About Covid-19
England’s public health body investigates new offshoot of Omicron: “An offshoot of the Omicron coronavirus variant, known as BA.2, is being investigated by England’s public health body over concerns that it may be even faster spreading than the original version. The UK Health Security Agency said it was designating the Omicron offshoot a ‘variant under investigation’ because of ‘increasing numbers of BA.2 sequences identified both domestically and internationally’. Early analysis suggests the BA.2 sub-variant may have an ‘increased growth rate’ over the earlier form of Omicron, officially designated as BA.1, according to UKHSA, which stressed that there is a ‘low level of certainty early in the emergence of a variant’. Moreover, BA.2 has not been named a ‘variant of concern’ — the highest risk ranking for new strains.”
Omicron Pressure Eases in Some U.S. States, but Infections Remain High: “The seven-day average of total people in U.S. hospitals declined for the second consecutive day, reaching 158,788 on Saturday, according to data from the Department of Health and Human Services. The number of new admissions to hospitals across the U.S. was also down.”
Still, some states remain in crisis (see the article’s map of average daily cases per 100K).
White House launches call line for free COVID-19 test orders: Starting last Friday, Americans who could not order “the COVID-19 tests on the website launched by the White House… can call 1-800-232-0233 to do so… The call line, which serves those speaking English, Spanish and more than 150 additional languages, is open 8 a.m. until midnight EST, seven days a week.
The Biden administration has also set up a text-based line for hearing-impaired callers at 1-888-720-7489.”
FDA expands use of remdesivir to patients with high risk of hospitalization: “The U.S. health regulator on Friday expanded its approval for the use of Gilead Sciences' antiviral drug remdesivir to treat non-hospitalized patients 12 years and older for the treatment of mild-to-moderate COVID-19 disease with high risk of hospitalization.”
Comparison of mRNA-1273 and BNT162b2 Vaccines on Breakthrough SARS-CoV-2 Infections, Hospitalizations, and Death During the Delta-Predominant Period: “Immune responses to mRNA-1273 (Moderna) and BNT162b2 (Pfizer-BioNTech) vaccines decline by 6 months after vaccination, although antibody titers are higher with mRNA-1273…
This study found that recipients of mRNA-1273 compared with BNT162b2 had a lower risk of breakthrough SARS-CoV-2 infections and hospitalizations during the Delta period.”
WHO Recommends Extending Use of Pfizer/BioNTech COVID-19 Jab to 5-11 Year Olds: “The advisory panel recommended a 10-microgram dose, one-third of the full 30-microgram dose for older children and adults, but did not did not make a recommendation about offering booster doses to young children.”
Trends in US Ambulatory Care Patterns During the COVID-19 Pandemic, 2019-2021: “In this retrospective cohort study that included more than 14.5 million patients, there was an overall increase in the return to expected rates of use of 6 ambulatory care services between March 2020 and February 2021. This increase was significantly lower for patients with Medicaid or those with Medicaid-Medicare dual eligibility than for those with commercial, Medicare Advantage, or Medicare fee-for-service.”
Cannabidiol inhibits SARS-CoV-2 replication through induction of the host ER stress and innate immune responses: “Here we report that cannabidiol (CBD) inhibits infection of SARS-CoV-2 in cells and mice. CBD and its metabolite 7-OH-CBD, but not THC or other congeneric cannabinoids tested, potently block SARS-CoV-2 replication in lung epithelial cells. CBD acts after viral entry, inhibiting viral gene expression and reversing many effects of SARS-CoV-2 on host gene transcription…This study highlights CBD as a potential preventative agent for early-stage SARS-CoV-2 infection and merits future clinical trials. We caution against use of non-medical formulations including edibles, inhalants or topicals as a preventative or treatment therapy at the present time.” [Emphasis added]
Los Angeles school district tells students to upgrade from cloth masks: “The Los Angeles Unified School District is prohibiting students from wearing only cloth face masks on campus as the country grapples with a continued surge of COVID-19 infections driven by the omicron variant.
The district announced updated guidance on Friday requiring students to wear "well-fitting, non-cloth masks with a nose wire" both indoors and outdoors. Employees will have to wear surgical grade masks or higher.
Students and employees will be able to get masks from the district if they need them.”
Changes in COVID-19 Vaccine Hesitancy Among Black and White Individuals in the US: “This survey study of 1200 US adults found that COVID-19 vaccine hesitancy decreased more rapidly among Black individuals than among White individuals since December 2020. A key factor associated with this pattern seems to be the fact that Black individuals more rapidly came to believe that vaccines were necessary to protect themselves and their communities.”
About pharma
New clinical trial organization launches with promise to conduct randomized trials at fraction of the cost: “Protas emerged Monday with Sanofi signed on as a strategic partner, and the company's overall goal is to design smarter trials that leverage new technologies and collaborations. The organization will be led by Prof. Sir Martin Landray, a 20-year veteran of conducting large clinical trials at Oxford University’s Nuffield Department of Population Health.”
Senators Propose Bill to Balance FDA’s Domestic, Foreign Inspections Requirements: “Sens. Joni Ernst (R-Iowa) and Mike Braun (R-Ind.) have introduced a bill to eliminate the advance notice foreign drugmakers receive before an FDA inspection to level the playing field for domestic companies that don’t typically receive any such prenotification.
The Creating Efficiency in Foreign Inspections Act is meant to do away with the incentive drug manufacturers have to keep their facilities abroad and urge pharma companies to ship their plants back to the U.S. to strengthen the supply chain.”
FDA’s Maintains Stable Performance Across PDUFA and BsUFA Tasks During the Pandemic: “Despite the pandemic, the FDA’s product review performance as it related to the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Amendments (BsUFA) remained relatively stable through fiscal year 2020 to fiscal year 2021, according to the latest data posted on the agency’s ‘dashboard’ — which tracks how well the agency is living up to its review commitments under the user fee programs.”
Capital Rx and Independa Partner to Bring Prescription Savings to the Masses via LG Televisions: “LG TV customers can access the Capital Rx prescription savings card through their Independa services on LG TVs, or via downloading the Independa mobile app, all free, to begin saving up to 90% on prescription costs.
Capital Rx Advantage savings card accepted at 65k pharmacies and major retailers, including Walgreens, Walmart, Costco and more.”
UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile: “It will give patients earlier access to innovative treatments by allowing greater flexibility over decisions about value for money and consideration of a broader evidence base. The new assessment will also provide greater predictability for industry, greater transparency for patients and enable swift decision making for NICE’s independent committees, NICE said in a statement.
One key addition will be a weighting the severity of diseases, intended to provide more equitable access to treatments. Currently, a similar approach is taken — insomuch as a higher price threshold is offered — only for medicines used at the end of life.
NICE will also take greater account of real-world evidence and consider uncertain benefits for treatments for rare diseases and children’s medicines, for example, where evidence can be harder to gather. NICE said it wants to ensure valuable innovations in these areas are made available while managing potential risks to patients. Its decisions apply to England and Wales and are often adopted in Northern Ireland.”
Comment: NICE is often used a s benchmark for “enlightened,” evidence-based decisions on use of drugs and healthcare technology.
About the public’s health
Exclusive-U.S. opposes plans to strengthen World Health Organization: “The United States, the World Health Organization's top donor, is resisting proposals to make the agency more independent…
The proposal, made by the WHO's working group on sustainable financing, would increase each member state's standing annual contribution…
The plan is part of a wider reform process galvanised by the COVID-19 pandemic, which has highlighted the limitations of the WHO's power to intervene early in a crisis.
But the U.S. government is opposing the reform because it has concerns about the WHO's ability to confront future threats, including from China, U.S. officials told Reuters.
It is pushing instead for the creation of a separate fund, directly controlled by donors, that would finance prevention and control of health emergencies.”
About healthcare IT
IBM Watson Health data sale to include imaging and public health software: More information about the previously reported sale.
Telehealth heavy hitters join new advocacy group: “The American Telemedicine Association has partnered with telehealth organizations to form an advocacy group.
The organization, ATA Action, will work to advocate for telehealth policy and expand policy gains made during the COVID-19 pandemic… The trade organization supports action at the state and federal levels to ensure individuals have access to telemedicine, including appropriate coverage and payment policies.”
Global digital health funding skyrockets to $57.2B with record cash for mental health, telehealth: “Digital health investment around the world hit an all-time high of $57.2 billion in funding in 2021, fueled by the growing need to provide digital solutions and delivery models to patients during the pandemic.
The record-breaking funding marks a 79% jump from the $32 billion raised globally in 2020, according to a year-end report by market intelligence firm CB Insights.
That record amount was raised in 2,930 deals, compared to 2,518 deals in 2020.”
Woman charged $847 'facility fee' for telehealth visit: “Brittany Tesso, a mother in Colorado, was recently charged $847.35 for a "facility fee" for her 3-year-old son's telehealth visit at Aurora-based Children's Hospital Colorado, KDVR reported Jan. 23.
She also received a bill of $676.86, which she paid. Her son's visit was to see if he needed speech therapy.
‘I was like, “Facility fee? I didn't go to your facility. I was at home and as far as I could tell some of the doctors were at home too.” And [a hospital representative] said, “Well, we charge the same whether you come to the facility or it's a telehealth appointment,”’ Ms. Tesso told KDVR.’”
About healthcare personnel
Rich Countries Lure Health Workers From Low-Income Nations to Fight Shortages: Not a new problem, but it has been exacerbated by global labor shortages due to the Covid pandemic. The article provides some good examples of this practice.
Health-Care Strike Risk Runs High as Hundreds of Labor Deals End: “Hundreds of union contracts will expire in 2022 at health-care facilities from Boston to Sacramento, setting up fights over staff-to-patient ratios, pay, and other safety concerns as beleaguered workers continue to battle the Covid-19 pandemic.
The cluster of expiring labor agreements will force health-care management to reckon with the physical and mental toll the pandemic has had on workers during the worst staffing shortage in memory.
At least 207,000 health-care workers are covered by the more than 400 labor agreements set to expire this year, according to an analysis of federal disclosures and contract settlement data compiled by Bloomberg Law. That figure is a conservative estimate that will only grow throughout the year as more companies report information on expiring contracts to the federal government.”