First Edition: Sept. 10, 2021

KHN: It’s Not Just Covid: Recall Candidates Represent Markedly Different Choices On Health Care 
Gov. Gavin Newsom’s covid-19 rules have been a lightning rod in California’s recall election. But there’s a lot more at stake for Californians’ health care than mask and vaccine mandates. Newsom, a first-term Democrat, argues that their fundamental ability to get health insurance and medical treatments is on the line. Republicans are seeking to “take away health care access for those who need it,” according to his statement in the voter guide sent to Californians ahead of Tuesday’s recall election. (Young and Bluth, 9/10)

KHN: ECMO Life Support Is A Last Resort For Covid, And In Short Supply In South
Hospital discharge day for Phoua Yang was more like a pep rally. On her way rolling out of TriStar Centennial Medical Center in Nashville, Tennessee, she teared up as streamers and confetti rained down on her. Nurses chanted her name as they wheeled her out of the hospital for the first time since she arrived in February with covid-19, barely able to breathe. The 38-year-old mother is living proof of the power of ECMO — a method of oxygenating a patient’s blood outside the body, then pumping it back in. Her story helps explain why a shortage of trained staff members who can run the machines that perform this extracorporeal membrane oxygenation has become such a pinch point as covid hospitalizations surge. (Farmer, 9/10)

KHN: KHN’s ‘What The Health?’: The Future Of Public Health 
The covid-19 pandemic has shone a spotlight on public health, a key part of the health care system that usually operates in the background. Public health has, over the past century, helped ensure that Americans have clean water to drink, untainted food to eat and vaccines that have helped obliterate once-common deadly diseases. But like other issues related to the pandemic, public health has become politicized and controversial, leading some public health officials to quit or retire. Some even have been physically threatened just for doing their jobs, trying to keep people healthy and safe. (9/9)

The New York Times: Biden Mandates Vaccines For Workers, Saying, ‘Our Patience Is Wearing Thin’ 
Mr. Biden is acting through a combination of executive orders and new federal rules. Under his plan, private-sector businesses that have 100 or more employees will have to require vaccination, or mandatory weekly testing, after the Occupational Safety and Health Administration drafts a rule. Roughly 17 million health care workers employed by hospitals and other institutions that accept Medicare and Medicaid reimbursement will also face strict new vaccination requirements, as will federal contractors and most federal workers. (Rogers and Stolberg, 9/9)

The New York Times: Biden’s Vaccine Push: What You Need To Know 
Moving aggressively to combat the spread of the Delta variant, President Biden announced a six-part plan on Thursday that would touch on nearly every aspect of society, in what amounted to the most expansive use of his presidential authority since he took office in January. Here is what is in the plan. (Kavi, 9/9)

The Hill: Education Department Promises Support To Districts Penalized For COVID-19 Measures
The Department of Education is promising to support school districts that get penalized for their COVID-19 protocols, unveiling on Thursday a grant program to provide the districts funding. The agency on Thursday unveiled Project Supporting America's Families and Education (SAFE), which will provide funding for districts that had money withheld because they implemented measures such as universal indoor masking.  (Williams, 9/9)

AP: Federal Mandate Takes Vaccine Decision Off Employers' Hands
Larger U.S. businesses now won’t have to decide whether to require their employees to get vaccinated against COVID-19. Doing so is now federal policy. ... Large swaths of the private sector have already stepped in to mandate shots for at least some of their employees. But Biden said Thursday that “many of us are frustrated with the nearly 80 million Americans who are not fully vaccinated.” ... The Associated Press reached out to a wide range of companies on Thursday. Many didn’t have immediate responses while others noted that they already require vaccinations. Walmart, the nation’s largest private employer, was one of the first major companies to mandate vaccines for some of its workers. Walmart said in late July that it was requiring that all workers at its headquarters in Bentonville, Arkansas, as well as its managers who travel within the U.S.; be vaccinated against COVID-19 by Oct. 4. (Ortutay, 9/10)

Bloomberg: Businesses Question Logistics, Cost Of Biden Vaccine Plan
U.S. companies grappling with the thorny issue of whether to require worker vaccinations against Covid-19 say the U.S. government needs to provide more details about a new, far-reaching mandate announced Thursday. President Joe Biden’s directive requires vaccinations for all executive-branch employees, federal contractors and millions of health-care workers, while large private employers must either mandate shots or provide weekly testing. Businesses are now digesting the order, but there are concerns over what the mandate may entail. (Roeder, 9/10)

The New York Times: New Mandate Raises Question: Who’ll Pay For All The Covid Tests? 
Spurred by persistently high Covid case numbers and only modest vaccination rates, the Biden administration announced Thursday a new effort to combat the pandemic. It intends to mandate that workers at large companies get vaccinated, or submit to regular testing. The rule applies to tens of millions of Americans, about two-thirds of the country’s work force. And it raises a thorny question: Who pays for those coronavirus tests? (Kliff, 9/9)

The Washington Post: Republican Governors Threaten To Sue Over Biden’s Sweeping Vaccine Mandates 
Republican leaders in the United States are blasting President Biden’s sweeping new coronavirus vaccine mandates for businesses and federal workers, decrying them as unconstitutional infringements on personal liberties and promising to sue. ... Republican governors from Texas to Missouri and Georgia threatened to fight back. Texas Gov. Greg Abbott called the mandates “an assault on private businesses” and said the state is “already working to halt this power grab.” Wyoming Gov. Mark Gordon said he asked his state’s attorney general “to stand prepared to take all actions to oppose this administration’s unconstitutional overreach of executive power,” as South Dakota Gov. Kristi L. Noem said “see you in court.” Republican National Committee Chairwoman Ronna McDaniel also said the group “will sue the administration to protect Americans and their liberties.” (Timsit and Pietsch, 9/10)

NBC News: RNC Says It Plans To Sue Biden Administration Over Federal Vaccination Mandate
The Republican National Committee said Thursday that it plans to sue the Biden administration after the president issued two sweeping executive orders that will require Covid vaccinations for as many as 100 million people in the U.S. RNC Chairwoman Ronna McDaniel said the mandate was "unconstitutional" in a statement. "Joe Biden told Americans when he was elected that he would not impose vaccine mandates. He lied. Now small businesses, workers, and families across the country will pay the price," she said. (Clark, 9/9)

CNN: 'Show Some Respect:' Biden Blasts Travelers Who Harass Flight Attendants Over Face Masks 
President Joe Biden on Thursday blasted travelers who harass flight attendants because they don't want to wear a face mask and announced fines would double for those who don't comply with the US federal transportation mask mandate. "If you break the rules, be prepared to pay," Biden said, speaking from the White House. "And by the way, show some respect. The anger you see on television toward flight attendants and others doing their job is wrong. It's ugly." (Sullivan and Wallace, 9/9)

The Washington Post: Rep. Don Beyer Introduces Bill To Require Vaccines Or Negative Coronavirus Test For Domestic Travel
Rep. Don Beyer (D-Va.) introduced a bill on Thursday to require all domestic travelers to show proof of vaccination or a negative coronavirus test at airports or for Amtrak trips, seeking to revive largely stagnant discussions among federal officials about more restrictive pandemic travel requirements. The bill, the Safe Travel Act, would also require all Amtrak, airport and air carrier employees or contractors to be vaccinated or submit to weekly testing. Unvaccinated travelers would have to present a negative test within 72 hours before travel. (Flynn and Aratani, 9/9)

Stat: FDA Misses Deadline For Deciding On E-Cigarette Products
The Food and Drug Administration announced Thursday that it has failed to meet a court-ordered deadline for deciding which e-cigarette products can stay on the market. In fact, it has yet to rule on whether any of the largest and most controversial e-cigarette companies, including JUUL, can keep selling their products. (Florko, 9/9)

USA Today: FDA Delays Juul Decision, Rejects 950K Vaping Product Applications
The U.S. Food and Drug Administration on Thursday banned the sale of hundreds of thousands of vaping and electronic cigarette products, but delayed its decision on the industry's leading company, Juul. The agency faced a court deadline to issue decisions on marketing applications from the vaping giant and hundreds of other companies after anti-tobacco groups successfully sued the agency to speed up its review. Regulators previously said they would prioritize Juul and a handful of other key players, but none were included in the agency's announcement. (Rodriguez, 9/9)

Politico: DOJ Sues Texas Over Abortion Law
The Biden administration on Thursday sued the state of Texas over its highly restrictive abortion law that the Supreme Court allowed to take effect last week. “The act is clearly unconstitutional under longstanding Supreme Court precedent,” Attorney General Merrick Garland said in a news conference. “This kind of scheme to nullify the Constitution of the United States is one that all Americans, whatever their politics or party, should fear.” (Niedzwiadek and Gerstein, 9/9)

CNN: Stephen Breyer Calls Supreme Court Decision On Texas Abortion Law 'Very, Very, Very Wrong' 
US Supreme Court Justice Stephen Breyer called the high court's recent refusal to block a controversial Texas law that bars abortions at six weeks "very, very, very wrong." "I'll add one more 'very,' " the liberal Justice told NPR in an interview published Thursday. "And I wrote a dissent. And that's the way it works." Breyer's comments build on his pointed dissent in the Supreme Court's 5-4 ruling that allowed the Texas law -- which is one of the strictest in the nation and bans abortion before many people know they are pregnant -- to remain on the books. (LeBlanc, 9/9)

The New York Times: As Abortion Rights Expand, The U.S. Joins A Handful Of Telling Exceptions 
The story of abortion rights in the 21st century can be seen in two world-shaking developments this past week. In the first, the U.S. Supreme Court effectively upheld drastic new abortion restrictions in Texas. A few days later, Mexico’s high court paved the way for nationwide legalization. It may be tempting to see Mexico’s ruling as the more surprising, catapulting the world’s second most populous Catholic country on a deeply contentious social matter. But experts say it is the United States that stands out. (Fisher, 9/9)

Indianapolis Star: Federal Appeals Court Says Indiana Can Keep Enforcing Abortion Laws
A federal appeals court has said Indiana can continue enforcing five abortion restrictions while the state appeals the original lawsuit challenging those restrictions. In an order issued Wednesday two judges with the Seventh Circuit Court of Appeals said Indiana's challenged abortion laws, which a federal judge in Indiana said were unconstitutional in August, can remain in place because the state may win its legal case in favor of those laws in the long-term. "All we hold today is that existing precedents provide strong grounds for concluding that Indiana is likely to prevail on the contested issues," the two judges wrote after citing past U.S. Supreme Court cases. (Magdaleno, 9/9)

The Washington Post: ‘Roe Baby’ Whose Conception Sparked Landmark Abortion Ruling Comes Forward To Share Her Name — And Her Story
The child of “Jane Roe,” whose conception brought about the Supreme Court’s decision in Roe v. Wade on a woman’s legal right to an abortion, came forward for the first time Thursday after decades of secrecy where she was known only as the “Roe baby.” Shelley Lynn Thornton was publicly identified in an excerpt published in the Atlantic of journalist Joshua Prager’s upcoming book “The Family Roe: An American Story,” which explores those connected to the landmark 1973 case. In the excerpt, Thornton, 51, of Tucson, opened up about her life and the complex family history connected to the “Roe baby” over the last half-century. (Bella, 9/9)

The Hill: House Democrats Unveil Proposals On Drug Prices, Medicaid Expansion 
House Democrats on Thursday unveiled a range of health care measures to be included in their coming $3.5 trillion package, including provisions to lower prescription drug prices and expand Medicaid in the 12 GOP-led states that have refused to do so. The measure unveiled by the House Energy and Commerce Committee ahead of consideration next week includes House Democrats’ signature legislation to allow the Secretary of Health and Human Services to negotiate lower drug prices, known as H.R. 3. (Sullivan, 9/9)

Modern Healthcare: House Democrats Propose ACA Subsidies For Medicaid Expansion Gap
More than 2 million low-income people who live in states that have rejected the Affordable Care Act's Medicaid expansion would get help buying coverage on the ACA's exchanges under a bill released Thursday by a congressional committee. The U.S. House of Representatives' Energy and Commerce Committee released its portion of the $3.5 trillion health, education, labor and social services package congressional Democrats hope to pass this year, proposing permanent coverage of people who fall in the Medicaid expansion gap in states like Texas and Florida. Through 2024, those individuals would be eligible for ACA premium tax credits with enhanced cost-sharing assistance. (Hellmann, 9/9)

Politico: Biden Admin Backs Direct Government Drug Price Negotiations 
A new Biden administration plan aimed at lowering prescription drug prices endorses giving the government sweeping power to directly negotiate the cost of medicines, calling it one of the key steps Congress could take to make drugs “more affordable and equitable” for all Americans. The plan — developed by the Department of Health and Human Services and released on Thursday — largely backs Democrats’ ongoing efforts to lower drug prices as part of a $3.5 trillion reconciliation proposal, and mirrors a range of legislative options that both House and Senate lawmakers have floated in recent years. (Cancryn, 9/9)

Stat: Biden Plan To Lower Drug Prices Drawn From Familiar Democratic Playbook
The Biden administration on Thursday unveiled a long-awaited plan to lower prescription drug prices that included a number of aggressive proposals but largely tread over ideas that Democrats have pushed for years. The plan would allow Medicare to negotiate drug prices with manufacturers, a longstanding pledge from Biden, Democratic lawmakers, and every Democratic presidential candidate in 2020. It also would limit yearly price increases, allow the importation of drugs from Canada, and place a cap on out-of-pocket spending for Medicare beneficiaries. (Facher, 9/9)

The Hill: House Democrat Says She'll Oppose Parts Of $3.5T Spending Package
Rep. Stephanie Murphy (Fla.), a prominent moderate House Democrat, indicated Thursday that she is planning to vote against the provisions under consideration in the House Ways and Means Committee's markup of portions of Democrats' $3.5 trillion spending bill, citing concerns about the legislative process. "Despite this committee's extraordinary efforts, I find myself in an impossible situation, " she said, adding that she expects to vote "no," "unless something changes." (Jagoda, 9/9)

NPR: Amy Klobuchar Announces She Had Breast Cancer Earlier This Year
Sen. Amy Klobuchar, D-Minn., announced Thursday that she underwent radiation treatment for breast cancer earlier this year and her doctors recently confirmed that the treatment went well. "Of course this has been scary at times, since cancer is the word all of us fear, but at this point my doctors believe that my chances of developing cancer again are no greater than the average person," Klobuchar said in a post on Medium. The Minneapolis Star Tribune reports Klobuchar, 61, "was sitting in her apartment in Washington, D.C. waiting to cast a vote on the pandemic federal stimulus package when she got the news." (Farrington, 9/9)

Los Angeles Times: L.A. School District Approves Student COVID Vaccine Mandate
All children 12 and older in Los Angeles public schools must be fully vaccinated against COVID-19 by January to enter campus under an order approved Thursday by the Board of Education, the first such mandate among the nation’s largest school systems and a decision that triggered immediate pushback. The requirement cements the standing of the L.A. Unified School District as an early adopter of COVID-19 school safety measures that are wide-reaching and aggressive. The nation’s second-largest school system has moved faster and more comprehensively than most others in testing all students and employees for coronavirus infection every week, requiring masks indoors and outdoors and ordering employees to get vaccinated. (Blume and Gomez, 9/9)

AP: Kentucky Lawmakers Scrap Statewide Mask Mandate In Schools
Kentucky lawmakers, many not wearing masks, voted Thursday to scrap a statewide mask mandate in public schools and shifted masking decisions to local school boards, acting in a special session as the state’s worst COVID-19 surge threatens to overwhelm hospitals. The GOP-dominated legislature set education policies in response to disruptions caused by the virus, which has forced dozens of school districts to close classrooms. The masking provisions sparked emotional debate on the third and final day of the special session called by the Democratic governor to address the pandemic. (Schreiner, 9/10)

CNN: Florida Gov. Ron DeSantis Files Emergency Appeal On School Mask Mandates 
Lawyers for Florida Gov. Ron DeSantis have filed an emergency appeal with the First District Court of Appeals in Florida in hopes of halting school mask mandates while the case goes through the court system. DeSantis' lawyers argue they "have a high likelihood of success on appeal. Therefore, the trial court abused its discretion in vacating the automatic stay, and this Court should reinstate the stay pending review," according to a court document. (Simon, 9/9)

AP: Loophole Allows Some Pennsylvania Students To Avoid Masking
An apparent loophole in Pennsylvania’s mask mandate for schools is making it easier for some students to go to class without having to cover their faces, even as state education regulators sought to make an example of one openly defiant school board. The state health secretary’s order requiring masks to be worn inside K-12 school and child care facilities, which took effect Tuesday, includes an exemption for students who claim it would cause or worsen a medical condition. (Rubinkam, Scolforo and Levy, 9/10)

CNN: North Carolina Sounds Alarm That Nearly Half Of State's Middle And High School Covid-19 Clusters Tied To Sports 
Forty-five percent of all Covid-19 clusters in North Carolina's middle and high schools since July have been among sports teams, according to the North Carolina Department of Health and Human Services (NCDHHS). The state's department of health said it was seeing a "sharp increase" in clusters among sports teams. (Simon, 9/9)

NBC News: Tennessee Teen Talking About Grandma Who Died Of Covid Heckled By Adults At School Board Meeting
A Tennessee teenager who was mocked by adults as he defended masks by explaining his grandmother died of Covid-19 called the moment “complete insanity.” Grady Knox, a junior at Central Magnet School, was mocked and shouted down while speaking at a Rutherford County School Board meeting Tuesday night. A clip of the moment made the rounds of social media, showing adults telling the teenage boy to “shut up” as he gave a personal story to relay his views in favor of mask mandates. (Madani, 9/9)

The Washington Post: University Of Delaware Warns Faculty Not To Tell Students About Covid-19 Cases In Class 
The University of Delaware is warning its faculty not to tell students if their classmates get a confirmed case of the coronavirus. The change in protocol, sent in an email on Wednesday reviewed by The Washington Post, comes as rising cases on campus resulted in the university’s special accommodations for those who have covid-19 filling up. The email said that “if an instructor is notified by a student that the student has covid-19, the instructor may not tell the class that someone has tested positive for covid-19.” (Pietsch, 9/9)

AP: Judge Extends Block Of Western Michigan Vaccine Mandate
A federal judge on Thursday extended his order blocking Western Michigan University from enforcing a COVID-19 vaccine requirement against 16 athletes. U.S. District Judge Paul Maloney issued a ruling from the bench granting the athletes the right to continue to compete and participate in intercollegiate athletics until he issues an opinion and order on converting a temporary restraining order into a preliminary injunction. (9/9)

AP: Washington State To Require Masks For Large Outdoor Events
Washington Gov. Jay Inslee announced Thursday that starting next week, the state’s indoor mask mandate will be expanded to include outdoor events with 500 or more attendees, regardless of vaccination status. The new requirement — which takes effect Monday — comes days after a similar outdoor mask mandates took effect in the state’s two most populous counties, King and Pierce, due to rising COVID-19 cases. An indoor mask mandate, regardless of vaccination status, has been in place in Washington since Aug. 23. (La Corte, 9/9)

USA Today: Miami Airports Tests Out COVID-19 Detecting Dogs In Airport First
The power of a dog's nose could be the latest COVID-19 detection tool for travelers. Miami International Airport is two weeks into a pilot program using two COVID-19 detecting canines to screen American Airline employees for the virus at a security checkpoint, according to airport officials in a news release Thursday. In an airport first, Miami has partnered with the Global Forensic and Justice Center at Florida International University and American Airlines to screen employees. If successful, it may move to busier parts of the airport. (Gilbert, 9/9)

Journal Star: COVID Hospitalizations In Illinois Surging Among Pregnant Women
A recent surge in the number of pregnant women hospitalized for COVID-19 is causing Dr. Michael Leonardi to lose sleep. Leonardi is an OB-GYN with OSF HealthCare who specializes in high-risk pregnancies. He said there was a dramatic jump in the number of pregnant COVID-19 patients hospitalized at OSF Saint Francis Medical Center between July and August. “The last weekend that I was on call, one-third of labor and delivery beds were taken up by women with COVID who had no reason other than COVID to be in the hospital,” said Leonardi. “I can think of two people recently who were intubated and on ventilators in the ICU and delivered early because of COVID. I am concerned that we're on the  beginning of an upsurge." (Renken, 9/9)

Las Vegas Review-Journal: About 40 Cases Of Mu Coronavirus Variant Detected In Nevada
There have been roughly 40 cases identified in Nevada of the mu variant of the coronavirus, the latest troubling strain to join the World Health Organization’s watchlist, a top state public health official said. In designating mu a “variant of interest” on Aug. 30, WHO said it possesses a constellation of mutations that could make it resistant to the protection against disease afforded by vaccination or past COVID-19 infection. Despite the designation, the head of the Nevada State Public Health Laboratory thinks it’s unlikely that mu (pronounced “mew”) will overtake the highly contagious delta mutant as the state’s dominant strain. (Hynes, 9/9)

CNBC: Delta Air Lines’ $200 Per Month Experiment For Changing Unvaccinated Employees’ Minds Seems To Be Working
Americans infamously vote with their wallets. Turns out, they may get vaccinated against Covid with their wallets, too. In the two weeks since Delta Air Lines announced a $200 monthly health insurance surcharge for unvaccinated employees, 20% of Delta’s unvaccinated employees have already gotten the jab, Dr. Henry Ting, Delta’s chief health officer, said in an Infectious Disease Society of America briefing Thursday. “I think [that’s] a huge number in terms of shifting that group that’s most reluctant,” he said. (Stieg, 9/9)

Reuters: Moderna Developing Single-Dose Booster Shot For Covid And Flu
Moderna said on Thursday it is developing a single vaccine that combines a booster dose against Covid-19 with its experimental flu shot. The company hopes to eventually add vaccines it is working on for respiratory syncytial virus (RSV) and other respiratory diseases as an annual shot. "We believe this is a very large opportunity that is ahead of us, if we could bring to market a high efficacy pan-respiratory annual booster," Moderna Chief Executive Officer Stéphane Bancel said during a presentation to update investors on its drugs in development. (9/9)

Las Cruces Sun-News: Ivermectin Suspected Cause Of Fatal Poisoning In New Mexico
New Mexico's acting Health Secretary came down hard Wednesday on unfounded claims that the drug Ivermectin is a suitable treatment for COVID-19 disease. During a weekly update on the state's COVID-19 cases and response, state Human Services Secretary Dr. David Scrase, temporarily heading the state health department as well, said clinicians were investigating what was likely the state's first fatal case of an individual dosing themselves with the drug, while a suspected second case was in critical condition. “I’d like people to know, if they’re out there taking it, it can kill them," Scrase said. (D'Amassa, 9/9)

AP: NFL Opens To Full Stadiums As COVID-19 Surges
Tom Brady calmly ran out from a smoke-filled tunnel, leading the defending Super Bowl champion Buccaneers onto the field Thursday night against the Dallas Cowboys in front of a full stadium for the first time since COVID-19 upended the world and changed the way sports were viewed. The NFL kicked off its biggest season — teams are playing a 17-game schedule — with no capacity limitations as the league follows the NBA, NHL, MLB, NCAA and others in opening its doors to soldout stadiums. (Maaddi, 9/10)

The New York Times: When Was The First U.S. Covid Death? CDC Investigates 4 Early Cases 
Late last year, the federal government’s chief statistician on death received word about a tantalizing discovery: Someone had died from Covid-19 in January 2020, a death certificate said, a revelation that would have sped up the timeline of the virus’s spread in the United States by several weeks. That death was ultimately not what it seemed. The person who certified it had meant June 2020, not January. But that blip on the radar screen of Robert Anderson, the chief of mortality statistics at a branch of the Centers for Disease Control and Prevention, helped to kick off a quiet, yearlong campaign at the agency to check and recheck the country’s first suspected Covid-related deaths in the uncertain days of early 2020. (Mueller, 9/9)

Stat: Biogen Admits Aduhelm Launch ‘Slower Than We Anticipated’
Biogen CEO Michel Vounatsos admitted Thursday that the launch of Aduhelm, the company’s intensely scrutinized treatment for Alzheimer’s disease, has been “slower than we anticipated,” which he blamed in part on “confusion, misinformation, and controversy” about whether the drug works and how it was approved. Only about 50 centers around the country have administered at least one dose of Aduhelm, which won Food and Drug Administration approval on June 7, Biogen said at an investor conference sponsored by the investment bank Morgan Stanley. That has led Biogen to revisit its “already very low sales target” for 2021, Vounatsos said. (Garde and Feuerstein, 9/9)

AP: Endo Latest Company To Settle With New York Over Opioids
The state of New York and two large counties agreed Thursday a $50 million deal to end their lawsuits with drugmaker Endo International, in the latest of a progression of settlements of government claims over the opioid addiction and overdose crisis. Under the deal announced Thursday night, the Dublin-based drugmaker and its subsidiary Par are to pay $22.3 million to the state attorney general’s office and $13.85 million to both Suffolk and Nassau counties. (9/10)

Stat: For First Time, The FDA Warns A Researcher For Failing To Report Trial Results
In a little noticed warning, the Food and Drug Administration threatened to fine the principal investigator of a clinical trial for failing to submit results as required by federal law, marking the first time the agency has widened its list of targets that could face penalties for such a violation. Until now, the regulator had warned two different drug makers for failing to post study results to a federal database, ClinicalTrials.gov. Those moves came as a belated response to years of complaints that too many drug makers and universities do not follow requirements for reporting results, an issue that has riled countless researchers and transparency advocates. (Silverman, 9/9)

Stat: Early Data Suggest Hemophilia Drug Could Contend With Gene Therapy
Centessa, a biotech company that raised more than $300 million in an IPO earlier this year, has an early-stage treatment for hemophilia that might compete with the gene therapies nearing the market. The company’s drug, a monthly treatment injected under the skin, significantly reduced the rate of bleeding for patients with hemophilia A and B in a small study, Centessa said Thursday. In the trial, which enrolled just 23 people and was not placebo-controlled, the highest dose of Centessa’s drug led to an 88% reduction in annualized bleeding rate compared to baseline after six months. (Garde, 9/9)

Genomeweb: Amazon Investment Helps Mammoth Biosciences Reach $195M
CRISPR technology startup Mammoth Biosciences said on Thursday that it has raised a combined $195 million through Series C and Series D financing rounds, making it a so-called unicorn company — startups that are valued at more than $1 billion. The financing included a $45 million Series C round, which was completed in late 2020, and was led by Redmile Group and Foresite Capital. That round also included participation from previous investors, as well as Amazon. The financing also included a $150 million Series D round, which was led by Redmile Group, with participation from Foresite Capital, Senator Investment Group, Sixth Street, Greenspring Associates, Mayfield, Decheng Capital, NFX, and Plum Alley. (9/9)

NBC News: The U.S. Just Had Its Hottest Summer On Record
The United States had its hottest summer on record this year, narrowly edging out the previous milestone that was set 85 years ago during the Dust Bowl. The National Oceanic and Atmospheric Administration announced Thursday that the average temperature this summer for the contiguous U.S. was 74 degrees Fahrenheit, or 2.6 degrees warmer than the long-term average. The heat record caps off a season full of extremes, with parts of the country experiencing persistent drought, wildfires, record-breaking heat waves, hurricanes and other extreme weather exacerbated by climate change. (Chow, 9/9)

NPR: An Anti-Vaccine Book Tops Amazon's COVID Search Results. Lawmakers Call Foul
Amazon is under pressure from Democrats in Congress over how its algorithms promote hoax COVID-19 cures, including the livestock dewormer ivermectin, as well as anti-vaccination claims and other medical misinformation. Rep. Adam Schiff of California and Sen. Elizabeth Warren of Massachusetts sent letters this week to CEO Andy Jassy pressing for information on Amazon's misinformation policies and what the company is doing to stop its systems from recommending books and other products linked to falsehoods about the pandemic and vaccines. (Bond, 9/9)

The New York Times: Three-Minute Work Exercise Breaks Counter The Ill Effects Of Sitting 
Sitting for hours at a desk can play havoc with our metabolic health, contributing over time to high blood sugar and high cholesterol, even in people who otherwise seem mostly healthy. But a practical though small new study shows that standing up and moving every 30 minutes for about three minutes may lessen the health impacts of over-sitting. The study found that climbing several flights of stairs, bopping through some jumping jacks or squats or even taking as few as 15 steps during these mini-breaks improved aspects of blood sugar control among office workers, without noticeably interrupting their work flow. (Reynolds, 9/8)

The Washington Post: Stillbirths Double In Mississippi Amid Coronavirus Pandemic 
Mississippi has recorded 72 fetal deaths in unvaccinated pregnant women infected with the coronavirus, state health officials announced Wednesday, sounding the alarm on the virus’s danger in pregnancy. Speaking during a news conference, Mississippi State Health Officer Thomas Dobbs said those deaths had occurred since the start of the pandemic. The number, which includes only deaths that occurred past 20 weeks of gestation, “is twice the background rate of what would be expected,” he said. (Shammas, 9/9)

AP: California May Require Menstrual Products In Public Schools
California public schools and colleges would have to stock their restrooms with free menstrual products under legislation sent Thursday to Gov. Gavin Newsom as women’s rights advocates push nationwide for affordable access to pads, tampons and other items. The bill by Democratic Assemblywoman Cristina Garcia builds on her 2017 law requiring low-income schools in disadvantaged areas to provide students with free menstrual products. (Thompson, 9/9)

CNBC: Covid: U.S. Is The World’s Largest Donor Of Vaccines, Data Shows
The U.S. is the largest donor of Covid-19 vaccines globally — way ahead of other major economies such as China, Japan and the U.K., according to public data compiled by UNICEF. UNICEF is a United Nations agency responsible for the protection and development of children. It also manages Covid vaccine supply for the COVAX initiative, which aims to share doses with lower-income countries. (Lee, 9/9)

Bloomberg: Pandemic Risks Worsening On Africa Variants, Scientists Say 
The proliferation of Covid-19 variants in Africa, partly attributed to the low rates of vaccination on the continent, could lead to vaccine-evading mutations that complicate attempts to end the pandemic, a group of 112 African and 25 international organizations said. A study of genomes from 33 African nations and two “overseas territories,” published in the journal Science on Thursday, tracks the evolution of the pandemic across the continent and the emergence of a number of so-called Variants of Concern and Variants of Interest. One of those, beta, spread around the globe earlier this year and rendered some vaccines partially ineffective. (Sguazzin, 9/9)

CNN: World Suicide Prevention Day: How To Help In 2021
More than 700,000 people die by suicide each year, according to the World Health Organization. Translated: Every 40 seconds, someone in the world takes their own life. That's a sobering statistic to ponder today, on 2021's World Suicide Prevention Day. Suicide rates have been climbing for years in some parts of the world. In the United States alone, suicide rates have increased by 35% between 1999 and 2018. The US Centers for Disease Control and Prevention calls suicide a "growing public health problem." (LaMotte, 9/10)