About Covid-19
'Unthinkable tragedy': U.S. COVID-19 death toll surpasses 1 million The headline, unfortunately, speaks for itself.
U.S. will share COVID-19 vaccine technology, Biden tells global summit “The United States will share technologies used to make COVID-19 vaccines through the World Health Organization and is working to expand rapid testing and antiviral treatments for hard-to-reach populations, President Joe Biden said on Thursday.
Speaking at the second global COVID-19 summit, Biden called on Congress to provide additional funds so that the U.S. may contribute more to the global pandemic response.”
COVID-19:FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed “GAO was asked to review FDA's oversight of tests for COVID-19. This report examines, among other things, 1) the actions FDA took to help make COVID-19 tests available for use, 2) the number of tests FDA authorized and those for which it exercised enforcement discretion, and 3) FDA's monitoring of these tests after they were available for use…
[The GAO recommends that the] Commissioner of FDA should develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies. This policy should include the conditions under which FDA would begin and end the use of such discretion.”
About health insurance
Medicare Spending on Prescription Drugs Far Outpaces Development Costs “The AARP report also cited 2021 data from the U.S. House of Representatives Committee on Oversight and Reform, which found that from 2016 to 2020, the 14 leading drug companies spent $577 billion on stock buybacks and dividends—$56 billion more than they spent on R&D over the same period. The $2.6 billion average cost of development, Purvis said, is an industry-generated estimate and other researchers have challenged that figure as too high.”
About hospitals and healthcare systems
Top teaching hospitals by net patient revenue FYI
Concordance of Hospital Ranks and Category Ratings Using the Current Technical Specification of US Hospital Star Ratings and Reasonable Alternative Specifications “In this cross-sectional study of data on 3339 US hospitals, on average half were assigned a different star rating when using reasonable alternatives to the current methods. Different changes to the technical specification had differential outcomes, but even minor changes in specification could lead to substantial reclassification between adjacent performance categories.”
Adverse Events in Hospitals: A Quarter of Medicare Patients Experienced Harm in October 2018 Released a few days ago from the HHS OIG. While the full report is worth reading, the following are some key findings:
”Twenty-five percent of Medicare patients experienced patient harm during their hospital stays in October 2018. Patient harm includes adverse events and temporary harm events.
Twelve percent of patients experienced adverse events, which are events that led to longer hospital stays, permanent harm, life-saving intervention, or death. In addition to the patients who experienced adverse events, 13 percent of patients experienced temporary harm events, which required intervention but did not cause lasting harm, prolong hospital stays, or require life-sustaining measures. Temporary harm events were sometimes serious and could have caused further harm if providers had not promptly treated patients.
Categories of Harm Events. The most common type of harm event was related to medication (43 percent), such as patients experiencing delirium or other changes in mental status. The remaining events related to patient care (23 percent), such as pressure injuries; to procedures and surgeries (22 percent), such as intraoperative hypotension; and to infections (11 percent), such as hospital-acquired respiratory infections.”
Recommendations are also offered.
U.S. Not-for-Profit Hospitals and Health Systems Face Mounting Operating Stress (Pandemic, Labor and Inflation Pressures to Persist Through 2022 and Beyond) “The entire burden of any business interruption and negative margin impact due to coronavirus is now borne fully by providers. NFP healthcare is a low-margin sector, and Fitch Ratings expects operating margins will weaken in 2022. Lower margins are still currently offset by strong balance sheets, which have provided a generous cushion over the last two years of operating uncertainty. Pressures are anticipated to be within the expected range of volatility for the sector, and we do not foresee any significant deterioration of rated healthcare providers’ financial positions at this time. Our sector outlook remains neutral; however, another omicron-like surge this fall/winter may see this cushion materially eroded, and signal the beginning of downward rating momentum across the sector.”
The study was probably done before the recent stock market “correction,” so the statement about strong balance sheets may no longer be quite so accurate.
About pharma
Three UK pharma companies go broke, costing 1,000 employees their jobs: reports “Three large U.K. pharmaceutical companies are in financial trouble and are shutting down, costing about 1,000 employees their jobs, according to local reports.
Testerworld, Doncaster Pharmaceuticals Group and Eclipse Generics are all part of the Converse Pharma Group, a U.K. group of companies founded in 2013 that focuses on wholesale distribution. The companies have entered into administration, a program to either rescue a company or wind down its operations, according to several reports in England.”
New Japan-originated ALS treatment option available to patients in the U.S.―FDA approval of RADICAVA ORS for the treatment of ALS “Mitsubishi Tanabe Pharma Corporation…a member of the Mitsubishi Chemical Holdings Group, announced that the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS® (edaravone) for the treatment of amyotrophic lateral sclerosis (ALS) on May 12, 2022.”
About the public’s health
The baby formula shortage has turned political A really good review of this problem from the Washington Post.
Estimating the Burden of Influenza-like Illness on Daily Activity at the Population Scale Using Commercial Wearable Sensors “Question How can the true burden of influenza-like illnesses (ILIs) be estimated given that most cases of ILIs are mild and go undocumented?
Findings This cohort study of 15 122 adults who reported ILI symptoms and had data from wearable sensors at symptom onset found an overall reduction in mobility equivalent to 15% of the active US population becoming completely immobilized for 1 day. More than 60% of this reduction occurred among persons who had sought no medical care.
Meaning This study suggests that the burden of ILIs is much greater than had previously been understood.”
About healthcare IT
Interoperability Workgroup Report From the Health Innovation Alliance:
“Six areas of focus were identified:
Data That Works for Patients and Providers at the Point of Care
Leverage State of the Art Medical Devices to Improve Patient Care
Clear Protections from HIPAA Penalties for Patient Information Requests
Inform Medical Research and Innovation with Better Information
Social Determinants of Health, and
Improve Public Health Data Collection and Reporting”
The report makes 21 recommendations covering these categories and also assigns responsibility for their implementation and monitoring, e.g., Congress, FDA, ONC, and CMS.
IoT in Healthcare Market “The global IoT in healthcare market is projected to reach US$ 181.4 Billion in 2022, anticipated to grow at a CAGR of 18.0%, reaching US$ 952.3 Billion by 2032. The market is slated to document a Y-o-Y growth rate of 20.7% from 2021-2022, increasing from the previously registered value of US$ 150.3 Billion.”
Legacy Devicemakers Must Still Support Cybersecurity, IMDRF Says “Manufacturers of legacy devices that were not designed with cybersecurity in mind must tell customers during the procurement process when they will stop providing cybersecurity support, the International Medical Device Regulators Forum (IMDRF) advises in a just-published draft document.”
About healthcare personnel
Michigan grants full practice authority for CRNAs “Michigan is the 20th state to allow certified registered nurse anesthetists to practice without physician supervision after Gov. Gretchen Whitmer signed a bill into law granting full practice authority for those providers…”
About health technology
Paige nets European OK for AI to spot prostate cancer biomarkers Usually biomarker identification requires special tissue stains or genetic analysis. This AI technology can pick up 4 prostate cancer biomarkers using the usual tissue stains.
FDA clears BD’s newest molecular diagnostics machine and its first test, a three-in-one STI screener “The medtech giant recently landed the FDA’s clearance for the third component in its Cor diagnostics platform, it announced this week, and has already begun the launch of the new BD Cor MX instrument throughout the U.S.
The MX system joins the previously cleared PX and GX instruments on the Cor platform…
Alongside the launch of the MX component, BD was also given the green light to roll out the instrument’s first assay: a three-in-one test that simultaneously looks for the most common non-viral sexually transmitted infections at once, including chlamydia, gonorrhea and trichomoniasis.”
GE Healthcare aims to bring prenatal ultrasound to the home, with investment in smartphone-scanner developer “GE Healthcare and the handheld ultrasound developer Pulsenmore aim to give expectant parents the opportunity to chart their pregnancies at home and perform the scans themselves.
Pulsenmore’s device docks with a smartphone, allowing women to conduct their own exams and potentially skip an in-person doctor’s visit. The user can be guided online through a telehealth service or offline by following the steps in an app.
The Israeli startup aims to offer fast clinical feedback for periodic fetal ultrasound scans, and GE Healthcare is now supporting the company through an equity investment worth up to $50 million—to help the medtech enter what it describes as a rapidly expanding market of homecare and telemedicine services.”
Researchers uncover the brain's link to SIDS, setting up potential infant screening test “Researchers in Australia have uncovered the first chemical biomarker tied to sudden infant death syndrome, widely known as SIDS, which could help lead to a test that can screen for babies at risk for the tragic condition…
’An apparently healthy baby going to sleep and not waking up is every parent’s nightmare, and until now, there was absolutely no way of knowing which infant would succumb. But that’s not the case anymore,’ said lead researcher Carmel Harrington, M.D., an honorary fellow at The Children's Hospital at Westmead in Sydney, who lost her own child to SIDS 29 years ago.
Her team identified the nervous system enzyme butyrylcholinesterase as a strong marker of risk. Dubbed BChE for short, the chemical plays an active role in the brain’s ability to wake up the body from sleep in response to difficulty breathing or another stimulus.”
See this site for the original research article.
About healthcare finance
Trends in Real Estate Investment Trust Ownership of US Health Care Properties “In 2021, REITs owned 197 (3%) of all hospitals and 1870 (12%) of all skilled nursing facilities. Real estate investment trust hospital acquisitions have increased during the past 15 years until the COVID-19 pandemic, during which acquisitions were minimal. In a multivariate logistic analysis, some of the characteristics most strongly associated with REIT ownership were for-profit status (odds ratio, 25.05; 95% CI, 14.69-42.70; P < .001) and urban status (odds ratio, 6.8; 95% CI, 1.61-28.67; P = .01)."