About Covid-19
FDA authorizes Pfizer-BioNTech vaccine for children 5 to 11: “The Food and Drug Administration’s emergency clearance is for a two-shot regimen administered three weeks apart. The dose, 10 micrograms, is one-third that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91 percent effective at preventing covid-19, the illness caused by the virus. The vaccine’s safety was studied in about 3,100 children who received the shot and had no serious side effects, the agency said.”
Community transmission and viral load kinetics of the SARS-CoV-2 delta (B.1.617.2) variant in vaccinated and unvaccinated individuals in the UK: a prospective, longitudinal, cohort study: “Vaccination reduces the risk of delta variant infection and accelerates viral clearance. Nonetheless, fully vaccinated individuals with breakthrough infections have peak viral load similar to unvaccinated cases and can efficiently transmit infection in household settings, including to fully vaccinated contacts. Host–virus interactions early in infection may shape the entire viral trajectory.”
Supreme Court upholds vaccine mandate for Maine health-care workers that does not include religious exemption: “The Supreme Court Friday turned down a request from a group of Maine health-care workers to block a state coronavirus vaccination mandate that does not contain an exception for religious objectors.
Three conservative justices dissented from the decision. While the majority did not give a reason for denying the request, Justice Neil M. Gorsuch wrote that the workers deserved an exemption.”
Federal rule in the works could force unvaccinated workers to pay for their COVID-19 tests: “A federal vaccination mandate currently under review for private companies could allow employers to make workers who refuse to get the shot pay for required COVID-19 testing and masks.”
About pharma
J&J to Pay $297 Million to Settle Texas Opioid Lawsuits: “Johnson & Johnson (J&J) has agreed to pay $297 million to Texas by year’s end to settle claims over the company’s alleged role in the state’s opioid epidemic if enough local governments approve the settlement.
The proposed deal is independent from a proposed $26 billion national opioid settlement negotiated with the three largest U.S. drug distributors — McKesson, Cardinal Health and AmerisourceBergen — and drugmaker J&J, who agreed to pay $5 billion over nine years under its terms.”
Why do placebos work? Scientists identify key brain pathway: The study used functional MRI readings:
”Both the placebo and nocebo[when patients are told a placebo has harmful side effects] influenced activity in the brainstem, the researchers report this week in The Journal of Neuroscience. The placebo effect increased activity in an area called the rostral ventromedial medulla, which relays pain information, and decreased activity in the periaqueductal gray, which helps the body suppress pain. The nocebo effect induced the opposite change. (The findings may seem counterintuitive, but multiple areas of the brainstem act in complex ways when it comes to creating the sensation of pain, the authors say.)”
About healthcare IT
FDA releases ‘guiding principles’ for AI/ML device development: “The FDA, along with its U.K. and Canadian counterparts, said the principles are intended to lay the foundation for Good Machine Learning Practice…
The principles are:
The total product life cycle uses multidisciplinary expertise.
The model design is implemented with good software engineering and security practices.
Participants and data sets represent the intended patient population.
Training data sets are independent of test sets.
Selected reference data sets are based upon best available methods.
Model design is tailored to the available data and reflects intended device use.
Focus is placed on the performance of the human-AI team.
Testing demonstrates device performance during clinically relevant conditions.
Users are provided clear, essential information.
Deployed models are monitored for performance, and retraining risks are managed.”
Hacker breached Massachusetts systems' emails for 6+ months; 200,000+ individuals affected: “Worcester-based UMass Memorial Health began notifying more than 200,000 patients and health plan participants that a hacker breached employee email accounts containing their personal information, according to data the health system shared with HHS…”
About the public’s health
US lowers cutoff for lead poisoning in young kids: “The more stringent standard announced Thursday by the Centers for Disease Control and Prevention means the number of children ages 1 to 5 considered to have high blood lead levels will grow from about 200,000 to about 500,000.
Some experts think the change was overdue. The CDC last changed the definition nine years ago and pledged to consider an update every four years. But work on a revision hit obstacles during the Trump administration, said Patrick Breysse, who heads the CDC’s National Center for Environmental Health.”
No chocolate or ice cream ads for kids as Spain tackles obesity: A lesson for the US?
”Spain will ban advertising of unhealthy foods and drinks like chocolate, biscuits and ice cream aimed at children to help fight obesity in young people, the consumer affairs minister said on Thursday.”
About health insurance
Molina sees 22% dip in net income despite revenue growth in Q3: “Molina Healthcare's total revenue was up over $2 billion from 2020's third quarter, currently sitting at $7 billion.
However, profits were down this quarter, with the insurer reporting a net income of $143 million. This is a 22 percent decrease from 2020's $185 million in profits during the same quarter.”
Most insurers have remained profitable this year due to a reduction in elective procedures.
The More Things Change, the More They Stay the Same: An Analysis of the Generosity of Employment-Based Health Insurance, 2013–2019: From EBRI: “In this paper we explore trends in actuarial value — or relative generosity of health plans — in the employment-based health coverage market since the implementation of the major coverage provisions of the Affordable Care Act (ACA) in 2014. Because there is a concern that workers would migrate to lower actuarial value (AV) plans in the exchanges if the Biden Health Care Plan were adopted, it is also important to know whether workers are already enrolling in lower AV plans in the employment-based market as a result of the ACA. In our analysis, we observe:
Both average and median AV were about 83 percent in each year from 2013 to 2019.
There were differences in average AV by plan type. The average AV for enrollees in health maintenance organizations (HMOs)/exclusive provider organizations (EPOs) was highest. This was followed by the AV of enrollees in fee-for-service plans. Preferred provider organization (PPO) and point of service (POS) enrollees saw an average AV of 85 percent and 84 percent, respectively. Not surprisingly, plans linked to spending accounts had the lowest AVs.
Average AV increased for every type of health plan between 2013 and 2019.
We did not find that demographics significantly affected plan choice.
We did find variation in AV by industry. Workers in retail trade, agriculture, forestry, fishing, construction, finance, insurance, and real estate are in the lowest AV plans.
As opposed to group coverage, health insurance purchased in the individual market tends to be somewhat less generous in benefits, on average.”
In other words, employer-sponsored health insurance has remained as generous as it was when the ACA was implemented.
About healthcare regulations
HHS Moves to Undo Trump’s Retrospective Review of Agency Rules: “The Health and Human Services Department on Thursday moved to withdraw or repeal a last-minute Trump administration rule that would have caused health regulations to expire if they weren’t reviewed every 10 years.
The HHS released a proposal that would do away with the rule, (RIN 0991-AC24), which was published in the Federal Register on Jan. 19, one day before President Joe Bidentook office. Under the rule, the HHS would have had five years to assess regulations that are more than 10 years old, and the department could have extended that deadline one time per regulation, for up to a year.
The final rule exempted certain Food and Drug Administration regulations and annual Affordable Care Act rules, in addition to procedural rules, regulations issued jointly with other agencies, and regulations around internal management.”