The Health and Human Services Department’s Office of Inspector General said in a report that the Food and Drug Administration’s emergency use authorization policies resulted in quality issues and false results with COVID-19 tests that quickly hit the market during the early stages of the pandemic. The HHS watchdog said the government should overhaul its EUA strategy before another pandemic occurs, advocating for a “coordinated federal effort to determine a federal testing strategy” that involves stakeholder feedback, improved communication practices with testing labs, more specific guidance on test validation and additional FDA support throughout the process. (Modern Healthcare)
The reformulated COVID-19 boosters from Moderna Inc. and Pfizer Inc.-BioNTech SE are expected to be available for children by the middle of next month, per the Centers for Disease Control and Prevention, with a recommendation from the agency coming as soon as early October provided the shots are authorized by the FDA. The Pfizer bivalent vaccine would be available for children ages 5-11, while Moderna’s booster is expected to be used in kids between 6 and 17, the CDC said. (Reuters)
Dr. Anthony Fauci said during an interview at The Atlantic Festival that President Joe Biden’s declaration that “the pandemic is over” was “semantics” and that he actually intended to convey that “we’re in a much better place with regard to the fulminant stage of the pandemic.” Fauci said the country is in a new phase where vaccines and antiviral treatments ensure that there aren’t sudden surges in the death toll, even as case counts and hospitalization rates seesaw. (The Atlantic)
HHS Secretary Xavier Becerra declared a public health emergency in Puerto Rico after the island was battered by Hurricane Fiona last weekend and continues to deal with flooding, power outages and other fallout from the storm. HHS’ National Disaster Medical System has sent 15 people to Puerto Rico, while another 10 from the agency’s management team are also on the island, moves that come after Biden issued an emergency declaration and charged the Federal Emergency Management Agency and the Department of Homeland Security with overseeing disaster relief. (The Hill)
Worth watching today (all times local):
8:30 a.m.FDA meeting of the Vaccines and Related Biological Products Advisory Committee.
9 a.m.FDA meeting of the Oncologic Drugs Advisory Committee.
10 a.m. AEI event: “Access to Obesity Care in the US: Coverage in a New Era of Treatments.”
11:30 a.m. Washington Post Live event: “The real cost of unpaid caregiving and impact of the pandemic.”
12:30 p.m. Axios event: “The Nation’s Mental Health Crisis,” featuring Substance Abuse and Mental Health Services Administration Administrator Miriam E. Delphin-Rittmon.
The latest phase of the Covid pandemic is shaping up to be the hardest for the Biden administration as the White House faces uphill battles getting new funds and public interest for its booster campaign.
As California settles into a third year of pandemic, covid-19 continues to pose a serious threat of death. But the number of people dying — and the demographics of those falling victim — has shifted notably from the first two years.
The discussion draft (PDF), released Thursday by the Senate Finance Committee, is part of a larger effort by the panel to reform mental health. The legislation would also boost bonus payments for mental health providers that offer care to underserved communities.
The World Health Organization warned in a report Wednesday that most countries are “far off track” in their efforts to reduce premature deaths from noncommunicable diseases (NCDs), such as cancer, diabetes and cardiovascular diseases.
Experts say the spike in overdoses and diseases related to sharing needles means it’s time to revoke a longtime ban restricting federal funds for syringe exchanges. But lawmakers in both parties remain resistant to allowing taxpayer dollars to go toward clean needles and syringes for drug use.
“We use the mosquitoes like they’re 1,000 small flying syringes,” explains University of Washington, Seattle physician and scientist Dr. Sean Murphy, lead author on a paper in Science Translational Medicine released on August 24 detailing the vaccine trials.
A cashier with psoriasis received daily complaints from customers at work. A traveler with eczema was escorted off a flight and questioned by airline employees. A commuter with small, benign tumors on her body was unknowingly filmed and scrutinized on social media. All of them were singled out because people mistakenly believed they had monkeypox.
Private equity firms are investing in health care from cradle to grave, and in that latter category quite literally. A small but growing percentage of the funeral home industry — and the broader death care market — is being gobbled up by private equity-backed firms attracted by high profit margins, predictable income, and the eventual deaths of tens of millions of baby boomers.
Women of color are at higher risk of maternal health complications, and those disparities persist regardless of whether they are enrolled in commercial health plans or Medicaid coverage, a new study found.
The report by the House of Representatives’ Select Subcommittee on the Coronavirus Crisis examined five for-profit chains operating about 850 homes with 80,000 residents during the early months of the pandemic, drawing on complaints filed against the companies. About 70% of nursing homes in the US are run by for-profit operators.
Doctors at online and brick and mortar primary care companies are slowly starting to prescribe medication abortion pills via telemedicine in states where it’s still legal following the Supreme Court’s Dobbs decision ending the constitutional right to the procedure.
The US Department of Health and Human Services has released the 2022 National Strategy to Support Family Caregivers through the Administration for Community Living, according to a Wednesday news release.
The U.S. Food and Drug Administration on Tuesday warned that certain types of insulin pump systems manufactured by Medtronic (MDT.N) were vulnerable to cyberattacks and that hackers could potentially hamper insulin delivery by accessing the device.
Novartis AG (NOVN.S) plans to ask the U.S. Supreme court to uphold the validity of a patent it holds on the dosing regimen for multiple sclerosis drug Gilenya after suffering a setback in a federal appeals court ruling, the Swiss drugmaker said on Wednesday.
Longer-term use and early initiation of Biogen Inc’s (BIIB.O) experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS) was effective in slowing disease progression, according to a new analysis by the company published on Wednesday.
Lauren Berryman and Kara Hartnett, Modern Healthcare
As Hurricane Fiona reached Puerto Rico late Sunday night, flooding the archipelago and tipping its battered energy grid into a blackout, healthcare industry leaders and government agencies were bracing for impact.
Partisan bickering is holding up a biomedical innovation bill in the House, the legislation’s main Democratic sponsor said.
A Message From the Partnership for Quality Home Healthcare:
Older Americans and Medicare beneficiaries overwhelmingly prefer home healthcare, but proposed Medicare cuts will threaten their access to care. The proposed cuts will also cause overall costs of care to go up due to increased hospital readmission rates, unnecessary hospitalizations, and increased use of nursing home stays. Congress must act quickly to prevent these disastrous cuts from going into effect by passing the Preserving Access to Home Health Act. Learn more at PQHH.org/cuts.
The past decade has witnessed a rapid expansion of genetic tests, including new instruments to inform patients who have been diagnosed with breast cancer about the risk of recurrence and to guide their treatment.
The short history of CRISPR gene editing in humans has, with rare exception, been a history of triumphant progress: A patient apparently cured of sickle cell in 2019, six patients with toxic DNA knocked out of their livers last year, another six patients with a different strand of toxic liver DNA knocked out last week.
Researchers reported Wednesday that they could quickly and reliably turn CAR-T cells on and off in cancer patients, giving scientists an unprecedented level of control over this potent — but at times dangerous — oncology therapy.
The Centers for Disease Control and Prevention recommends that everyone over 12 receive a “bivalent” Covid-19 vaccine as a booster dose. But only a select group are likely to benefit, and the evidence to date doesn’t support the view that a bivalent vaccine containing omicron or its subvariants is better than the monovalent vaccine. The CDC risks eroding the public’s trust by overselling the new shot.
The coronavirus disease 2019 (COVID-19) pandemic increased risk of incident and worsening HRSVs for caregivers more than for non-caregivers. COVID-19 response and recovery efforts should target caregivers to reduce modifiable HRSVs and promote the health of caregivers and those who depend on them.