Shots for All Adults

If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by this weekend.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #moderna-inc, #pfizer-inc, #united-states-politics-and-government, #vaccination-and-immunization

Our Covid Failures Don’t Have to Define Our Future

We need to learn the right lessons from the pandemic.

#centers-for-disease-control-and-prevention, #content-type-service, #coronavirus-2019-ncov, #disease-rates, #epidemics, #food-and-drug-administration, #tests-medical, #united-states, #united-states-politics-and-government, #vaccination-and-immunization

F.D.A. Plans to Authorize Pfizer Boosters for All Adults This Week

Regulators are set to clear extra doses of Pfizer-BioNTech’s vaccine as soon as Thursday, after states began expanding eligibility on their own.

#biontech-se, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #regulation-and-deregulation-of-industry, #united-states-politics-and-government, #vaccination-and-immunization

U.S. to Buy Enough of Pfizer’s Covid Antiviral Pills for 10 Million People

The antiviral drugs have helped inspire hope among senior administration officials that the United States will be able to curb the devastating toll from the Delta variant.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #merckcompany-inc, #pfizer-inc, #stockpiling, #united-states-politics-and-government

Pfizer Asks F.D.A. to Authorize Covid Pill For Unvaccinated People

The treatment, Paxlovid, is the second antiviral pill to show effectiveness in treating Covid, and works differently from the first.

#coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #regulation-and-deregulation-of-industry, #united-states

Biden to Choose Robert Califf to Lead F.D.A., Despite Drug Industry Ties

Dr. Robert M. Califf, an academic and clinical trial researcher who ran the agency in 2016, has also consulted for pharmaceutical companies.

#appointments-and-executive-changes, #biden-joseph-r-jr, #califf-robert-m, #clinical-trials, #conflicts-of-interest, #drugs-pharmaceuticals, #duke-university, #food-and-drug-administration, #manchin-joe-iii, #regulation-and-deregulation-of-industry, #united-states-politics-and-government

Veterans Have Become Unlikely Lobbyists in Push to Legalize Psychedelic Drugs

Lawmakers find it hard to “just say no” to combat veterans seeking support for drug decriminalization efforts gaining traction around the country.

#afghanistan-war-2001, #anxiety-and-stress, #audio-neutral-informative, #food-and-drug-administration, #mental-health-and-disorders, #post-traumatic-stress-disorder, #psilocybin-mushrooms, #psychedelic-and-hallucinogenic-drugs, #veterans, #your-feed-healthcare

Pfizer Asks F.D.A. to Expand Booster Eligibility to All Adults

In a turnaround, the agency is expected to grant the request before the winter holiday season, giving access to all 181 million fully vaccinated people.

#biontech-se, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #regulation-and-deregulation-of-industry, #united-states-politics-and-government, #vaccination-and-immunization

Congress Is Investigating McKinsey Over Its Role in the Opioid Crisis

A House committee has requested documents related to the firm’s advice to drug makers and potential conflicts of interest with the F.D.A.

#food-and-drug-administration, #house-committee-on-oversight-and-government-reform, #maloney-carolyn-b, #mckinseyco, #opioids-and-opiates, #oxycontin-drug, #united-states-politics-and-government

Federal Government Cuts Ties With Troubled Vaccine Maker

Emergent BioSolutions ruined millions of doses of Covid-19 vaccines. Now its $600 million deal is canceled.

#anthrax, #astrazeneca-plc, #coronavirus-2019-ncov, #emergent-biosolutions-inc, #food-and-drug-administration, #government-contracts-and-procurement, #health-and-human-services-department, #johnsonjohnson, #kramer-robert-g, #vaccination-and-immunization

Covid-19 and Children: How Often Do Vaccines Cause Heart Problems?

The latest data is reassuring. Myocarditis remains very uncommon, and it is almost always mild and temporary. The heart risk from Covid-19 itself is far greater.

#biontech-se, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #food-and-drug-administration, #heart, #moderna-inc, #pfizer-inc, #teenagers-and-adolescence, #united-states, #vaccination-and-immunization, #your-feed-science

Covid Shots Are a Go for Children, but Parents Are Reluctant to Consent

Vaccinating 5- to 11-year-olds could be a big step toward returning to normal life in the U.S., but even parents who got the shot are worried about how it might affect their kids.

#children-and-childhood, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #food-and-drug-administration, #parenting, #polls-and-public-opinion, #vaccination-and-immunization, #your-feed-science

Suffering From Confounding Symptoms, a Patient Treats Himself

In “The Deep Places,” Ross Douthat chronicles the illness that continued to plague him no matter what he threw at it.

#antibiotics, #books-and-literature, #connecticut, #douthat-ross-g, #food-and-drug-administration, #lyme-conn, #lyme-disease, #new-york-times, #therapy-and-rehabilitation

F.D.A. Expected to Clear Pfizer Coronavirus Vaccine for Young Children

Experts said the shot could bring relief to parents anxious about their children getting sick, though some worry that those most at risk may slip through the cracks.

#american-academy-of-family-physicians, #american-academy-of-pediatrics, #centers-for-disease-control-and-prevention, #children-and-childhood, #coronavirus-2019-ncov, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

Patients Must Be Warned of Breast Implant Risks, F.D.A. Says

A decade after scientists identified a link between certain implants and cancer, the agency ordered “black box” warnings and a new checklist of risks for patients to review.

#breast-cancer, #breasts, #food-and-drug-administration, #implants, #lymphoma, #medical-devices, #plastic-surgery, #surgery-and-surgeons, #united-states, #women-and-girls, #your-feed-science

F.D.A. Panel Recommends Vaccine for Children 5 to 11

Covid-19 was “the eighth-highest killer of kids in this age group over the past year,” said a C.D.C. official in favor of broader authorization.

#centers-for-disease-control-and-prevention, #children-and-childhood, #coronavirus-2019-ncov, #coronavirus-risks-and-safety-concerns, #disease-rates, #food-and-drug-administration, #pfizer-inc, #united-states-politics-and-government, #vaccination-and-immunization

Are Vaccine Boosters Widely Needed? Some Federal Advisers Have Misgivings.

“In our hearts, I think people don’t quite agree with this notion of a booster dose,” said one leading vaccine expert.

#advisory-committee-on-immunization-practices, #biontech-se, #centers-for-disease-control-and-prevention, #coronavirus-2019-ncov, #food-and-drug-administration, #johnsonjohnson, #moderna-inc, #pfizer-inc, #vaccination-and-immunization, #your-feed-science

F.D.A. Says Pfizer Vaccine’s Benefits Outweigh Key Risks in Children 5 to 11

The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps as early as next week, a long-awaited development that would affect 28 million children.

#biontech-se, #centers-for-disease-control-and-prevention, #children-and-childhood, #clinical-trials, #coronavirus-2019-ncov, #drugs-pharmaceuticals, #food-and-drug-administration, #pfizer-inc, #vaccination-and-immunization

Salmonella Outbreak Linked to Onions Sickens More Than 650

The C.D.C. urged consumers to throw away any whole red, white or yellow onions they purchased that do not have a sticker or packaging.

#bacteria, #centers-for-disease-control-and-prevention, #chihuahua-mexico, #food-and-drug-administration, #food-contamination-and-poisoning, #idaho, #infections, #onions, #recalls-and-bans-of-products, #salmonella-bacteria