Top Stories

  • A clinical trial testing whether adding Eli Lilly & Co.’s antibody drug to Gilead Sciences Inc.’s remdesivir would help hospitalized COVID-19 patients was temporarily paused for a potential safety concern at the recommendation of an independent data safety monitoring board, Lilly confirmed. The safety board said it would review data from the trial, which had enrolled 326 patients since August, and make a recommendation about whether enrollment should resume at its Oct. 26 meeting. (The Wall Street Journal)
  • Two senior White House officials pushed a declaration arguing for a “herd immunity” approach to the coronavirus pandemic that rejects “lockdown policies” and allows “those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection.” Many health experts disagree with the declaration’s positions and say herd immunity is still far-off in the United States, and research indicates about 85 to 90 percent of Americans are still vulnerable to the virus. (The New York Times)
  • Health insurers had an extremely healthy second quarter, with UnitedHealth Group Inc. recording its highest-ever profit, while pharmaceutical companies and hospitals brought in the highest net profit margins among health care groups included in a news outlet’s earnings tracker. The coronavirus pandemic prompted people to delay care this spring and summer, but medical device sales are now “recovering faster than expected,” according to Johnson & Johnson executives, and hospital executives expect a “sharp recovery” over the next year, a survey found. (Axios)
  • In the second day of confirmation hearings for Supreme Court nominee Amy Coney Barrett, the judge said her personal views on health care and abortion would not affect her decisions on the high court, though she deflected questions about how she would rule in such cases and said she didn’t view Roe v. Wade, the 1973 decision that legalized abortion, as a “super precedent” that cannot be overturned. Under questioning from Democrats, who have made health care access central to her confirmation battle, Barrett said she was not “on a mission to destroy the Affordable Care Act,” though she has criticized a previous Supreme Court decision to uphold the 2010 health care law. (The Washington Post)

Chart Review

Events Calendar (All Times Local)

10/14/2020
HLTH 2020
BIO Investor Forum
Better Medicare Alliance Medicare Advantage Summit 2020
American Health Information Management Association 2020 Conference
Everbridge Coronavirus Symposium: The Road To Recovery Featuring President George W. Bush 1:40 pm
10/15/2020
HLTH 2020
BIO Investor Forum
Better Medicare Alliance Medicare Advantage Summit 2020
American Health Information Management Association 2020 Conference
Everbridge Coronavirus Symposium: The Road To Recovery Featuring Dr. Anthony Fauci 12:10 pm
10/16/2020
HLTH 2020
Better Medicare Alliance: Medicare Advantage Summit 2020
American Health Information Management Association 2020 Conference
10/17/2020
American Health Information Management Association 2020 Conference
National Academy of Medicine Annual Meeting
10/18/2020
National Academy of Medicine Annual Meeting
10/19/2020
Milken Institute Global Conference: Social Isolation: Confronting the Silent Pandemic 2:30 pm
National Academy of Medicine Annual Meeting
View full calendar


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Coronavirus

FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization
Adam Cancryn, Politico

The FDA is resisting Trump administration pressure to rebrand the emergency authorization of a Covid-19 vaccine as a “pre-licensure,” over worries that it would appear the agency is politicizing its scientific determinations, according to four senior administration officials with knowledge of the debate.

Trump again attacks Fauci’s guidance as coronavirus infections tick upward
David Nakamura, The Washington Post

President Trump’s long-fraught relationship with Anthony S. Fauci, the nation’s top infectious-disease specialist, ruptured again this week in an ugly public dispute just as U.S. coronavirus cases have ticked past 50,000 per day and with three weeks left in a campaign dominated by the government’s response to the pandemic.

Fauci: Trump’s rapid recovery from Covid-19, while welcome, ‘amplifies’ public misunderstanding of disease
Helen Branswell, Stat News

Health officials have struggled to convey the seriousness of Covid-19 to many Americans.

Coronavirus Reinfections Are Real but Very, Very Rare
Apoorva Mandavilli, The New York Times

Reports of reinfection with the coronavirus evoke a nightmarish future: Repeat bouts of illness, impotent vaccines, unrelenting lockdowns — a pandemic without an end.

Lilly CEO Says Covid Will Be ‘Endemic,’ Even With Vaccines: Q&A
Erik Schatzker, Bloomberg

Was it a blessing or a curse for Eli Lilly & Co. that President Donald Trump was treated with coronavirus antibodies made by rival Regeneron Pharmaceuticals Inc.? Neither, according to David Ricks, Lilly’s chief executive officer.

J&J Vaccine Pause Shows Challenges Still Ahead for Covid-19 Shots
Jenny Strasburg and Drew Hinshaw, The Wall Street Journal

The pause of Johnson & Johnson’s Covid-19 vaccine trials poses another setback for global efforts to develop a shot to protect lives and jump-start economies battered by the pandemic, as well as a reminder of the challenges of fast-tracking vaccine development.

Medicare Preparing Rule to Ensure Swift Access to Covid Vaccine
Tony Pugh, Bloomberg Law

The Centers for Medicare & Medicaid Services has a plan to ensure full payment for and speedy access to new Covid-19 vaccines and treatments for Medicare beneficiaries, agency Administrator Seema Verma said Tuesday at a virtual conference.

Deep freezers and dry ice for Pfizer vaccine may face shortages
Emily Kopp, Roll Call

States are getting little federal assistance as they scramble to find medical-grade deep freezers or dry ice for one of the COVID-19 vaccines furthest along in development, which requires storage at much colder temperatures than found on an average winter day on the South Pole.

Cytiva to Manufacture Covid Vaccine Supplies Under HHS Contract
Cheryl Bolen, Bloomberg Law

Massachusetts-based Cytiva will expand its manufacturing capacity for products essential to producing Covid-19 vaccines under an agreement announced Tuesday by the Department of Health and Human Services.

Gilead’s remdesivir shaved five days off COVID-19 recovery time, reduced risk of death in some
Julie Steenhuysen, Reuters

Final data from Gilead Sciences Inc’s antiviral drug remdesivir showed the treatment cut COVID-19 recovery time by five days compared with patients who got a placebo, one day faster than indicated in preliminary data, the company and researchers said on Thursday.

Ezekiel Emanuel on vaccines, Trump’s Covid-19 treatment, and what went wrong on the U.S. response
Ed Silverman, Stat News

The controversy surrounding the Trump administration response to the Covid-19 pandemic grew still thornier after President Trump contracted the virus himself 11 days ago.

Coronavirus Vaccine Makers Are Not Mass-Slaughtering Sharks
Katherine J. Wu, The New York Times

Several companies in the race for a coronavirus vaccine have stumbled upon a new and unexpected hurdle: activists protesting the use of a substance that comes from sharks in their products.

Payers

Trump’s Drug-Discount Cards Expected to Reach Medicare Recipients After Election
Stephanie Armour, The Wall Street Journal

President Trump’s plan to send 33 million Medicare beneficiaries a card that can be used to help pay for as much as $200 in prescription drug costs won’t be completed until after the election, according to a person familiar with the plan.

A $52,112 Air Ambulance Ride: Coronavirus Patients Battle Surprise Bills
Sarah Kliff, The New York Times

Bills submitted to The New York Times show that patients often face surprise charges from out-of-network doctors, ambulances and medical laboratories they did not pick or even realize were involved in their care.

Providers

Kaiser CEO promises strategic shift to stronger focus on equity: HLTH 2020
Rebecca Pifer, Healthcare Dive

The Oakland, California-based nonprofit plans to bring ethnicity and race factors into how it evaluates quality and care across the organization, Adams said Monday at the HLTH virtual conference.

Pharma, Biotech and Devices

FDA faults quality control at Lilly plant making Trump-touted COVID drug
Dan Levine, Marisa Taylor, Reuters

Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.

J&J to contribute up to $5 billion to potential U.S. opioid settlement
Nate Raymond, Reuters

Johnson & Johnson said on Tuesday it will contribute up to $1 billion more to a potential settlement of lawsuits alleging it and other companies fueled the U.S. opioid epidemic, bringing its total payment to $5 billion.

Elizabeth Holmes Loses Request to Throw Out Criminal Charges
Peter Blumberg, Bloomberg

Elizabeth Holmes lost her latest long-shot challenge to U.S. criminal charges that she was engaged in a massive fraud while running Theranos Inc.

Johnson & Johnson beats third-quarter earnings expectations, raises guidance
Berkeley Lovelace Jr., CNBC

Johnson & Johnson on Tuesday reported third-quarter earnings and revenue that beat Wall Street’s expectations, led by higher sales in its medical-device unit and higher demand for some of its drugs.

Health Technology

Teladoc Sues Rival Over Hospital Robot Patents
Sarah Krouse, The Wall Street Journal

Teladoc Health Inc., the country’s largest publicly traded telemedicine provider, has sued rival American Well Corp. for alleged patent violations related to technology behind robot-like carts that connect hospitalized patients with specialists in real time via video.

Facebook Bans Ads Discouraging Vaccines, In Latest Misinformation Crackdown
Shannon Bond, NPR News

Facebook said on Tuesday it will ban anti-vaccination ads, following widespread pressure on the social network to curb harmful content.

Results are coming in on the AI systems built at the height of New York City’s spring Covid-19 outbreak
Rebecca Robbins, Stat News

At the peak of the Covid-19 wave that swept through New York City in the spring, with hospitals overwhelmed and more than 700 new virus deaths being reported each day, researchers there scrambled to build artificial intelligence models that could help doctors get a handle on the crisis.

Opinions, Editorials and Perspectives

New California law should serve as a national model for mental health care reform
Darrell Steinberg and Patrick J. Kennedy, Stat News

As our nation continues to confront the ramifications of a global pandemic, the stigma around mental health and addiction seems to be dissipating.

Research Reports

Family and Friend Perceptions of Quality of End-of-Life Care in Medicare Advantage vs Traditional Medicare
Claire K. Ankuda et al., JAMA Network Open

In this cross-sectional study of people who died while enrolled in Medicare, friends and family of those in Medicare Advantage reported lower-quality end-of-life care compared with friends and family of those enrolled in traditional Medicare. These findings suggest that, given the rapid growth of MA, Medicare should take steps to ensure that MA plans are held accountable for quality of care at the end of life.

General

Women voters say health care is on the line this year — and they aren’t hearing enough about it
Shefali Luthra, The 19th

Women “health care voters” fueled Democrats’ midterm election gains in 2018. Those voters want to hear more about how presidential candidates would change a system they say still isn’t working.

Morning Consult