About Covid-19
Emergence in Southern France of a new SARS-CoV-2 variant of probably Cameroonian origin harbouring both substitutions N501Y and E484K in the spike protein: “Here we describe the emergence of a new variant. For twelve SARS-CoV-positive patients living in the same geographical area of southeastern France, qPCR testing that screen for variant-associated mutations showed an atypical combination. The index case returned from a travel in Cameroon.”
Israel reports world's first 'flurona' influenza-COVID double infection: “The world's first documented case of ‘flurona,’ or simultaneous infections of COVID-19 and influenza viruses, has been recorded in Israel, doctors said.
The first known case of the double infection was identified in a woman who was giving birth last week at Rabin Medical Center in Petah Tikva, Israel, the Times of Israel and the Yedioth Ahronot newspaper reported.
Hospital officials said the young mother, who was not vaccinated against either illness, did not suffer any permanent consequences and was released from the hospital on Thursday.”
Interval between Moderna COVID-19 vaccine second shot and booster still six months -FDA: “The interval between receiving a second dose of Moderna' s COVID-19 vaccine and a booster dose remains unchanged at six months, U.S. Food and Drug Administration Acting Commissioner Janet Woodcock said on Monday.
‘Right now if you got J&J you get a booster after two months, if you got Pfizer as your primary series you can get a booster at five months or beyond, if you got Moderna you can get a booster at six months or beyond whatever you decide to get a booster of,’ Woodcock said on a press call.”
Paradoxical sex-specific patterns of autoantibody [AAB] response to SARS-CoV-2 infection: “In multivariable analyses, we observed sex-specific patterns of autoreactivity associated with the presence or absence (as well as timing and clustering of symptoms) associated with prior COVID-19 illness. Whereas the overall AAB response was more prominent in women following asymptomatic infection, the breadth and extent of AAB reactivity was more prominent in men following at least mildly symptomatic infection. Notably, the observed reactivity included distinct antigens with molecular homology with SARS-CoV-2.”
Medication safety group issues alert on COVID-19 antiviral: “The Institute for Safe Medication Practices on Jan. 3 issued an alert warning pharmacists of potential error risks with Paxlovid, Pfizer's COVID-19 antiviral pill regimen.
The alert states patients with severe renal impairment should not receive the drug, and patients with moderate renal impairment should receive a dose reduction. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken twice daily for no more than five consecutive days…
ISMP said additional potential safety issues include patients accidentally failing to take both tablets together and drug interactions.”
About health insurance
CMS wants insurers to offer standardized plan options on the ACA exchanges: The proposed ACA rules reported yesterday have a provision for standardizing offerings. Medicare supplements have had this feature for many years and it makes comparisons among plans much easier.
ACO Investment Model Produced Savings, But The Majority Of Participants Exited When Faced With Downside Risk: “Medicare’s Accountable Care Organization (ACO) Investment Model (AIM) provided up-front funding to forty-one small, rurally located ACOs to encourage their participation in the Medicare Shared Savings Program. We estimate net savings to Medicare of $381.5 million over three years, driven by utilization reductions in inpatient and other institutional care and by the absence of shared risk for potential increases in Medicare spending incurred by participants. These savings suggest that population-based payment models can enable providers to better meet the needs of rural populations through greater flexibility in care delivery. However, nearly two-thirds of AIM ACOs exited the Medicare Shared Savings Program when faced with the requirement to assume downside financial risk, starting in year four of participation.”
About healthcare technology
Jury finds Theranos founder Elizabeth Holmes guilty of fraud: “After seven days of deliberations, a federal jury found Holmes, 37, guilty of defrauding investors while raising money for Theranos. Holmes was convicted of conspiracy to defraud investors and three counts of wire fraud. The jury found her not guilty of conspiring to defraud patients and cleared her on two individual patient-related charges and one count of lying in paid advertisements. The jury couldn’t reach a unanimous verdict on three counts of defrauding individual investors, possibly leaving the door open for a retrial on those specific charges.”
No word yet about appeals or the government going to trial again on the undecided counts.
About healthcare IT
Differences in estimates for 10-year risk of cardiovascular disease in Black versus White individuals with identical risk factor profiles using pooled cohort equations: an in silico cohort study: Another example of an algorithm that produces inaccurate results because of faulty race data. [Emphasis added below].
“Sex-specific and race-specific pooled cohort equations (PCEs) are recommended for estimating the 10-year risk of cardiovascular disease, with an absolute risk of more than 7·5% indicating a clinical decision threshold. We compared differences between Black and White individuals in PCE-estimated absolute cardiovascular disease risk across various plausible risk factor combinations with the aim of evaluating if using the PCE might result in different clinical decisions in Black versus White individuals with identical risk profiles….
There are several clinical implications of our findings. First, the use of PCE could result in Black individuals with select risk factor combinations becoming more eligible for receiving statin treatment than their White counterparts with identical risk profiles. Although the direction of this potential bias might seem somewhat reassuring (relative to the opposite scenario of Black individuals not receiving statins relative to their White counterparts), the risks associated with over-treatment—ie, financial, psychological, side-effects, and quality of life—are not trivial.”
About pharma
2021 drug approvals: In a year dominated by COVID, biopharma managed to deliver 55 new drugs: “All told, the industry nabbed 55 FDA approvals in 2021. They include the controversial accelerated approval for Biogen's Alzheimer's drug Aduhelm, Pfizer's record-shattering COVID-19 vaccine, Comirnaty, and many others.
Not all 2021 approvals commanded as many headlines as Aduhelm and Comirnaty. Aside from those notable companies, also represented in 2021's crop of new approvals were Amgen, Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Regeneron.”
The article has details on each drug.
List prices for 460 drugs increased Jan. 1: “Drugmakers on Jan. 1 increased the list price of 460 medications by a median of 4.9 percent, according to data from 46brooklyn, a nonprofit drug research firm.
The price hikes are comparable to those seen at the start of previous years. On Jan. 1, 2021, drugmakers increased the price of 629 drugs.”