Policy Updates 11/4/2022

  1. COVID

CNN: Pfizer/BioNTech Say Updated Covid-19 Booster Generates 'Substantially Higher' Protection Against Omicron Subvariants Than Original Vaccine
Pfizer and BioNTech said Friday that the immune responses against Omicron BA.4/BA.5 subvariants were “substantially higher” in people who got its new bivalent booster compared with people who received the companies’ original Covid-19 vaccine. (Christensen, 11/4)

Los Angeles Daily News: COVID-19 Hospitalizations Rise Again In LA County
The number of COVID-19-positive patients in Los Angeles County hospitals rose again on Wednesday, Nov. 2, with state figures showing the figure again rising above 400. (11/2)

Scientific American: New Omicron Variants Are Here--What We Know So Far
There is no question these variants are increasing at a rapid rate. BQ.1.1, for example, currently accounts for 7,000 cases per day and appears to be doubling every nine days, says Trevor Bedford, a virologist at the Fred Hutchinson Cancer Center who models COVID evolution. It is outpacing BA.5—the current leading variant in the U.S. That’s because every person sick with BQ.1.1 is infecting an average of 1.4 other people, while those sick with BA.5 are averaging an infection of less than one other person. (11/1)

CIDRAP: Severe Adverse Events More Likely In Previously Infected COVID Vaccinees
Americans who received an mRNA COVID-19 vaccine after SARS-CoV-2 infection are more likely to experience severe systemic adverse events (AEs) than their never-infected counterparts, according to a study published yesterday in Vaccine. (11/2)

  1. Opioids

NPR: CDC Issues New Opioid Prescribing Guidance, Giving Doctors More Leeway To Treat Pain
The Centers for Disease Control and Prevention has issued new guidance for clinicians on how and when to prescribe opioids for pain. Released Thursday, this revamps the agency's 2016 recommendations which some doctors and patients have criticized for promoting a culture of austerity around opioids. (Stone and Huang, 11/3)

  1. Children’s Health

CNN: Treatment Approved In Europe To Prevent RSV In Infants Could Be Coming To The US Soon
A preventive treatment for lower respiratory tract infections caused by RSV got the go ahead from the European Commission on Friday, according to one of the companies that make it. The treatment is the first of its kind to protect all infants in their first year of life. (Christensen, 11/4)

Stat: Weight-Loss Drug Had Dramatic Effect In Adolescents With Obesity
A blockbuster weight-loss medicine led to dramatic effects for adolescents diagnosed with obesity, a result that will likely widen the use of an in-demand drug — and fan a debate over whether someone’s body weight should be treated as a disease. (Garde, 11/2)

The Washington Post: High Demand For Amoxicillin Is Causing Shortages Amid Child RSV Surge
As respiratory illnesses spread rapidly among children across the country, an increased demand for amoxicillin is causing a shortage of the commonly prescribed antibiotic. Parents filling their kids’ prescriptions may have to try a few pharmacies or end up with a different strength or form than originally prescribed, but amoxicillin in some form is generally still available, pharmacists said. The supply of the liquid version is most strained, along with some chewable tablets. (McDaniel, 11/2)

The New York Times: US Children’s Hospitals Are Overwhelmed By RSV
“Every children’s hospital that I’m aware of is absolutely swamped,” said Dr. Coleen Cunningham, the pediatrician in chief at Children’s Hospital of Orange County, a 334-bed facility in Southern California that is so full that children are being treated right in the emergency room as they wait for inpatient beds — sometimes for more than 24 hours. (Baumgaertner, 11/1)

NBC News: CDC Warns Of Bacteria In Dental Waterlines After Disease Outbreaks In Children
The Centers for Disease Control and Prevention on Monday issued a health advisory about waterborne bacteria in dental plumbing systems after children who visited pediatric dental clinics were infected with nontuberculous Mycobacteria. (Alsharif, 11/1)

The Atlantic: The Worst Pediatric-Care Crisis In Decades
At Johns Hopkins Children’s Center, in Maryland, staff has pitched a tent outside the emergency department to accommodate overflow; Connecticut Children’s Hospital mulled calling in the National Guard. It’s already the largest surge of infectious illnesses that some pediatricians have seen in their decades-long careers, and many worry that the worst is yet to come. (Wu, 10/31)

The New York Times: Scientists Are Gaining On RSV, A Persistent Threat To Children
Of the three respiratory viruses Americans are grappling with this winter, two — the coronavirus and the flu — are well-known threats. The third, respiratory syncytial virus, which already has sent thousands of children to hospitals, is a mystery to many. “It is, unfortunately, one of those large killers that nobody knows about,” said Dr. Keith Klugman, who directs the pneumonia program at the Bill & Melinda Gates Foundation. (Mandavilli, 11/1)

Stat: Polio-Like Syndrome In Kids Seems Not To Flare, Adding To Mystery
Physicians who treat children with acute flaccid myelitis, or AFM, had been steeling themselves this fall for an onslaught of cases. (Branswell, 10/31)

CNN: Drinking Caffeine While Pregnant Impacts Child's Height: Study
Starting the day with a hot cup of caffeinated coffee or tea may sound divine to some, but it could have negative impacts for the children of people who are pregnant, according to a new study. Children who were exposed to small amounts of caffeine before birth were found on average to be shorter than the children of people who did not consume caffeine while pregnant, according to the study published Monday in JAMA Network Open. (Holcombe, 10/31)

The Washington Post: Many Lockdown Babies Slower At Social Development, Faster At Crawling, Study Says
Early in the pandemic, when much of the world was in lockdown, many parents and other caregivers expressed fears about how a historic period of prolonged isolation could affect their children. Now, a study out of Ireland has shed some light on this question. Its results suggest that babies born during Ireland’s first covid-19 lockdown were likely to be slower to develop some social communication skills than their pre-pandemic peers. They were less likely to be able to wave goodbye, point at things and know one “definite and meaningful word” by the time they turn 1. On the other hand, they were more likely to be able to crawl. (Timsit, 10/28)

AP: Massive Learning Setbacks Show COVID's Sweeping Toll On Kids
The COVID-19 pandemic devastated poor children’s well-being, not just by closing their schools, but also by taking away their parents’ jobs, sickening their families and teachers, and adding chaos and fear to their daily lives. The scale of the disruption to American kids’ education is evident in a district-by-district analysis of test scores shared exclusively with The Associated Press. The data provide the most comprehensive look yet at how much schoolchildren have fallen behind academically. (Toness and Lurye, 10/28)

  1. Gender Issues

Los Angeles Times: New L.A. County Buildings Must Have All-Gender Restrooms
Los Angeles County supervisors voted Tuesday to require county facilities to provide single-occupant, all-gender bathrooms. The policy requires that the bathrooms be included in all newly constructed, renovated or leased L.A. County buildings. (Martinez, 11/2)

Modern Healthcare: Providers Cut Gender-Affirming Care Amid Political, Violent Threats
Clinics that specialize in gender-affirming services have historically been the main sources of support for LGBTQ patients amid shifting laws and public opinion. As demand for LGBTQ-inclusive health services has increased in recent years, major institutions have expanded the care they provide to this population. (Hartnett and Devereaux, 10/28)

  1. Mental Health

AP: Psychedelic 'Magic Mushroom' Drug May Ease Some Depression
The psychedelic chemical in “magic mushrooms” may ease depression in some hard-to-treat patients, a preliminary study found. The effects were modest and waned over time but they occurred with a single experimental dose in people who previously had gotten little relief from standard antidepressants. (Tanner, 11/2)

Bloomberg Law: California Providers Can’t Keep Up With Mental Health Parity Law
California health insurers are having trouble complying with a new state law intended to protect people from paying high out-of-pocket expenses for psychological or addiction care. The law (S.B. 855) requires every health plan that provides hospital, medical, or surgical coverage to also cover mental health and substance-use disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, a handbook used by health-care professionals. (11/2)

  1. Monkeypox

Reuters: 'Considerable' Monkeypox Transmission Happens Before Symptoms, Study Suggests
Monkeypox can spread before symptoms appear, British researchers said on Wednesday, providing the first evidence indicating the virus can be transmitted this way. It was previously thought that monkeypox was almost entirely spread by people who were already sick, although pre-symptomatic transmission had not been ruled out and some routine screening had picked up cases without symptoms. (Rigby, 11/3)

CIDRAP: Meta-Analysis Suggests 14% Hospitalization Rate For Monkeypox Patients
A new study published in eClinicalMedicine analyzed 19 studies on monkeypox, which included 7,553 reported cases, among which there were 555 hospitalizations. The meta-analysis suggests monkeypox patients have a 14.1% hospitalization rate. (11/2)

  1. Flu

CalMatters: California Flu, COVID, RSV: State Faces Triple Threat
Forget “twindemic” — California may be in for a three-headed Cerberus of respiratory illnesses this winter as the flu, respiratory syncytial virus and COVID-19 collide. (Hoeven, 11/2)

  1. Medical Devices

CNN: FDA Panel Examines Evidence That Pulse Oximeters May Not Work As Well On Dark Skin
A panel of the US Food and Drug Administration’s Medical Devices Advisory Committee met Tuesday to review clinical data about the accuracy of pulse oximetry in patients with darker skin and to discuss recommendations on using these devices on people with dark skin tones and whether they should have labels – such as a black box warning – noting that inaccurate readings may be associated with skin color. (Howard, 11/1)

Becker's Hospital Review: FDA Warns Of Tracheostomy Tube Shortage
There is a national shortage of tracheostomy tubes ... and the dearth is more likely to affect pediatric patients because there are few alternative products, the FDA said Oct. 31. ... The FDA tapped HHS' Administration for Strategic Preparedness and Response to help manufacturers secure more raw materials and boost the product's supply. (Twenter, 11/1)

Stat: Why Inaccuracies With Pulse Oximeters Were Ignored For So Long
A Food and Drug Administration advisory committee Tuesday will take up the issue of whether pulse oximeters, the ubiquitous medical devices that became a mainstay for assessing patient oxygen levels during the Covid-19 pandemic, need to be regulated differently — or even completely reconceived — based on research showing the devices are less accurate in people with darker skin. (McFarling, 11/1)

  1. Women’s Health

Axios: Experts: Anesthesia Use Disparities Could Negatively Impact Black Maternal Health
New research showing racial disparities in regional anesthesia use has major implications for Black women — especially in pregnancy and childbirth, medical experts and reproductive health advocates tell Axios. (Chen, 11/1)

KHN: ‘Fourth Trimester’ Focus Is Pushed To Prevent Maternal Deaths
For several weeks a year, the work of nurse-midwife Karen Sheffield-Abdullah is really detective work. She and a team of other medical investigators with the North Carolina public health department scour the hospital records and coroner reports of new moms who died after giving birth. These maternal mortality review committees look for clues about what contributed to the deaths — unfilled prescriptions, missed postnatal appointments, signs of trouble that doctors overlooked — to figure out how many of them could have been prevented. (Dembosky, 10/31)

  1. Daylight Savings Time

The Washington Post: Why Daylight Saving Time Is Worse For Your Body Than Standard Time
Within days, 48 states and the District of Columbia will reset their clocks and fall back into standard time. From a health standpoint, most sleep and circadian experts say we should stay there. Experts say early-morning sunlight is key to maintaining our circadian rhythms, sleep-wake cycles and overall health. Phyllis Zee, a neurologist and chief of sleep medicine at Northwestern University Feinberg School of Medicine, said without that sunlight, we can slip into circadian misalignment — “when your internal body clocks fall out of sync with that of the sun clock and your social clocks.” (Steckelberg and Bever, 11/2)

  1. Persons with Disabilities

Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification

Willyanne DeCormier Plosky et al.


Willi Horner-Johnson et al.