Coronavirus
How the F.D.A. Stood Up to the President
Sheila Kaplan et al., The New York Times
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.
U.S. trial of AstraZeneca COVID-19 vaccine may resume this week – sources
Julie Steenhuysen and Marisa Taylor, Reuters
AstraZeneca Plc’s COVID-19 vaccine trial in the United States is expected to resume as early as this week after the U.S. Food and Drug Administration completed its review of a serious illness in a study participant, four sources told Reuters.
States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA
Zachary Brennan, Politico
Several states are setting up their own coronavirus vaccine reviews to counter public safety concerns as the Trump administration pushes the Food and Drug Administration to approve a shot on an aggressive timeline that they fear could be too rushed.
Antibody Treatments, Though Promising, Will Be in Short Supply
Katie Thomas, The New York Times
Even if the drugs are proven to work — still a big if — there’s little chance that they will soon be widely available.
Lilly Plant Making Covid Drug Is Flagged Again by FDA Inspectors
Anna Edney, Bloomberg
U.S. drug-safety inspectors have found continuing quality-control problems problems at a New Jersey plant Eli Lilly & Co. is using to help produce its Covid-19 antibody therapy, posing a potential obstacle to the company meeting its goal of producing 1 million doses by year-end.
Pfizer Sets Up Its ‘Biggest Ever’ Vaccination Distribution Campaign
Costas Paris and Jared S. Hopkins, The Wall Street Journal
Like other drugmakers testing potential vaccines, Pfizer is urgently laying the groundwork with its logistics partners so it can move quickly if its vaccine gets the go-ahead from the Food and Drug Administration and other regulators around the world.
Public health experts push vaccine makers, HHS to release Covid-19 trial protocols
Ed Silverman, Stat News
Amid concerns over a lack of transparency Covid-19 product development, more than two dozen academics and health policy experts are urging federal officials and several vaccine makers to fully disclose all information concerning their clinical trial protocols and agreements.
Disjointed Covid-19 Apps Across U.S. Raise Questions About Tech’s Role
David Uberti, The Wall Street Journal
Months after a burst of optimism about the potential for technology to help track the spread of Covid-19, a hodgepodge of mobile phone apps around the U.S. has yielded unclear results amid inconsistent policies and usage.
White House flags 31 ‘red zone’ states for new cases per capita
Meryl Kornfield, The Washington Post
Most of the country is battling a concerning number of new coronavirus infections per capita, according to a weekly White House coronavirus task force report shared with state health officials on Sunday.
Payers
Republicans Say Obamacare Is Thriving Under Trump Administration
Alex Ruoff, Bloomberg Law
Republicans are trying to sell the Trump administration as the best steward of Obamacare, despite the increasing number of uninsured people and the push to upend the health law.
N.Y. Accuses Christian Group of Misleading Consumers on Health Coverage
Reed Abelson, The New York Times
New York State accused a major Christian group on Tuesday of deceiving customers by illegally offering health insurance to as many as 40,000 residents since 2016.
Nebraska Gets OK to Set Work, Wellness Rules for Health Benefits
Christopher Brown, Bloomberg Law
Nebraska won federal approval of its plan to require some Medicaid enrollees to complete work and wellness requirements to get dental insurance and other health benefits.
Lawmakers press HHS for documents on Trump’s drug-card plan
Dan Diamond, Politico
Senior Democratic lawmakers are demanding that the health department turn over internal documents on President Donald Trump’s plan to give seniors $200 discount cards to buy prescription drugs, following a POLITICO report that the department’s top lawyer warned the plan could violate election law.
Providers
Providers’ rocky road to recovery could last into 2022
Shannon Muchmore, Healthcare Dive
As health systems are set to start reporting their third quarter earnings results this week, new research highlights hospitals’ ongoing fears about financial viability, patient volumes and supply stocks.
The overwhelming aftershocks of the pandemic
Caitlin Owens, Axios
The pre-pandemic health care system was already full of holes, many of which have been exposed and exacerbated over the past several months, and many Americans will be stuck with that system as they grapple with the long-term consequences of the pandemic.
Pharma, Biotech and Devices
Justice Department Presses to Curtail Purdue Pharma Bankruptcy Probe
Peg Brickley and Sara Randazzo, The Wall Street Journal
The Justice Department is urging a bankruptcy judge to limit a creditor probe of OxyContin maker Purdue Pharma LP into the billions of dollars in profits collected by the Sackler family members who own the company.
Novartis to pursue SMA drug branaplam in Huntington’s disease
John Miller, Reuters
Novartis is seeking to repurpose its investigational oral spinal muscular atrophy (SMA) drug branaplam to treat Huntington’s disease, the Swiss drugmaker said on Wednesday, as it plans a clinical trial after winning U.S. orphan drug designation.
Health Technology
Lyra mental health service teams up with Calm meditation app
Christina Farr, CNBC
Lyra Health, a richly funded start-up selling employee mental health services to businesses, is adding meditation, mindfulness and sleep support to its program through a new partnership with app-maker Calm.
What do patients think about AI in the clinic? The FDA wants to find out
Casey Ross, Stat News
Autonomous AI systems are rapidly making their way into the health care system, presenting regulators with thorny questions about how to protect data, prevent bias, and make sure constantly evolving machines can operate safely in clinical practice.
Bridging the Miles — And the Pandemic — Teledentistry Makes Some Dentists Wince
Eric Berger, Kaiser Health News
Teledentistry allows dental professionals like Planerova to remotely review records and diagnose patients over video.
Opinions, Editorials and Perspectives
Children and families need resources to address trauma at its roots
Ayanna Pressley and Carolyn B. Maloney, Stat News
As we move through this moment of collective trauma, we must adopt focused, evidence-based approaches to make our country whole again and ensure that these approaches prioritize a precious responsibility — our children’s future.
Research Reports
Risk for In-Hospital Complications Associated with COVID-19 and Influenza — Veterans Health Administration, United States, October 1, 2018–May 31, 2020
Centers for Disease Control and Prevention
Compared with influenza, COVID-19 is associated with increased risk for most respiratory and nonrespiratory complications, the study found.
General
As election nears, Trump leans on health care agencies to aid his campaign
Lev Facher, Stat News
Amid mounting desperation about his reelection odds, President Trump has increasingly come to rely on an unorthodox campaign tool: the Department of Health and Human Services.
Senators urge Pentagon to suspend implementation of Army’s new fitness test
Missy Ryan, The Washington Post
Democratic senators appealed Tuesday for support of a legislative proposal that would suspend implementation of the Army’s new fitness test, arguing that the high-profile initiative to improve physical readiness is based on faulty data and could undermine the goal of creating a diverse force.
Cancer research another long-term casualty of the coronavirus pandemic, scientists say
Linda Givetash, NBC News
The pandemic has caused unprecedented disruptions in medical research for potentially lifesaving cancer treatments.
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