About Covid-19
Israeli panel recommends fourth Covid vaccine dose for all adults: “Israel’s vaccine advisory panel has recommended a fourth dose of a Covid-19 shot for all adults [over 18], a world first, as the country battles a surge in infections driven by the Omicron coronavirus variant. The move fol”lows research showing fourth doses doubled protection against symptomatic Covid-19 and increased protection against severe illness by three to five times, compared with three doses. Other countries, including the UK, US and Chile, have signed off on fourth doses for immunocompromised people, such as those living with HIV or certain transplant recipients, but have hesitated on launching a widescale second booster campaign.”
OSHA withdraws its workplace vaccine rule.: “The Biden administration is withdrawing its requirement that large employers mandate workers be vaccinated or regularly tested, the Labor Department said on Tuesday.
In pulling the rule, the department recognized what most employers and industry experts said after a Supreme Court ruling this month — that the emergency temporary standard could not be revived after the court blocked it.”
BiologyWorks COVID-19 Test Achieves 99.1 Percent Accuracy in Study: “Los Angeles, Calif.-based startup BiologyWorks said its handheld, reusable molecular-testing device for COVID-19 matched the 99.1 percent accuracy seen in polymerase chain-reaction (PCR) tests in a clinical trial…
The molecular test has multiple possible applications, including identifying infections, such as influenza A/B, hepatitis B, Streptococcus, sexually transmitted diseases, pneumonia and even cancers, the company said.”
Biden administration seeks Medicare coverage of at-home COVID-19 tests: “The administration has received pressure from lawmakers and researchers to expand coverage, and some health insurers have decided to broaden coverage beyond the federal requirements, which were outlined Jan. 10.”
Multiple Early Factors Anticipate Post-Acute COVID-19 Sequelae [PASC]: “We resolved four PASC-anticipating risk factors at the time of initial COVID-19 diagnosis: type 2 diabetes, SARS-CoV-2 RNAemia, Epstein-Barr virus viremia, and specific autoantibodies. In patients with gastrointestinal PASC, SARS-CoV-2-specific and CMV-specific CD8+ T cells exhibited unique dynamics during recovery from COVID-19.”
Hospitals are denying transplants for patients who aren’t vaccinated against Covid, with backing from ethicists: “Perhaps because of the politicization of Covid-19 vaccines more broadly, the reaction to such decisions is sometimes greeted with outrage. But ethicists and transplant physicians stress that organ allocation has to be partially determined by who can survive and thrive with a scarce resource. With so many people waiting for an organ, clinicians try to maximize the chances of a successful transplant. Hospitals don’t want to allocate an organ to people who are putting themselves at higher risk of dying after a transplant — especially since that organ can’t then go to someone else.
About health insurance
Anthem reports $1.1B in profit for Q4, doubling its haul year over year: “The results beat Wall Street, according to analysts from Zacks Investment Research. Anthem did fall short of Street expectations on revenue for the quarter, however, posting $36.6 billion, though that does represent a 14.9% increase from its fourth-quarter 2020 haul of $31.8 billion.
The insurer brought in $6.1 billion in profit for full-year 2021, up from $4.6 billion in 2020. Full-year revenues were $138.6 billion, according to the company's earnings report released Wednesday.”
Insurers missing the mark on mental health parity, new federal report says: “Mental health parity laws require that insurers cannot impose financial requirements or treatment limitations on mental health care that exceed those on physical care services. The report, issued by the departments of Labor, Health and Human Services (HHS) and Treasury to Congress, found many insurers are failing in this regard…
The Employee Benefits Security Administration has issued 156 letters across 86 investigations, according to the report. The Centers for Medicare & Medicaid Services has also issued 15 letters between May and November 2021 in states where it has authority over mental health parity, namely Texas, Missouri and Wyoming, as well as to nongovernmental plan sponsors.”
About hospitals and healthcare systems
Curb costs or get fined, state tells Mass General Brigham: “Boston-based Mass General Brigham must develop a performance improvement plan to reduce costs after the state's healthcare watchdog determined that the health system pushed healthcare spending above acceptable levels throughout the last few years…
The Massachusetts Health Policy Commission found that Mass General Brigham had substantially higher than average commercial spending from 2014 to 2019. In total, the health system had $293 million in total spending across those years, which was more than any other provider. The commission said this high level of spending that stems from the system's expensive care has hurt the state's ability to control healthcare costs and meet the state's affordability benchmarks.
Failure to comply comes with a $500,000 fine, according to the commission's website.”
About pharma
New Drug Application (NDA): The FDA has proposed updated rules for its 21 year-old Abbreviated NDA labeling requirements after revisions to the approved labeling of a reference listed drug (RLD) on which a generic drug is based.
Big Insulin Makers Spent Big Money on Lobbying in 2021: “ According to lobbying disclosures, Eli Lilly shelled out $7 million on lobbying in 2021, which represents an almost 30 percent increase over 2020, but was similar to what the company spent in 2019.
Another big maker of insulin, Novo Nordisk, spent $3.2 million, almost a quarter more than in 2020.”
Trulicity Instagram post draws OPDP’s first untitled letter of 2022: “In an untitled letter dated 19 January 2022, the US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) cites drugmaker Eli Lilly for a social media post about its type 2 diabetes mellitus drug Trulicity (dulaglutide).
According to the untitled letter, an Instagram post with a video component promoting Trulicity failed to adequately present the drug’s FDA-approved indication and limitations of use. It also failed to include “material information” about the risk of hypoglycemia with concomitant insulin use.
The post contains multiple frames with text stating “Make every moment count,” and ‘Trulicity may help lower A1C*’ but does not prominently display information about the drug’s indication, limitations of use or risk information.”
J&J's drug sales rise 16.5% in Q4, boosted by COVID-19 vaccine: “Johnson & Johnson said that it expects sales of its COVID-19 vaccine Ad26.COV2.S to be between $3 billion and $3.5 billion this year, up from $2.4 billion in 2021, which topped analyst forecasts of $1.5 billion.
The company noted that including sales of the coronavirus vaccine, revenue this year is seen between $98.9 billion and $100.4 billion, representing growth in the range of 5.5% to 7%. Analysts estimate full-year sales of around $97.8 billion. Meanwhile, earnings per share are predicted to be between $10.40 and $10.60.”
About healthcare personnel
COVID-Related Stress and Work Intentions in a Sample of US Health Care Workers: “Among 20,665 respondents at 124 institutions (median organizational response rate, 34%), intention to reduce hours was highest among nurses (33.7%; n=776), physicians (31.4%; n=2914), and advanced practice providers (APPs; 28.9%; n=608) while lowest among clerical staff (13.6%; n=242) and administrators (6.8%; n=50; all P<.001). Burnout (odds ratio [OR], 2.15; 95% CI, 1.93 to 2.38), fear of exposure, COVID-19–related anxiety/depression, and workload were independently related to intent to reduce work hours within 12 months (all P<.01)…
Conclusion: Approximately 1 in 3 physicians, APPs, and nurses surveyed intend to reduce work hours. One in 5 physicians and 2 in 5 nurses intend to leave their practice altogether.”
About health technology
Patient Engagement in the Design and Conduct of Medical Device Clinical Studies: Today, the FDA issued this document to encourage patient feedback in the design of medical devices and clinical trials to prove their efficacy. “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.”
The reason for these suggestions is that the “FDA believes medical device clinical studies prospectively designed with input from diverse patient advisors, including those from racially and ethnically diverse populations, may help to address common challenges faced in these clinical studies and could result in:
Faster study/research participant recruitment, enrollment, and study completion;
Greater study/research participant commitment and retention, resulting in decreased loss
to follow-up;
Greater study/research participant adherence resulting in fewer protocol
deviations/violations;
Greater study/research participation by diverse patient populations;
Fewer protocol revisions;
Streamlined data collection resulting in better quality data; and
More relevant data on outcomes that matter to patients.”
Abbott weathers 2021’s COVID-testing roller coaster ride with $7.7B in annual diagnostic sales: “For the full year, the medtech giant reported total COVID test sales of $7.7 billion. The fourth quarter of 2021 brought in more than its fair share of those earnings, with $2.3 billion, though it fell short of the same three-month period in 2020 when Abbott raked in about $2.4 billion from its coronavirus offerings.
Still, 2021’s earnings massively dwarfed those of 2020, which saw total COVID-related sales of about $3.9 billion between the second and fourth quarters.”
About healthcare finance
Health-Stock Drubbing Gets Uglier in Longest Drop Since 1994: “Amid concerns about rising rates and a broader market rout, the sector has dropped more than 9% so far in January and is also poised for its worst monthly plunge since 2009. That compares with a 24% jump last year.
Investors have been turning away from pandemic stock winners as the market gets more optimistic that Covid-19 will be tamped down to a more manageable virus like the flu. Caught in the economic reopening trade are the scientific tools and service stocks that outperformed last year and of course vaccine makers including Pfizer Inc. and Moderna Inc.”