Morning Consult Health: Becerra Declares Monkeypox a Public Health Emergency
 

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August 5, 2022
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  • The monkeypox outbreak was declared a public health emergency by the Biden administration, as Health and Human Services Secretary Xavier Becerra called on all Americans to “take responsibility to help us tackle this virus” and left the door open for a second declaration that would accelerate possible treatments and vaccines without being subjected to the standard, full-fledged federal reviews. Food and Drug Administration Commissioner Robert Califf said officials are mulling a “dose-sparing” plan to squeeze five doses per vial out of the Danish-produced Jynneos monkeypox vaccine. (The Washington Post)
  • Senate Majority Leader Chuck Schumer (D-N.Y.) is teeing up a Saturday afternoon vote on a motion to proceed with the party’s reconciliation bill after Sen. Kyrsten Sinema (D-Ariz.) said she’d back the bill following an agreement with colleagues to eliminate the carried-interest provision for fund managers and add a 1% excise tax on stock buybacks, clearing Democrats’ last intraparty hurdle. The Senate parliamentarian today will review the package’s updated language on measures to lower prescription drug prices, a Democratic aide said, while an additional provision from Sen. Raphael Warnock (D-Ga.) to lower the cost of insulin is expected to face GOP challenges. (Politico)
  • PhRMA and its 31 board members sent a letter to every member of Congress yesterday imploring them to vote against Democrats’ reconciliation package, while Steve Ubl, head of the powerful trade group representing drugmakers, said in an interview that lawmakers “who vote for this bill will not get a free pass.” The letter mostly sticks to arguments PhRMA has made in a multimillion-dollar advocacy campaign railing against the drug pricing provisions in the bill, saying that the measures would “put the U.S. system on a course toward broad government control, setting the stage for our country to fall behind.” (Politico)
  • Amgen Inc. struck a $3.7 billion deal to buy ChemoCentryx Inc., giving the biotech access to Tavneos, a drug used to treat patients with a rare type of blood vessel inflammation that generated $5.4 million in sales in the first full quarter after its regulatory approval. Amgen reported second-quarter revenue of $6.59 billion, a 1% jump from the year-ago period fueled by a 13% rise in sales of its osteoporosis drug Prolia. (Reuters)
 

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What Else You Need to Know

Coronavirus
 

1 in 8 Covid Patients Experience Lingering Symptoms, Study Shows

Jason Gale, Bloomberg

One in eight people recovering from Covid-19 had lingering symptoms due to the illness at least three months later in a study that provides greater clarity on the ailments triggered by the pandemic disease.

 

Over 1 million courses of Paxlovid prescribed in one month for first time

Oriana Gonzalez, Axios

July marked the first month that more than 1 million courses of Pfizer’s COVID antiviral Paxlovid were prescribed, according to Biden administration figures provided to Axios.

 

The Coronavirus Has One Strategy We Can’t Vaccinate Against

Katherine J. Wu, The Atlantic

By the time a cell senses that it’s been infected by a virus, it generally knows it is doomed. Soon, it will be busted up by the body’s immunological patrol or detonated by the invader itself. So the moribund cell plays its trump card: It bleats out microscopic shrieks that danger is nigh.

 

Fauci has a stark warning for you: Get those COVID vaccines and boosters now, or you’re ‘going to get into trouble’

Chloe Taylor, Fortune

Anyone who hasn’t had all their COVID vaccination shots could be in for a difficult time as the colder seasons approach and the virus continues to spread, America’s top doctor has warned.

 

Blood clots, heart problems, kidney failure: COVID creates a higher risk for rare pediatric health problems, new CDC study finds

Erin Prater, Fortune

Children and teens who’ve had COVID are at greater risk for blood clots, heart problems, kidney failure, and type 1 diabetes, according to a new report released Thursday by U.S. health officials.

 

Biden still COVID positive but “feels very well,” doctor says

Oriana Gonzalez and Ivana Saric, Axios

President Biden tested positive for COVID-19 again Thursday and is still experiencing “a very occasional cough” which is “improving,” his physician said in a letter.

 
General
 

Clinton-era FDA commissioner to lead external review of key agency offices

Katherine Ellen Foley and Adam Cancryn, Politico

Jane Henney, a former commissioner of the FDA, has been tapped by the Reagan-Udall Foundation to lead a FDA-requested external review of key agency offices on human food safety and tobacco regulation, two sources with knowledge of the matter told POLITICO.

 

What Should Worry Most Americans About Our Monkeypox Response

Katherine J. Wu, The Atlantic

The U.S. has declared (another) public-health emergency. An expert weighs in on whether we might botch this one, too.

 

Democratic lawmakers introduce bill to make reproductive health care more accessible to women with disabilities

Brad Dress, The Hill

Democratic lawmakers introduced legislation on Thursday to assist Americans with disabilities seeking reproductive health services, hoping to reduce the barriers they may face after the U.S. Supreme Court overturned Roe v. Wade and the constitutional right to abortion.

 

‘A movie set’: Former supervisor at baby formula plant says flaws were hidden

Helena Bottemiller Evich, Politico

A former supervisor in a baby formula plant linked to infant deaths earlier this year — now at the center of an ongoing formula shortage — has stepped forward to describe a facility with constant roof leaks, lax food safety and recordkeeping, and a culture of fear, raising new questions about why such problems were allowed to continue and the FDA did not discover them earlier.

 

Man Who Threatened to Kill Fauci Is Sentenced to 3 Years in Prison

Vimal Patel, The New York Times

The man, Thomas Patrick Connally Jr., 56, had pleaded guilty in May to making threats against a federal official and also admitted to sending threatening messages to other health officials, including Francis Collins, the former director of the National Institutes of Health, according to the U.S. Attorney’s Office in Maryland.

 

Democrats double down on abortion rights after Kansas referendum

Stephanie Akin and Mary Ellen McIntire, Roll Call

Democrats seeking to retain control of Congress are doubling down on the need for abortion rights after Kansas voters resoundingly defeated a ballot measure that would have made it easier for state lawmakers to restrict the procedure.

 

Some lab techs refuse to take blood from possible monkeypox patients, raising concerns about stigma and testing delays

Elizabeth Cohen and Danielle Herman, CNN

Many technicians at Labcorp and Quest Diagnostics, two of the largest commercial labs in the US, have been refusing to draw blood from patients who might have monkeypox, CNN has learned.

 

Heart medications can be a huge financial strain, but the reconciliation bill could help

Berkeley Lovelace Jr., NBC News

Tens of millions of Americans have heart disease, and for older adults, the strain can be particularly acute.

 

Polio found in sewage samples outside New York City suggests it’s spreading in the community, health officials says

Spencer Kimball, CNBC

Polio has been found in wastewater samples taken from two counties outside of New York City indicating the virus is spreading in the community, according to state health officials.

 

Legionnaires’ disease outbreak leads to one death, 11 hospitalizations in Northern California

Zach Schonfeld, The Hill

An outbreak of Legionnaires’ disease in Napa County, Calif., over the past month resulted in the death of one person and the hospitalization of 11 others, health officials said.

 

As monkeypox strikes gay men, officials debate warnings to limit partners

Fenit Nirappil and Amrita Jayakumar, The Washington Post

As the Centers for Disease Control and Prevention weighs whether to recommend limiting sexual partners, health officials in San Francisco, Chicago, New York and other U.S. cities battling surges disproportionately sickening gay men are avoiding calls for sexual restraint, wary of further stigmatizing same-sex intimacy.

 

One in 5 people waiting for a transplant are Latino. There’s a call for more donors.

Erika Flores et al., NBC News

August is National Minority Donor Awareness Month, and organizations are calling attention to the gap between the number of minority donors and those who need organs and tissues.

 
Payers
 

HCSC plans another record year of Medicare Advantage expansion

Paige Minemyer, Fierce Healthcare

The insurer said this week that will offer Medicare coverage in more than 150 new counties in five states: Illinois, Montana, New Mexico, Oklahoma and Texas. The expanded footprint will boost coverage options for as many as 1.1 million Medicare-eligibles, according to the announcement.

 

Congress eyes faster Medicare Advantage prior authorizations

Maya Goldman, Modern Healthcare

Providers may soon find it easier to get prior authorization decisions from Medicare Advantage plans under legislation moving through Congress.

 

Abortions Covered by Nearly Half of Surveyed Employer Plans

Sara Hansard, Bloomberg Law

Nearly half of more than 200 employers surveyed cover medically required and elective abortions for employees and dependents under their medical plan, according to a survey released Thursday.

 
Providers
 

AHA asks federal court to closely scrutinize how CMS repays hospitals over 340B payment cuts

Robert King, Fierce Healthcare

Hospitals that weren’t affected by cuts to the 340B drug discount program shouldn’t be required to repay any of those funds now that the Supreme Court ruled such cuts were unlawful, a key industry group said. 

 

Fitch downgrades CHS from stable to negative after discouraging earnings report

Hailey Mensik, Healthcare Dive

For the first half of the year, the chain reported a $327 million net loss and $6.04 billion in revenue, compared to a $58 million net loss and $6.02 billion in revenue during the first half of last year.

 

Sutter Health’s rising expenses and rough investments yield a $457M net loss for Q2 2022

Dave Muoio, Fierce Healthcare

The Sacramento-based nonprofit health system brought in $3.49 billion in total operating revenues from the quarter, down slightly from the prior year’s $3.51 billion.

 

Hospitals have low level of accountability for connected device breaches

Rebecca Pifer, Healthcare Dive

Hospitals are not taking basic security actions and have low levels of accountability regarding cyberattacks, ransomware and data theft stemming from breached medical devices, new research suggests.

 

Louisiana Abortion Providers Seek to Halt Newly Revived Bans

Mary Anne Pazanowski, Bloomberg Law

An abortion provider in Louisiana Thursday asked the state’s top court to reinstate a trial court decision blocking enforcement of laws prohibiting almost all abortions in the state.

 
Pharma, Biotech and Devices
 

Democrats’ drug pricing bill could lead to higher launch prices

Caitlin Owens, Axios

Democrats’ party-line drug pricing legislation will likely cause manufacturers to raise the launch prices of new drugs, the Congressional Budget Office projected yesterday.

 

Eli Lilly cuts annual profit view as lower insulin prices hit Q2 sales

Reuters

Eli Lilly and Co (LLY.N) on Thursday cut its full-year profit forecast for the second time as lower insulin prices and competition for the company’s cancer drug bruised its second-quarter earnings.

 

Tennessee sues Walgreens pharmacy chain over opioid distribution

Steve Gorman, Reuters

The state of Tennessee sued Walgreens on Wednesday, accusing the retail pharmacy giant of fueling the state’s opioid epidemic by willfully flooding the market with an oversupply of prescription narcotics in violation of consumer protection and public nuisance laws.

 

State ‘Personhood’ Laws Threaten Embryonic Stem Cell Research

Jeannie Baumann, Bloomberg Law

Biomedical scientists using embryonic stem cells or fetal tissue could find their studies at risk in conservative states aiming to redefine personhood after the US Supreme Court’s rollback of abortion rights.

 

New research digs into the genetic drivers of heart failure, with an eye to precision treatments

Elizabeth Cooney, Stat News

When coronary arteries are blocked, starving the heart of blood, there are good medications and treatments to deploy, from statins to stents. Not so for heart failure, the leading factor involved in heart disease, the top cause of death worldwide.

 

U.S. FDA declines to approve expanded use of Acadia’s antipsychotic drug

Reuters

The U.S. Food and Drug Administration declined to approve expanded use of Acadia Pharmaceuticals Inc’s (ACAD.O) antipsychotic drug for treating psychosis related to Alzheimer’s disease, the company said on Thursday.

 
Health Technology
 

Teladoc rival Amwell scores CVS tie-up to launch retailer’s virtual primary care service

Heather Landi, Fierce Healthcare

Telehealth company Amwell is working with CVS Health to roll out the retail drugstore giant’s new virtual primary care service.

 
Opinions, Editorials and Perspectives
 

The outsized effect of ‘modest’ price controls on pharmaceutical innovation

Standish Fleming, Stat News

Drug price controls in the U.S. Senate are being met with dire warnings that such an approach will stifle innovation, shut off the pipeline of new medicines, and cost lives down the road. Is innovation so fragile that a modest reduction in profits of global giants could seriously impact the supply of new drugs?

 
Morning Consult