HHS Secretary Becerra Establishes ARPA-H within NIH, Names Adam H. Russell, D.Phil. Acting Deputy Director “Health and Human Services Secretary Xavier Becerra… announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health and the appointment of Adam H. Russell, D.Phil., as acting deputy director…
With broad technical and management experience across several disciplines, ranging from cognitive neuroscience and physiology to cultural psychology and social anthropology, Dr. Russell will guide the early stages of building the administrative structure of the agency and oversee the hiring of initial operational staff to ensure the agency is stood up as effectively and efficiently as possible. President Biden will appoint an ARPA-H Director who will be responsible for administration and operation of ARPA-H and will report to the HHS Secretary.”
About Covid-19
As summer begins, US COVID-19 cases six times higher than last year “As the US marks Memorial Day weekend and the unofficial start of summer, the seven-day average for COVID-19 cases in the U.S. are more than six times what they were a year ago.
The Johns Hopkins Coronavirus Resource Center showed a seven-day average of 119,725 cases as of Saturday. That figure held at 17,887 cases on May 28 of last year…
The seven-day average of 470 deaths reported on Friday marked a decrease from 637 on the same day last year.”
About health insurance
Medicare recipients to see premium cut — but not until 2023 “Medicare recipients will get a premium reduction — but not until next year — reflecting what Health and Human Services Secretary Xavier Becerra said Friday was an overestimate in costs of covering an expensive and controversial new Alzheimer’s drug.
Becerra’s statement said the 2022 premium should be adjusted downward but legal and operational hurdles prevented officials from doing that in the middle of the year. He did not say how much the premium would be adjusted.”
About hospitals and healthcare systems
National Hospital Flash Report: May 2022 Among the highlights:
—”The median Kaufman Hall Year-To-Date (YTD) Operating Margin Index reflecting actual margins was -3.09% through April.
The median change in Operating Margin was down 38.1% from last month and 76% from April 2021…
—Patient Days were down 5.7% month-over-month and 1.8% compared to April 2021. Adjusted Patient Days dropped 6.5% from March to April but were up 1.8% compared to April 2021…
—Volume lags resulted in poor revenue performance in April. Gross Operating Revenue was down 7% from March and Outpatient (OP) Revenue dropped 7% from March levels. However, Gross Operating Revenue is up 6.6% YTD, while OP Revenue is up 8.5% YTD. Similarly, Inpatient Revenue dropped 7.1% from the previous month and is up 5.3% this year…
—Total Expenses remained high in April, dropping only 4.3% from March. Expenses have continued to rise compared to 2020 and are well above pre-pandemic levels. As labor shortages and supply chain challenges continued, Total Expenses grew by 8.3% YOY and 9.6% YTD…
—The emergency department is no longer the hospital’s front door.
More patients are seeking care outside of the hospital, choosing urgent care centers, telemedicine, and even primary care providers instead of the emergency department…
—Patients are sicker and more expensive to treat.”
About pharma
The FDA is busy busting up drug counterfeiting rings—but is it doing enough to protect patients? “The FDA’s Office of Criminal Investigations staged 130 counterfeit drug busting operations between 2016 and 2021, according to a new report published in the journal Annals of Pharmacotherapy. But one expert says all of those operations ‘barely scratch the surface’ of the problem and that serious safety risks remain…
All told, about 65% of the FDA’s enforcement actions centered on phony products sold over the internet. In about 85% of the FDA’s operations, patients could obtain the counterfeit drugs—often controlled substances like opioids, stimulants and benzodiazepines—without a prescription…”
The top 20 drugs by worldwide sales in 2021 FYI. No surprise, #1 is Comirnaty (Pfizer/BioNTech’s Covid 19 vaccine). #2 is Humira.
Amgen's Neulasta faces more competition as FDA okays another biosimilar “Amneal Pharmaceuticals announced Friday that the FDA approved Fylnetra (pegfilgrastim-pbbk), its biosilimar version of Amgen's Neulasta. In recent years, the US regulator has cleared several biosimilar competitors to Neulasta, which is used to reduce the incidence of infection associated with febrile neutropenia in patients undergoing chemotherapy.”
Each new biosimilar lowers the market charges for that drug, so any new approvals are very welcome.
GSK expands vaccine portfolio with $3.3-billion deal for Affinivax “GSK announced Tuesday a definitive agreement to acquire Affinivax for up to $3.3 billion, including an upfront payment of $2.1 billion, boosting its vaccine portfolio against pneumococcal disease. Hal Barron, GSK's chief scientific officer, said the deal ‘further strengthens our vaccines R&D pipeline, provides access to a new, potentially disruptive technology, and broadens [our] existing scientific footprint in the Boston area.’
According to GSK, Affinivax's Multiple Antigen-Presenting System (MAPS) technology ‘supports higher valency than conventional conjugation technologies, enabling broader coverage…and potentially creating higher immunogenicity than current vaccines.’ The company's lead vaccine candidate AFX3772 includes 24 pneumococcal polysaccharides plus two conserved pneumococcal proteins, while a 30-plus valent pneumococcal candidate vaccine is also in preclinical development.”
FDA Grants Fast-Track Label to Pfizer’s Combination Therapy for NASH “The FDA has handed Fast-Track designation to Pfizer’s investigational combination therapy ervogastat and clesacostat for the treatment of nonalcoholic steatohepatitis (NASH), a progressive form of nonalcoholic fatty liver disease.
The agency’s decision is based on study results showing that the ervogastat and clesacostat treatment combination led to a reduction of liver fat along with a favorable tolerability and safety profile.”
About the public’s health
Daily E-cigarette Use and the Surge in JUUL Sales: 2017–2019 “Among baseline nondaily tobacco users, only those aged 14 to 17 years had an increase in the 2-year incidence of new daily tobacco use (2014 cohort = 4.8%, 95% confidence interval 4.3, 5.5 vs 2017 cohort = 6.3%, 95% confidence interval 5.8–7.0) to rates approaching those in the 1990s. In 2019, three-quarters of new daily tobacco users aged 14 to 17 vaped daily and had e-cigarette dependence scores similar to daily cigarette smokers and older adult e-cigarette vapers. We estimate that about 600 000 Americans aged <21 years used JUUL products daily in 2019, a rate 2.5 times those aged 25 to 34 years.”
FDA investigating hepatitis A outbreak possibly linked to fresh strawberries “The FDA with the US Centers for Disease Control and Prevention, the Public Health Agency of Canada, the Canadian Food Inspection Agency and state and local partners, said the strawberries were branded as FreshKampo and HEB and purchased between March 5 and April 25.
They were distributed nationwide and sold at a number of retailers including Aldi, HEB, Kroger, Safeway, Sprouts Farmers Market, Trader Joe's, Walmart, Weis Markets and WinCo Foods.”
Association of Sugar-Sweetened, Artificially Sweetened, and Unsweetened Coffee Consumption With All-Cause and Cause-Specific Mortality “Moderate consumption of unsweetened and sugar-sweetened coffee was associated with lower risk for death.”
An accompanying editorial comments: “Unfortunately, Liu and colleagues' study does not quite get at what we really want to know. Is drinking coffee laden with sugar and calories still potentially beneficial, or at least not harmful? The coffee consumption data used in their study reflected consumption from approximately 10 years ago in a country [UK] where tea is a competing beverage. The average dose of added sugar per cup of sweetened coffee was only a little over a teaspoon, or about 4 grams. This is a far cry from the 15 grams of sugar in an 8-ounce cup of caramel macchiato at a popular U.S. coffee chain. Nonetheless, Liu and colleagues' data are reassuring in demonstrating that most study participants who drank coffee added no or only small amounts of sugar and this pattern of intake was not harmful from a mortality risk perspective and was potentially beneficial.”
Top-RatedHealthcare: The US States with the Best Healthcare “We ranked all 50 states based on five factors: % of “A” Grade Hospitals (patient safety), number of honor roll hospitals, number of hospitals in America’s top 50, hospitals per million people and staffed hospital beds per million people. These factors combined give each state a healthcare rank you can use as a guide to where you can find the best level of healthcare in the US.”
See if you agree with the rankings. For example, this methodology ranks Hawaii #47- very much lower than many other “lists.”
Austin pushing to effectively decriminalize abortion ahead of ruling on Roe “The city of Austin is attempting to shield its residents from prosecution under a Texas law that would criminalize almost all abortions if Roe v. Wade is overturned — the first push by a major city in a red state to try to circumvent state abortion policy.
Councilmember Chito Vela is proposing a resolution that would direct the city’s police department to make criminal enforcement, arrest and investigation of abortions its lowest priority and restrict city funds and city staff from being used to investigate, catalogue or report suspected abortions.”
About health technology
Medtronic, DaVita to form new kidney care company “According to a news release, the new company will bring together Medtronic’s capabilities as a healthcare technology leader and DaVita’s expertise as a comprehensive kidney care provider. The new company will focus on developing a wide range of novel kidney care products and solutions, including future home-based products to make different dialysis treatments more accessible.”