Today is International Women’s Day
About Covid-19
How One Firm Put an ‘Extraordinary Burden’ on the U.S.’s Troubled Stockpile: This article from The NY Times is a must read. I would not be surprised if it won a Pulitzer. It is about how influence peddling by a biotech firm has taken needed funding from our country’s COVID-19 response.
When You’ve Been Fully Vaccinated: Latest CDC update.
”What’s Changed:
If you’ve been fully vaccinated:
You can gather indoors with fully vaccinated people without wearing a mask.
You can gather indoors with unvaccinated people from one other household (for example, visiting with relatives who all live together) without masks, unless any of those people or anyone they live with has an increased risk for severe illness from COVID-19.
If you’ve been around someone who has COVID-19, you do not need to stay away from others or get tested unless you have symptoms.
However, if you live in a group setting (like a correctional or detention facility or group home) and are around someone who has COVID-19, you should still stay away from others for 14 days and get tested, even if you don’t have symptoms.”
U.S. Government Scientists Skeptical of One-Shot Regimen for Pfizer, Moderna Covid Vaccines: “U.S. government scientists are pushing back against calls for one-dose regimens for two Covid-19 vaccines designed to be administered with two shots, saying there isn’t enough evidence that a single dose provides long-term protection.
’It is essential that these vaccines be used as authorized by FDA in order to prevent Covid-19 and related hospitalizations and death,’ Peter Marks, director of the Food and Drug Administration’s center that oversees vaccines, told The Wall Street Journal.”
US could reach herd immunity by summer through vaccinations alone, CNN analysis finds: “At the current pace of about 2 million shots per day -- the latest seven-day average of doses administered reported by the US Centers for Disease Control and Prevention -- the US could reach herd immunity by summer through vaccinations alone. It will likely be even sooner, if factoring in individuals who may have some natural immunity due to prior infection.”
Early data suggest AstraZeneca's COVID-19 vaccine effective against Brazil variant: report: “According to a source familiar with the matter, preliminary study findings indicate that AstraZeneca's coronavirus vaccine AZD1222 is effective against the P.1 variant of SARS-CoV-2 first identified in Brazil. The source did not provide exact efficacy of the vaccine against the P.1 strain, but said full results from the study should be released soon, possibly this month.”
Merck has better luck with 2nd COVID-19 drug attempt as it sees a positive in early molnupiravir data: “Over the weekend, the Big Pharma and its biotech partner Ridgeback announced their drug, molnupiravir, hit one of its secondary objectives from a new trial, namely to reduce time to negativity of infectious SARS-CoV-2 virus isolation from swabs in patients with symptomatic COVID-19.
The data show that, at Day 5, there was a reduction in positive viral culture in subjects who received molnupiravir (all doses) compared to placebo: 0% (0/47) for molnupiravir and 24% (6/25) for placebo.”
Biden team plots the country’s first national Covid testing strategy: “The Biden administration is preparing to launch the first of several Covid-19 testing hubs to coordinate and oversee a $650 million expansion of testing in K-8 schools and congregate settings like homeless shelters.
The Department of Health and Human Services hopes to open the first hub in April, as part of a public-private partnership that could eventually add up to 25 million tests per month to the nation’s testing totals, two sources briefed on the plans told POLITICO.”
Fever-scanner company pulls device off market following FDA warning: “The company, Certify Global, was among seven manufacturers whose products were tested in research first reported Thursday by The Washington Post. The research found critical flaws in thermal-imaging systems’ ability to accurately detect people’s skin temperature. Companies have advertised the systems as a powerful first line of defense in screening people for covid infections.”
Oxford Immunotec’s COVID-19 T Cell Test Gets European Clearance: “Oxford Immunotec has obtained CE Mark certification for its T-SPOT.COVID test, a diagnostic that detects T cell immune responses to SARS-CoV-2 using blood samples.
Antibodies are not always produced in response to SARS-CoV-2 infection, or they may wane quickly after infection. ‘In the absence of an antibody response, the T cell response may be protective from SARS-CoV-2 infection,’ the company said.
According to a study that evaluated samples collected in the U.S., the test showed it could detect a SARS-CoV-2 T cell mediated immune response in patients who tested positive for coronavirus, even when they had negative serology test results for antibodies. The company has filed for an Emergency Use Authorization (EUA) from the FDA for its test.”
Cue Health's COVID-19 cartridge test authorized for home use with no prescription: “One year into the pandemic, the FDA has authorized its first molecular COVID-19 diagnostic that can be performed completely at home and purchased without a prescription.
Cue Health’s cartridge-based nasal swab test can be used solo or for children as young as two with adult supervision, regardless of whether a person is showing symptoms or suspects that they’ve been exposed directly to the coronavirus.”
The article has a photo of the device.
Abbott Secures EUA for COVID-19 Combination Test: “Abbott has received Emergency Use Authorization (EUA) from the FDA for its Alinity m Resp-4-Plex molecular assay, a combination test for SARS-CoV-2, Influenza A and B, and respiratory syncytial virus (RSV).
The test uses either an anterior nasal or nasopharyngeal swab collected by a healthcare provider or an anterior nasal swab self-collected at a healthcare location for patients suspected of COVID-19 infection.”
How the pandemic could change architecture: The headline speaks for itself. It is very readable, graphically displayed description of the changes. One prediction: We will walk in the street and eat on the sidewalk.
Covid-19 Pill Shows Promise in Preliminary Testing: “The pill, which is being developed by Ridgeback Biotherapeutics LP and Merck & Co., significantly reduced infectious virus in subjects in a mid-stage study after five days of treatment, Ridgeback is reporting at a virtual meeting of infectious-disease scientists Saturday…
Tests didn’t detect infectious virus in any of the study volunteers who took molnupiravir twice a day after five days of treatment, while 24% of subjects who received a placebo did, Ridgeback reported at the virtual Conference on Retroviruses and Opportunistic Infections.”
Oxford-AstraZeneca Covid-19 Vaccine Startup in Conflict With University Ahead of Planned IPO: “Nine-hundred-year-old Oxford is wrestling with how to rewrite its rules for fostering companies created by its academics or born in its labs, while in a standoff with one that has been thrust into the spotlight by the pandemic. The startup, Vaccitech Ltd., has been pitching to potential investors and laying groundwork for a stock listing in New York as early as this year, according to people close to the plans and marketing documents reviewed by The Wall Street Journal.
Investors are aiming for an IPO valuation of around $700 million, with expectations that Vaccitech could be a $1 billion company by year-end.”
States propose bills to ban employers from mandating coronavirus vaccines: A really good discussion of the issue of employer vaccine mandates.
Scroll down this article for a concise breakdown of what’s in the $1.9 Trillion Senate bill that passed this weekend and which the House is expected to pass today or tomorrow.
About pharma
GlaxoSmithKline's doctor payments double as relaxed policy plays out: “GlaxoSmithKline payments to doctors are on the rise again, as its relaxed payment policy continues. It notched a 40% increase from $11 million in 2017 to more than $15 million in 2019 in the U.S., likely reflecting its loosening of a formerly strict physician payment policy.
The company's 2016 policy, decreed by former CEO Andrew Witty, banned direct payments to doctors speaking on behalf of the pharma and contributed to a hefty drop in payouts from $30.6 million in 2016 to $11 million the following year, according to data from the U.S. Open Payments database. GSK’s tally dropped even further in 2018 to $8.9 million before increasing in 2019.
That spending is now on the rise around the world. GSK spent £19.3 million on payments to physicians in 2019, almost double the £9.9 million it paid out in 2017, which was the year Emma Walmsley took over as CEO…”
Novartis' £1.79M gene therapy Zolgensma scores cost watchdog's backing, threatening Biogen's Spinraza: The battle continues in the super-expensive category: “NICE endorsed Zolgensma, which costs £1.79 million per dose, for babies aged up to 12 months with type 1 spinal muscular atrophy (SMA). If the draft guidance is finalized, the med would become the most expensive drug ever to be approved by the cost-effectiveness agency.” In a related article, see: 10 most expensive drugs in the US
Amgen to Buy Five Prime Therapeutics for $1.9 Billion: “Amgen has agreed to acquire Five Prime Therapeutics, a South San Francisco biotech company, for $1.9 billion, a deal that will net the biopharma titan a pipeline that includes a promising investigational gastric cancer drug.
As part of the acquisition, Amgen will obtain bemarituzumab, an anti-FGFR2b antibody that is ready to enter phase 3 clinical trials. The drug holds promise in treating gastric cancer and its phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer demonstrated positive results.”
In Head-to-Head Study, Eli Lilly’s Diabetes Drug Candidate Surpasses Ozempic: “Eli Lilly said its investigational drug, tirzepatide, reduced blood sugar and body weight in adults with type 2 diabetes significantly more than Novo Nordisk’s blockbuster Ozempic (semaglutide), in a head-to-head clinical study.”
About hospitals and health systems
Trinity Health reports $2.7B net income over 6 months: “Trinity posted revenue of $10.3 billion in the six months ended Dec. 31, up 5.9 percent from $9.7 billion in the same period of 2019. The health system attributed the increase to $534.2 million in provider relief grants recognized. Excluding those grants, revenue increased less than 1 percent year over year, the health system said.”
Hospitals will likely continue to have staffing shortages despite falling COVID-19 cases: “Despite recent declines in coronavirus cases nationwide, many hospitals may still have workforce shortages over the next 30 days due to COVID-19 hospitalizations, according to estimates from George Washington University.
The university's Fitzhugh Mullan Institute for Health Workforce Equity recently launched its COVID-19 County Workforce Estimator, which predicts that between now and March 20, 7% of U.S. counties will experience ‘significant strains’ on their hospital workforces. It attributes the strain to long-standing staffing problems with the added pressure of the pandemic.
It also predicts that 209 counties will need to implement crisis workforce strategies due to its analysis that ICU doctors in those counties will be forced to take care of 24 or more patients at a time.”
Ascension Ventures Finalizes Fifth Strategic Healthcare Venture Fund; Expands Assets Under Management to More Than $1 Billion: “Ascension Ventures (AV) today announced the closing of a $285 million strategic venture capital fund. This fifth fund brings the firm’s total assets under management to more than $1 billion. The new fund is backed by 13 leading health system partners directly involved in AV’s diligence and investment approval process…
Joining Ascension as limited partners in the new fund are continuing health system partners AdventHealth, Carle Foundation, CentraCare, Children’s Medical Center of Dallas, Intermountain Healthcare, Novant Health, OhioHealth and OSF HealthCare. New limited partners in the fund include Luminis Health, Sentara Healthcare, Texas Health Resources and one other undisclosed health system.”
About healthcare IT
65,000 Humana members' information exposed in wrongful records access incidents: The headline speaks for itself.
About the public’s health
Associations of Fish Consumption With Risk of Cardiovascular Disease and Mortality Among Individuals With or Without Vascular Disease From 58 Countries: “Findings of this pooled analysis of 4 cohort studies indicated that a minimal fish intake of 175 g (approximately 2 servings) weekly is associated with lower risk of major CVD and mortality among patients with prior CVD but not in general populations. The consumption of fish (especially oily fish) should be evaluated in randomized trials of clinical outcomes among people with vascular disease.”
Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial: “Short-course antibiotic therapy appeared to be comparable to standard care for the treatment of previously healthy children with CAP not requiring hospitalization. Clinical practice guidelines should consider recommending 5 days of amoxicillin for pediatric pneumonia management in accordance with antimicrobial stewardship principles.”