First Edition: November 22, 2021

KHN: Why You Can’t Find Cheap At-Home Covid Tests
While developing a rapid test that detects the coronavirus in someone’s saliva, Blink Science, a Florida-based startup, heard something startling: The Food and Drug Administration had more than 3,000 emergency use authorization applications and didn’t have the resources to get through them. “We want to try to avoid the EUA quagmire,” said Peb Hendrix, the startup’s vice president of operations. Its test is still in early development. On the advice of consultants, the company is weighing an alternative route through the FDA to the U.S. market. (Pradhan and Norman, 11/22)

KHN: Lifting DC’s Strict Indoor Mask Mandate Triggers Mix Of Confusion, Anxiety And Relief
A mile northeast of Capitol Hill in Washington, D.C., along what’s known as the H Street corridor, about half the people crowding the sidewalks are wearing masks. Perhaps it’s because they know that when they step into any business or establishment here, they will have to put one on anyway. The capital, after all, is one of the few remaining cities or states nationwide that mandate masks for public indoor spaces — at least it has, until today. “We have a bunch of rule followers,” said Claire Bengur, the owner of Atlas Salon, which has been in the neighborhood since 2018. “I am so thankful that my salon is in D.C.” She’s been glad to have a mask requirement, she said, because it’s impossible to do clients’ hair without standing close to them. (Michelle Gomez, 11/22)

KHN: ‘An Arm And A Leg’: The Insurance Warrior’s Battle Plan
Matthew Lientz was an engineer for Boeing for over 30 years. When he was diagnosed with a rare form of cancer, he needed surgery from an expert doctor in another state. Although the surgery was his only option, his insurance denied the claim. That’s when his wife, Diane, contacted Laurie Todd, who calls herself the “Insurance Warrior.” Together, the three of them made the case for Lientz’s life. Fourteen years later, the speeches they gave in a conference room full of executives are a master class in winning insurance appeals — and living to tell the tale. Through this battle, Todd learned that taking on your health insurance provider often means going up against your employer. That’s because most large companies “self-insure.” (Weissmann, 11/22)

KHN: Success Of Covid Antiviral Pills Hinges On Access To Speedy And Accurate Tests
Within a few weeks, perhaps before many Americans finish decorating for the holidays, the U.S. could have access to a new antiviral pill from Merck expected to alter the deadly trajectory of the covid-19 pandemic — with a second option from Pfizer to follow shortly after. Now under federal review, both pills are being hailed by infectious-disease doctors not prone to superlatives. “This is truly a game changer,” said Dr. Daniel Griffin, an expert on infectious diseases and immunology at Columbia University. “This is up there with vaccines. It’s not a substitute for vaccines; we still want to get people vaccinated. But, boy, this is just another great tool to have.” (Aleccia, 11/22)

KHN: Journalists Cover Issues From Pollution To Vaccines And The Spread Of Covid In Hospitals
KHN and California Healthline staff made the rounds on national and local media this week to discuss their stories. Here’s a collection of their appearances.

The New York Times: C.D.C. Endorses Covid Vaccine Booster Shots For All Adults
The recommendation fulfills President Biden’s pledge in August to make the extra doses available to all adults, and caps months of scientific debate over whether most people really needed boosters. The shots are already available at many drugstores, doctors’ offices and vaccination centers. The C.D.C. said that Americans over age 50, as well as those 18 and older living in long-term care facilities, “should” get booster shots of the Pfizer-BioNTech or Moderna vaccines. All other adults over age 18 “may” get booster doses, the agency decided. Recipients of Johnson & Johnson’s one-dose vaccine already were cleared to get a booster at least two months after the initial shot. (Mandavilli, 11/19)

The Washington Post: With Federal Sign-Offs, All American Adults Now Eligible For Coronavirus Vaccine Boosters
Federal health officials hope a straightforward boosters-for-all policy will prompt millions more people to get the shots before they travel or gather with friends and family over the holidays. Many are concerned about the worsening picture as winter approaches. After new cases dipped to almost 69,000 on Oct. 25 — their lowest point in months — they began climbing again, with the seven-day average rising 40 percent to more than 96,000 on Thursday. The final piece of the booster-policy overhaul fell into place early Friday evening when Rochelle Walensky, director of the Centers for Disease Control and Prevention, accepted two unanimous recommendations from the agency’s independent experts. The Advisory Committee on Immunization Practices said anyone 18 and older may get a booster and — to stress the urgency of increasing protection for the most vulnerable age group — anyone 50 and older should make sure they get one. (Sun, McGinley and Stead Sellers, 11/19)

Bloomberg: Pfizer’s Covid Shot Is Approved for Young Children In Canada
Canadian health authorities authorized Pfizer Inc.’s Covid-19 shot for children age 5 to 11, opening the door for a new phase of the country’s vaccination drive. Health Canada on Friday announced it has approved a lower dose of Pfizer Inc. and BioNTech SE‘s Covid-19 vaccine for all school-age children. “After a thorough and independent scientific review of the evidence, the department has determined that the benefits of this vaccine for children between 5 and 11 years of age outweigh the risks,” according to a statement. (Argitis, 11/19)

Reuters: Activists Urge Biden To Push For Intellectual Property Waiver For COVID-19 Vaccines
Fifteen human rights groups are urging U.S. President Joe Biden to get personally engaged in a long-running fight to enact an intellectual property waiver for COVID-19 vaccines at the World Trade Organization, calling his leadership "a moral necessity. " Amnesty International, Human Rights Watch, Oxfam, Public Citizen and 11 other groups told Biden in a letter that an emergency waiver was urgently needed to combat the pandemic, noting that fewer than 7% of people in low-income countries had received a first COVID-19 vaccine and vaccines remained scarce. (Shalal, 11/22)

AP: GOP Embraces Natural Immunity As Substitute For Vaccines
Republicans fighting President Joe Biden’s coronavirus vaccine mandates are wielding a new weapon against the White House rules: natural immunity. They contend that people who have recovered from the virus have enough immunity and antibodies to not need COVID-19 vaccines, and the concept has been invoked by Republicans as a sort of stand-in for vaccines. Florida wrote natural immunity into state law this week as GOP lawmakers elsewhere are pushing similar measures to sidestep vaccine mandates. Lawsuits over the mandates have also begun leaning on the idea. Conservative federal lawmakers have implored regulators to consider it when formulating mandates. (Izaguirre, 11/21)

The New York Times: Disney Puts Worker Vaccine Mandate On Pause After Florida Ban On Restrictions
Disney has put on pause a coronavirus vaccine mandate for employees of its Florida theme park after the State Legislature and the governor made it illegal for employers to require all workers get the shots, a company spokesperson confirmed Saturday. Walt Disney World could have been facing fines under the policy now on hold, illustrating how even one of the most iconic tourism brands in the state has to deal with the headwinds of political debate over the pandemic response. (Manuel Ramos, 11/21)

The New York Times: Virginia’s Lieutenant Governor-Elect Says She Doesn’t Support Mandates
Winsome Sears, the lieutenant governor-elect of Virginia, reaffirmed on Sunday that she did not support a sweeping vaccine mandate for Virginians like the rules implemented in New York City and elsewhere. “I’m not going to force anybody to do that,” Ms. Sears said on the CNN program “State of the Union.” She added, “I have said: Get the vaccine. And then if you’re not going to get the vaccine, then do what’s necessary to keep yourself safe and keep other people safe.” (Delkic, 11/21)

The Washington Post: Marine Corps Compliance With Vaccine Mandate On Course To Be Military’s Worst
Up to 10,000 active-duty Marines will not be fully vaccinated against the coronavirus when their deadline arrives in coming days, a trajectory expected to yield the U.S. military’s worst immunization rate. While 94 percent of Marine Corps personnel have met the vaccination requirement or are on a path to do so, according to the latest official data, for the remainder it is too late to begin a regimen and complete it by the service’s Nov. 28 deadline. Within an institution built upon the belief that orders are to be obeyed, and one that brands itself the nation’s premier crisis-response force, it is a vexing outcome. (Horton, 11/21)

AP: Health Workers Again Challenge Rhode Island's Vaccine Rule
A group of Rhode Island health care workers is again asking a federal judge to block the state’s requirement that people working in the medical profession be fully vaccinated against the coronavirus. A lawyer for eight people went before a federal judge on Friday seeking a preliminary injunction barring the state from enforcing the vaccine mandate, arguing that the state must provide a religious exemption if it offers a medical exemption, The Providence Journal reported. (11/20)

AP: Kansas Plan On COVID Mandates Faces Bipartisan Skepticism
Conservative Kansas legislators are trying to tamp down fears about the cost and other potential problems with their proposal to provide unemployment benefits to workers who lose their jobs for refusing COVID-19 vaccines. The GOP-controlled Legislature is expected to consider the measure during a special session that convenes Monday, along with another proposal that would make it easier for workers to claim religious exemptions to COVID-19 vaccine mandates. The measures are responses to vaccine mandates from President Joe Biden covering more than 100 million American workers. (Hanna, 11/22)

Fox News: Fauci Vague On Changing Definition Of 'Fully Vaccinated': 'We Might Modify'
"We’re going to take a look right now at what the durability is of the booster," Fauci told "State of the Union" host Dana Bash. "We’re going to follow people who get boosted." "People should not be put off by the fact that as time goes by and we learn more and more about the protection that we might modify the guidelines," he explained. "That’s what we’ve been saying all along by follow the science, things change and you have to follow the data." For now, the definition of fully vaccinated will remain as two shots of a Pfizer or Moderna regimen or one shot of a Johnson & Johnson vaccine. (Aitken, 11/21)

The Wall Street Journal: U.S. Covid-19 Deaths In 2021 Surpass 2020’s
The number of U.S. Covid-19 deaths recorded in 2021 has surpassed the toll in 2020, according to federal data and Johns Hopkins University, demonstrating the virus’s persistent menace. The total number of reported deaths linked to the disease topped 770,800 on Saturday, Johns Hopkins data show. This puts the pandemic-long total at more than twice the 385,343 Covid-19 deaths recorded last year, according to the most recent death-certificate data from the Centers for Disease Control and Prevention. (Kamp, Whelan and DeBarros, 11/21)

The Hill: COVID-19 Cases Rise With Thanksgiving Gatherings On The Way
COVID-19 cases are climbing nationally as the U.S. barrels into its second holiday season during the pandemic, with most families planning this year to gather for Thanksgiving. The U.S. is in better shape than at this point last year, when authorities confirmed well over 160,000 COVID-19 cases every day. The daily average of new cases stands below 100,000 and almost 200 million Americans are fully vaccinated. They can “feel good about enjoying a typical” holiday season, top infectious diseases expert Anthony Fauci said this week. (Coleman, 11/21)

The New York Times: Covid-19 Surge Strains Michigan’s Hospitals
The toll on hospitals is compounded by a staffing shortage that is rippling through the state’s health care system and a rise in people seeking medical help for issues not related to Covid-19, health leaders said. Covid-19 hospitalizations in the state are up 46 percent over the last two weeks, according to a New York Times database. The only other state with a higher spike in that time was New Hampshire, where hospitalizations increased 58 percent. Michigan had a higher per capita rate of hospitalizations than all but one state, North Dakota. Covid-19 cases in Michigan are up 78 percent over the last two weeks, according to The Times’s database. Only three states have bigger increases over that time. (Patel, 11/21)

Bangor Daily News: Maine CDC Reports Record COVID-19 Hospitalizations
COVID-19 hospitalizations have reached record numbers once again this month. On Sunday, 287 patients were hospitalized with the virus, according to data from the Maine Center for Disease Control and Prevention. The state’s previous record number of hospitalizations was set on Thursday, when 280 patients were hospitalized due to COVID-19. Currently, there are 80 patients who are in critical care beds, and 30 patients that are on a ventilator, according to Maine CDC data. (Lausier, 11/21)

Des Moines Register: Iowa COVID Cases Surging Again; Thanksgiving Gatherings Worry Experts
Just over a week before Thanksgiving, Dubuque County public health specialist Mary Rose Corrigan stared into a camera for a weekly PSA, and posed a rhetorical — but timely — question: Should people attend indoor, public events without masks or social distancing? Though delivered with a deliberate dose of Iowa nice, her answer for Dubuque residents was unmistakable: “Are you kidding me?” The number of COVID-19 cases in Iowa is again on the rise after a brief dip, as is the case in most neighboring states. In Minnesota, for one example, cases have risen so rapidly that emergency departments are overwhelmed, according to Minnesota Public Radio. (Coltrain, 11/20)

AP: Conn. COVID-19 Rate Is Rising Faster Than Other States
Connecticut is experiencing a more rapid increase in COVID-19 cases than any other state, according to the most recent statistics. The state has averaged 738 daily cases over the last week, which represents a 116% increase over two weeks earlier, the Hartford Courant reported. That’s higher than any other state for the same period. Four of the five states with the highest recent increase in virus cases are in New England, the newspaper reported. (11/22)

AP: COVID-19 Hospitalizations On The Rise In New York
New York is continuing to see an increase in COVID-19 cases and hospitalizations in November as the holiday season approaches, according to the latest state data released Saturday. Nearly 6,100 people a day are now testing positive for COVID-19 in New York — up 22% from roughly 5,000 for the seven days through Nov. 11. That’s the highest seven-day average since mid-April. (Villeneuve, 11/21)

Politico: VA Stats Show Devastating Covid Toll At Vets’ Nursing Homes
Almost a year after Congress passed a law requiring disclosure of Covid-19 deaths in veterans’ homes, the Department of Veterans Affairs finally began making public how many U.S. veterans got sick and died of the virus in special nursing homes meant to ease their final days. It now reports deaths of 1,498 home residents and 54 staff since late May 2020 at the special State Veterans Homes, which the VA finances and the states operate — and that number is likely to rise because data for some homes in hard-hit states is still missing or under VA review. (Kenen, Tahir and James Vestal, 11/19)

The New York Times: Britain Will Review Racial Bias In Medical Devices
Britain will conduct an independent review into whether medical devices used in the country have perpetuated racial and gender biases, the country’s health secretary said on Sunday, spurred by health disparities highlighted during the pandemic. “It is easy to look at a machine and assume that everyone’s getting the same experience,” wrote Sajid Javid in the Sunday Times. “But technologies are created and developed by people, and so bias, however inadvertent, can be an issue here too.” (Kwai, 11/21)

Reuters: UK Calls For Action On Racial Bias In Medical Devices
Britain called on Sunday for international action on the issue of medical devices such as oximeters that work better on people with lighter skin, saying the disparities may have cost lives of ethnic minority patients during the COVID-19 pandemic. Health Secretary Sajid Javid said he had commissioned a review of the issue after learning that oximeters, which measure blood oxygen levels and are key to assessing COVID patients, give less accurate readings for patients with darker skin. "This is systemic across the world. This is about a racial bias in some medical instruments. It's unintentional but it exists, and oximeters are a really good example of that," Javid said during an interview with the BBC. (11/21)

The New York Times: House Passes Biden’s Build Back Better Bill
The House narrowly passed the centerpiece of President Biden’s domestic agenda on Friday, approving $2.2 trillion in spending over the next decade to battle climate change, expand health care and reweave the nation’s social safety net, over the unanimous opposition of Republicans. The bill’s passage, 220 to 213, came after weeks of cajoling, arm-twisting and legislative legerdemain by Democrats. It was capped off by an exhausting, circuitous and record-breaking speech of more than eight hours by the House Republican leader, Representative Kevin McCarthy of California, that pushed a planned Thursday vote past midnight, then delayed it to Friday morning — but did nothing to dent Democratic unity. (Cochrane and Weisman, 11/19)

Politico: Dems’ $1.7T Spending Bill Clears House, But Senate Changes Loom
The House passed a sweeping $1.7 trillion spending bill Friday, a major step forward for the health care and climate package before action turns to the Senate, where an uncertain fate awaits. The behemoth bill is the most significant restructuring of the social safety net in decades, touching nearly every aspect of American life from universal pre-K to college assistance to elder care. Democrats also hope the landmark legislation can help them beat the historical odds and maintain full control of Congress next year. (Caygle, Ferris and Wu, 11/19)

Stat: Democrats’ Major Drug Pricing Reforms Clear A Hurdle In The House
House Democrats Friday broke a monthslong logjam and advanced prescription drug pricing reform policies as part of a broader domestic spending package. Despite a last-minute lobbying sprint by the pharmaceutical industry, the drug pricing deal Democrats announced earlier this month remained largely unchanged. The plan would allow Medicare to negotiate some drug prices, penalize drug makers that hike prices faster than inflation, and cap drug costs for seniors and patients who use insulin. (Cohrs, 11/19)

Bloomberg: Biden’s Doctors Say He’s ‘Healthy’ But Suffers Stiff Gait
President Joe Biden is “healthy” and remains “fit to successfully execute the duties of the presidency,” his doctors said Friday after he underwent a routine physical exam and colonoscopy just a day before his 79th birthday. But the president is suffering from a “perceptibly stiffer and less fluid” gait following a series of injuries and is experiencing a more frequent need to clear his throat or cough during public engagements, according to his physician, Kevin O’Connor. And his exam found mild nerve damage in the president’s feet, prompting them to suggest he be fitted with orthotics. (Epstein and Sink, 11/19)

Politico: Biden 'Fit For Duty' After Harris Is Temporarily Granted Powers During Medical Procedure
The White House released Joe Biden's health summary Friday — describing an active president who is "fit for duty" — hours after presidential power was temporarily transferred to Kamala Harris while Biden underwent a colonoscopy under anesthesia. The vice president worked from her West Wing office at the White House while the president underwent the procedure during his annual physical at Walter Reed National Military Medical Center, press secretary Jen Psaki said. (Niedzwiadek and Ward, 11/19)

Bloomberg: Biden Vaccine Coordinator Choucair Leaving White House
White House Vaccinations Coordinator Bechara Choucair is leaving the administration to return to the private sector, he said in a message Sunday to Bloomberg News. Choucair’s last day will be Monday. He joined President Joe Biden’s team during the transition last year and was charged with accelerating the nascent Covid-19 vaccination effort Biden inherited upon taking office in January. A White House spokesman didn’t immediately respond to an email seeking comment Sunday night. Choucair, a former Chicago health commissioner and senior executive at Kaiser Permanente, is departing after the U.S. expanded access to vaccines for all people over age 5 and widely approved booster doses for adults. (Tozzi, 11/22)

Modern Healthcare: House-Passed Bill Would Mandate Some Staffing Changes
Nursing homes across the country would need to meet new staffing requirements under a domestic policy package that passed the House Friday, a change the industry says would force facilities to close but which advocates say is sorely needed. The $1.75 trillion package, which awaits approval from the Senate, directs the Health and Human Services Department to issue regulations on "appropriate" minimum staffing ratios at skilled nursing facilities, which would mark the first update to the law since the 1980s. (Hellmann and Goldman, 11/19)

Politico: New GOP Weed Approach: Feds Must ‘Get Out Of The Way’
“We need the federal government just to get out of the way,” said Rep. Nancy Mace (R-S.C.), who introduced the first Republican bill in Congress to decriminalize marijuana this past week and pointed to more than 70 percent of Americans supporting the idea. Stronger Republican involvement could hasten a snowball effect on Capitol Hill, where Democrats lead the charge on decriminalization but lack results. It could also chip away at Democrats’ ability to use cannabis legalization to excite progressives and younger voters as the midterms approach. (Fertig and Zhang, 11/21)

The Washington Post: Facebook Knew Its Algorithms Were Biased Against People Of Color
“Even though [Facebook executives] don’t have any animus toward people of color, their actions are on the side of racists,” said Tatenda Musapatike, a former Facebook manager working on political ads and CEO of the Voter Formation Project, a nonpartisan, nonprofit organization that uses digital communication to increase participation in local state and national elections. “You are saying that the health and safety of women of color on the platform is not as important as pleasing your rich White man friends.” (Dwoskin, Tiku and Timberg, 11/21)

The Washington Post: More Americans Say They’re Not Planning To Have A Child, Pew Poll Says
More U.S. adults who do not already have children are saying they are unlikely to ever have them, a new Pew Research Center survey finds — findings that could draw renewed attention to the risks of declining birthrates for industrialized nations. Experts are concerned that the U.S. birthrate, which has declined for the sixth straight year, may not fuel enough population growth on its own to keep the future economy afloat and fund social programs. Women between the ages of 18 to 49 and men between 18 and 59 who said they are not parents were asked the question, “Thinking about the future, how likely is it that you will have children someday?” (Timsit, 11/21)

The Hill: More Americans Say Its Unlikely They Will Ever Have Children: Poll 
An increasing portion of Americans say they are unlikely to ever have children, according to a new Pew Research Center survey. Forty-four percent of current non-parents between ages 18 and 49 said they are unlikely to have children someday, marking an increase from 37 percent of respondents in 2018, according to the survey. Just 26 percent of people in that group said they were "very likely" to have children someday, down from 32 percent in 2018, according to the poll. (Beals, 11/21)

The Washington Post: For Many Men, Apps Can Be ‘An Important Gateway To Mental Health’
The online help provides a “less intimidating entry to mental health,” says C. Vaile Wright, a psychologist who is senior director of health-care innovation for the American Psychological Association. “They are an important gateway to mental health for many men who need help but never considered reaching out for it before. ”Research has show that men often avoid seeking help because of gender expectations that they should not appear vulnerable or unable to handle their own problems, according to one recent study. They seek help for mental health struggles at approximately half the rate of women. Yet research has also shown that men are four times more likely to commit suicide than women, are more likely to abuse and die of drugs, especially opiates, as well as alcohol, and are at the forefront of the loneliness epidemic. (Reiner, 11/20)

The Wall Street Journal: Covid-19 Breakthrough Hospitalizations Concentrated Among Most Vulnerable
Breakthrough cases of Covid-19 are hitting older people and those with underlying health conditions particularly hard, according to a new review of data by The Wall Street Journal that sharpens the picture of who remains at risk despite vaccinations. State reporting is inconsistent but collectively shows there have been more than 1.89 million cases and at least 72,000 hospitalizations and 20,000 deaths among fully vaccinated people in the U.S. this year, the Journal found. (Kamp and Evans, 11/21)

CIDRAP: Poorer Nations Got Fewer Doses Of The COVID Vaccines They Helped Test
High-income countries have received disproportionately more COVID-19 vaccine doses than low- and middle-income countries, allowing them to vaccinate much more of their populations, finds a study yesterday in JAMA Network Open. Yale University researchers identified COVID-19 vaccines listed by the World Health Organization for emergency use and all vaccine trials completed by Sep 7, 2021. (11/19)

AP: COVID-19 Increases Stillbirths During Pregnancy: Research
Pregnant women who become infected with the delta variant face a significantly higher risk of a stillbirth or dying during childbirth, new studies show. The Centers for Disease Control and Prevention released a report Friday that examined 1.2 million deliveries in 736 hospitals nationwide from March 2020 through September 2021. Stillbirths were rare overall, totaling 8,154 among all deliveries. But researchers found that for women with COVID-19, about one in 80 deliveries resulted in a stillbirth. Among the uninfected, the rate was one in 155. (11/21)

CIDRAP: Full ICUs Amid COVID Surges Could Lead To Thousands Of Extra Deaths
A modeling study today in Morbidity and Mortality Weekly Report estimates that 12,000 more people die 2 weeks after US hospitals reach 75% adult intensive care unit (ICU) occupancy amid COVID-19 pandemic surges, a figure that rises to 80,000 when ICUs are full—which is the case now in many hospitals in multiple US states. Researchers from the US Department of Homeland Security's Cybersecurity & Infrastructure Security Agency COVID Task Force evaluated the relationship between overwhelmed hospitals and excess deaths from Jul 4, 2020, to Jul 10, 2021. The end of the study period included the emergence and eventual dominance of the more transmissible Delta (B1617.2) variant. (Van Beusekom, 11/19)

NPR: Why People With Mental Illness Are at Higher Risk of COVID
Even before the federal government's recent decision last week to authorize COVID boosters all adults, it had already recommended them in October for people with certain high-risk conditions. Along with with illnesses like diabetes and heart disease, that list included mental health conditions. The decision to prioritize people with psychiatric diagnoses in the early rollout of boosters came after after a growing number of studies linked mental health disorders with higher risk of both COVID-19 infection and of serious outcomes. (Chatterjee, 11/22)

Modern Healthcare: COVID-19 Crisis Paves Way for At-Home Endoscopy
Late last year, gastroenterologist Dr. Michael Bass decided to try out a new program: an endoscopy that patients would complete at home, with his support, over telehealth. The COVID-19 crisis essentially shut down operations at the private practice Bass sees patients at, GI Specialist of Delaware, for some of 2020, as in-person procedures were canceled or deferred in the early days of the pandemic. Even since then, patients have been hesitant to return to the office, Bass said. He needed a way to move as much care as possible out of the practice, and like many physicians, turned to telehealth. (Kim Cohen, 11/19)

Stat: FDA Approves First Drug For Genetic Cause Of Dwarfism 
The Food and Drug Administration approved the first treatment for the most common cause of dwarfism Friday, a drug that has proved to increase children’s height but has been polarizing among adults with short stature. The treatment, developed by BioMarin Pharmaceutical, is a once-daily injection for children with achondroplasia, a rare genetic disorder that results in dwarfism and can lead to serious medical complications. In a pivotal clinical trial, patients who got the drug, called Voxzogo, grew 1.6 centimeters more over the course of a year than those who received placebo. That means patients who take Voxzogo throughout childhood are likely to reach heights similar to their peers who don’t have achondroplasia, according to BioMarin. (Garde, 11/19)

CIDRAP: Staphylococcus Bloodstream Infections Rising In Europe, Study Finds
In another surveillance study published yesterday in Eurosurveillance, European researchers reported a significant increase across the continent in Staphylococcus aureus bloodstream infections (BSIs), despite a decline in BSIs caused by methicillin-resistant S aureus (MRSA). The analysis of data from the European Antimicrobial Resistance Surveillance Network (EARS-Net) for 2005 through 2018 found that, in the 25 EU/EEA countries that consistently reported data on S aureus BSIs, the proportion of BSIs caused by MRSA declined from 30.2% in 2005 to 16.3% in 2018. The percentage of MRSA BSIs declined across all age-groups. (11/19)

CIDRAP: CDC Closes Salmonella Backyard Poultry Outbreak Probe After 1,135 Cases
The CDC yesterday added 272 cases to an ongoing Salmonella outbreak tied to backyard poultry, with 1,135 now confirmed sick in 48 states, the District of Columbia, and Puerto Rico. The CDC also said it has closed its investigation into the outbreak. Two people died from Salmonella infections during this outbreak, and 273 required hospitalization. Illnesses started on dates ranging from Dec 15, 2020, to Oct 10, 2021. Twenty-four percent of those sick were under 5 years, and 12% were under 1 year. Of 1,107 people with sex information available, 646 (58%) were female. (11/19)

CIDRAP: FAO Plan Aims To Counter Antibiotic Resistance In Food, Ag Sectors
Citing the rising threat posed by antimicrobial overuse to the food and agriculture sectors, the United Nations Food and Agriculture Organization (FAO) today released a new 5-year action plan on antimicrobial resistance (AMR). With the world expected to produce as much food over the next 30 years as it has in the past 10,000, and antimicrobial use in livestock expected to double to keep up with demand, the FAO says now is the time to help countries strengthen their capacities to manage AMR risks in the food and agriculture sectors. Doing so will not only buy time for the discovery and development of new drugs, the agency argues, but also help build more sustainable, resilient food systems. (Dall, 11/19)

Stat: A New, Gel-Based Wearable Can Catch Infections Before The Naked Eye Can
A team of researchers has designed a wearable sensor that, in preliminary testing, identified infections in open wounds before they looked any different than uninfected wounds. Their sensor, which combines principles from biology, materials science, and electrical engineering, may one day be a low-cost, time-saving alternative to existing diagnostic tools. (Bender, 11/19)

AP: Cap On Drug Price Hikes For Privately Insured Sparks Battle
Workers and families with private health insurance would reap savings on prescription drugs from a little-noticed provision in President Joe Biden’s sweeping social agenda bill. It’s meant to break the cycle of annual price increases for widely used medicines. That provision would require drug companies to pay rebates to Medicare if they increase prices above the rate of inflation. Drugs sold to private plans would count in calculating the penalty, like a tax on price increases. The issue is dividing business groups in a fierce lobbying battle. (Alonso-Zaldivar, 11/21)

The Wall Street Journal: Novartis Rethinks Sales Strategy For New Cholesterol Drug Launch
Novartis AG NVS -0.38% bet big on its new cholesterol-busting drug. To overcome the tricky market for new heart medicines, it is pursuing an unconventional strategy that turns the traditional drug launch on its head. Rather than seeking to grab the attention of patients and winning support from individual physicians, the Swiss pharmaceutical giant is focusing on the people who run large hospital systems. Its pitch: A large-scale rollout of the drug, called Leqvio, could avert thousands of heart attacks and strokes. (Roland, 11/21)

Stat: Flagship Pioneering’s Noubar Afeyan On Moderna's 'Crazy' Path
On his desk — placed so its visible on his Zoom calls — Flagship Pioneering founder and CEO Noubar Afeyan has a plaque imploring those who see it to “trust your crazy ideas.” It’s effectively a slogan for Flagship Pioneering, the brazen venture capital firm behind Moderna. (Sheridan, 11/21)

Stat: Verily’s Amy Abernethy Hints At Clinical Trial Blueprint For 2022
Verily’s quest to become a major player in the life sciences has resulted in a scattershot string of efforts, but as the company plans for 2022, charging forward with its clinical trial strategy will be the Alphabet spinout’s priority. Speaking at the 2021 STAT Summit, Amy Abernethy, president of Verily’s clinical trials platform, said that company is gearing up to release a new “blueprint” for its future in the space, and spelled out some of the pillars of the approach. The company’s strategy includes making it easier for a diverse pool of people to participate in trials, enabling more robust data collection, and preparing for more complex study designs that the first two pillars enable. (Aguilar, 11/19)

Modern Healthcare: Bain Capital Nabs Majority Stake In InnovaCare
Bain Capital Private Equity invested an undisclosed sum in InnovaCare Health on Friday, making the private equity powerhouse a majority owner of the value-based primary care provider group. The new investment ousts Summit Partners from its majority stake in the 23-year-old system. InnovaCare will continue to be led by CEO Dr. Richard Shinto and the current management team, who will also retain significant ownership in the business. The company's primary care provider network currently treats more than 250,000 patients annually, including 27,000 Medicare Advantage members. (Tepper, 11/19)

Modern Healthcare: TriHealth To Construct $30M Ambulatory Campus In Underserved Community
TriHealth is planning to build a large medical campus in near its headquarters in Cincinnati, as a "one-stop shop" for care, the not-for-profit health system announced. The Finneytown, Ohio, facility will be two stories with an area of 55,000 square feet and is expected to be completed in mid-2023, the health system announced on Friday. Recruitment is currently underway to staff the ambulatory campus with 18 to 20 primary care providers. (Devereaux, 11/19)

Baltimore Sun: Nurses From University Of Maryland To Graduate Early And Head To The Pandemic Front Lines
Seeking to ease a nursing shortage exacerbated by the coronavirus pandemic, the University of Maryland School of Nursing will allow nursing students to exit a bit early and begin working in the field. It’s the fourth time the school has approved such a move, which affects students scheduled to graduate Dec. 23. (Cohn, 11/21)

AP: New Orleans EMS Director Quits Amid Staffing Shortages
There’s a vacancy in the top post of New Orleans Emergency Medical Services. The director, Dr. Emily Nichols, is resigning after more than three years in the job, a spokesperson for the agency said Friday. Nichols told her paramedics that she was leaving the agency, which has been hit by staffing shortages worsened by the coronavirus pandemic. The agency intended to announce the resignation Monday, spokesperson Jonathan Fourcade said. (11/21)

AP: Rhode Island Awarded $81.7M Federal Grant For New Health Lab
Rhode Island’s congressional delegation announced the new federal Epidemiology and Laboratory Capacity grant. They say the current facility, commissioned in 1978, has insufficient laboratory space, inadequate building systems and broken equipment, and the state spends more than $500,000 annually to keep it working efficiently. The state health laboratories work to investigate and mitigate life-threatening diseases, including COVID-19, eastern equine encephalitis, Ebola, H1N1, and Zika. Last year, when commercial testing services weren’t yet widely available, the number of COVID-19 samples that could be tested was limited due to insufficient laboratory space, the delegation said. (11/21)

The Washington Post: Europe Protests: Clashes In Rotterdam And Rallies In Rome Amid New Pandemic Restrictions
Protests against coronavirus restrictions erupted across Europe — including clashes in Rotterdam and massive rallies in Vienna — as authorities announced more-stringent measures in an attempt to control rising cases ahead of the winter holidays. At least seven people were injured and more than 50 arrested after protests in Rotterdam turned violent late Friday, with protesters throwing stones and police firing shots, according to Dutch police. Demonstrators decried a proposed law that would ban unvaccinated people from entering businesses even if they provide a negative test. They also protested a partial lockdown that went into effect last week and will last until at least Dec. 4, which forces restaurants and other establishments to close at 8 p.m. (Stein, 11/20)

Bloomberg: Javid Says ‘Plan B’ Not Needed, Confirms Racial Bias Probe
There’s no need yet for the U.K. to implement “Plan B” to clamp down on persistently high Covid infection levels, said U.K. Health Minister Sajid Javid. Separately, Javid confirmed that the U.K. would follow the lead of U.S. health agencies and review what he called possible “systemic racial bias” in certain medical devices and “in health services across the world.” On Sky News, Javid said expanding the vaccine booster program would be the key to a Christmas season without new restrictions. (Krasny and Sidders, 11/21)