First Edition: November 1, 2023

KFF Health News: Gubernatorial Candidates Quarrel Over Glory For Winning Opioid Settlements
Opioid settlement cash is not inherently political. It’s not the result of a law passed by Congress nor an edit to the state budget. It’s not taxpayer money. Rather, it’s coming from health care companies that were sued for fueling the opioid crisis with prescription painkillers. But like most dollars meant to address public health crises, settlement cash has nonetheless turned into a political issue. (Pattani, 11/1)

KFF Health News: Medical School On Cherokee Reservation Will Soon Send Doctors To Tribal, Rural Areas
Ashton Glover Gatewood decided to give medical school a second try after learning about a new campus designed for Indigenous students like herself. Gatewood is now set to be part of the first graduating class at Oklahoma State University’s College of Osteopathic Medicine at the Cherokee Nation. Leaders say the physician training program is the only one on a Native American reservation and affiliated with a tribal government. (Zionts, 11/1)

CNN: US Infant Mortality Rate Rises For First Time In More Than 20 Years
“We live in a country with significant resources, so the infant mortality rate and the increase are shockingly high,” wrote Dr. Sandy Chung, the president of the American Academy of Pediatrics, in an email to CNN. “As pediatricians who help children grow into healthy adults, any death of any child is one too many.  The infant mortality rate in this country in unacceptable.” (Viswanathan, 11/1)

AP: Maryland Man Who Received Second Pig Heart Transplant Dies, Hospital Says
The second person to receive a transplanted heart from a pig has died, nearly six weeks after the highly experimental surgery, his Maryland doctors announced Tuesday. Lawrence Faucette, 58, was dying from heart failure and ineligible for a traditional heart transplant when he received the genetically modified pig heart on Sept. 20. According to the University of Maryland School of Medicine, the heart had seemed healthy for the first month but began showing signs of rejection in recent days. Faucette died Monday. (Neergaard, 10/31)

The New York Times: Second Maryland Man To Receive An Altered Pig’s Heart Has Died
Lawrence Faucette, of Frederick, Md., was the second patient at the medical center to have had an ailing heart replaced with one from a pig that had been genetically modified so its organs would be more compatible with a human recipient and would not be rejected by the human immune system. The first patient, 57-year-old David Bennett, died last year, two months after his transplant. He had developed multiple complications, and traces of a virus that infects pigs were found in his new heart. (Caryn Rabin, 10/31)

Modern Healthcare: CDC Launches Healthcare Worker Burnout Initiative
The Centers for Disease Control and Prevention is launching an effort to help hospitals address workforce burnout and support the mental wellness of their employees. Led by the CDC’s National Institute for Occupational Safety and Health and the Dr. Lorna Breen Heroes Foundation, the initiative includes resources for hospitals to identify areas for improvement in employee well-being and training for frontline leaders to help foster a better work-life balance among staff. (Devereaux, 10/31)

Stat: CDC Asks Health Care Leaders To Step Up In Reducing Burnout
Often, workplace conversations about burnout put the onus on the individual to take care of their mental health while ignoring management’s role in solving the problem. A new anti-burnout campaign from the Centers for Disease Control and National Institute for Occupational Safety and Health avoids this typical — and often frustrating — tactic, instead imploring leaders to better support health care workers. (Trang, 10/31)

Politico: ‘Fundamentally Flawed’: VA Providers Bemoan New Electronic Health Records System
It’s been six months since the VA paused its rollout of a new electronic health records system but the physicians using it are still filing complaints and raising concerns about patient safety, according to internal messages obtained by POLITICO. Messages this month from clinicians at Mann-Grandstaff, a Veterans Affairs facility in Spokane, Wash., show deep frustration with the software from Oracle Cerner, the electronic health records vendor, stemming from outages and errors that prevent staff from filling prescriptions and referring patients to other providers. The messages also show providers struggling to access key patient data needed for patient safety. (Leonard, 10/31)

The New York Times: Panel Tells F.D.A. That CRISPR Sickle Cell Cure Is Safe Enough For Patients
A panel of experts said on Tuesday that a groundbreaking treatment for sickle cell disease was safe enough for clinical use, setting the stage for likely federal approval by Dec. 8 of a powerful potential cure for an illness that afflicts more than 100,000 Americans. The Food and Drug Administration had previously found that the treatment, known as exa-cel and jointly developed by Vertex Pharmaceuticals of Boston and CRISPR Therapeutics of Switzerland, was effective. The panel’s conclusion on Tuesday about exa-cel’s safety sends it to the F.D.A. for a decision on greenlighting it for broad patient use. (Kolata, 10/31)

Reuters: FDA Panel Says Vertex/CRISPR To Assess Safety Risks Of Gene Therapy In Follow-Up Study
A panel of advisers to the U.S. health regulator said on Tuesday Vertex Pharmaceuticals and CRISPR Therapeutics could assess potential safety risks of their sickle cell disease gene therapy after approval. ... The panel members said the 15-year follow up will help generate data from real-time monitoring of the therapy, which uses the new gene editing CRISPR technology. Staff reviewers to the U.S. Food and Drug Administration said the new type of technology raised concerns about the "off target", or unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about the therapy's efficacy. (10/31)

The Boston Globe: Patients With Sickle Cell Disease Urge FDA To Greenlight Landmark Gene-Editing Treatment
About a dozen people who have sickle cell disease or relatives with the debilitating blood disorder implored the Food and Drug Administration on Tuesday to approve a revolutionary gene editing treatment that those who received it in a clinical trial said transformed their lives. ...The FDA sought feedback about the scientific methods that Vertex and CRISPR used to evaluate the risk of inadvertently changing patients’ DNA beyond the targeted disease — so-called off-target editing. (Saltzman and Weisman, 10/30)

Reuters: U.S. FDA Approves Amgen's Biosimilar Version Of J&J's Psoriasis Drug
The U.S. Food and Drug Administration on Tuesday approved Amgen's (AMGN.O) biosimilar version of Johnson & Johnson's (JNJ.N) blockbuster psoriasis treatment, Stelara, for multiple inflammatory diseases. Despite the FDA approval, Amgen's treatment is expected to be launched in 2025 as part of a legal settlement between the two companies earlier this year to delay the entry of the therapy. (10/31)

Reuters: Optum, Express Scripts Want Opioid Special Master Out After Reply-All Email Mishap
Pharmacy benefit managers OptumRx and Express Scripts have asked a federal appeals court to disqualify a long-serving special master in national opioid litigation from working on any cases against them, after he accidentally hit "reply all" on an email that they say revealed him to biased. In a petition filed Monday with the 6th U.S. Circuit Court of Appeals, the companies said the August email, in which Special Master David Cohen wrote that pharmacy benefit managers (PBMs) "knew a lot" about illicit opioid prescriptions, created an appearance of impartiality that disqualified him. (Pierson, 10/31)

Politico: Reed: Tuberville Military Holds May Have Contributed To Marine Commandant’s Hospitalization
A top Senate Democrat said that the Marine Corps commandant’s recent medical emergency may be due in part to the fallout from Sen. Tommy Tuberville’s hold on top military promotions, which has forced several top officers to hold down multiple jobs. Senate Armed Services Chair Jack Reed (D-R.I.) leveled the accusation a day after the service disclosed that Gen. Eric Smith, a member of the Joint Chiefs of Staff, was hospitalized on Sunday. There was no immediate word of when Smith would be released or return to work. (Gould and O'Brien, 10/31)

The Hill: Sen. Tillis Tests Positive For COVID
Sen. Thom Tillis (R-N.C.) said Tuesday he tested positive for COVID-19 and would miss votes this week in the Senate. His office confirmed to The Hill he plans to return to Washington next week. (Fortinsky, 10/31)

CNN: Millions Have Used The 988 Mental Health Crisis Line, But Most Say They Wouldn’t Turn To It Again
The 988 Suicide and Crisis Lifeline has received millions of calls, texts and online messages since its launch in the summer of 2022, but a new study suggests that the mental health resource is far from reaching its full potential. People with severe psychological distress were more likely than others to have heard of 988 and to have used the lifeline, according to research published Tuesday in JAMA Network Open. But overall, only a quarter of people said they would be very likely turn to 988 in the future if they or a loved one were experiencing a mental health crisis or suicidality – and less than a third of people with severe psychological distress who had already tried the lifeline were very likely to use it again. (McPhillips, 10/31)

The Boston Globe: Involuntary Commitments Can Be A Vital Lifeline For Mental Health, But Patients’ Rights Must Be Considered
Amid revelations that an Army reservist was sent to a mental health hospital in New York against his will a few months before committing a mass shooting in Maine last week, clinicians Tuesday said an involuntary commitment can be a lifeline to treatment for a patient in danger of hurting themselves or other people. (Hilliard, 10/31)

NPR: U.S. Gun Violence Death Rate Is Higher Than Much Of The World
The U.S. has the 28th-highest rate of deaths from gun violence in the world: 4.31 deaths per 100,000 people in 2021. That was more than seven times as high as the rate in Canada, which had 0.57 deaths per 100,000 people — and about 340 times higher than in the United Kingdom, which had 0.013 deaths per 100,000. The numbers come from a massive database maintained by the University of Washington's Institute for Health Metrics and Evaluation, which tracks lives lost in every country, in every year, by every possible cause of death. (Aizenman, 10/31)

Axios Portland: Why Oregon's Law To Make Daylight Saving Time Permanent Isn't In Effect 
It's that time of year again. Clocks will need to be reset this weekend, falling back an hour at 2am Sunday. The time disruption affects our mental and physical health, fueling an ongoing debate about whether to stay year-round on daylight saving time, aka permanent summer time. (Harris, 10/30)

The Washington Post: Why Are People Afraid Of Clowns? A New Study Explains The Fear
Clowns can be unpredictable, inscrutable and a little weird. Those are just a few of the reasons why some people develop coulrophobia, or fear of clowns. (Amenabar, 10/30)

The New York Times: Hearing Aids Are More Affordable, And Perhaps More Needed, Than Ever
A year ago, the Food and Drug Administration announced new regulations allowing the sale of over-the-counter hearing aids and setting standards for their safety and effectiveness. That step — which was supposed to take three years but required five — portended cheaper, high-quality hearing aids that people with mild to moderate hearing loss could buy online or at local pharmacies and big stores. So how’s it going? It’s a mixed picture. (Span, 10/30)

The Hill: Children’s Hospitals Prepare For Surge In Admissions Amid Shortage Of RSV Drug
A supply shortage means a drug that can prevent respiratory syncytial virus (RSV) in infants won’t have a major immediate impact, children’s hospitals said, and they are preparing for a surge in admissions this respiratory disease season. “Widespread access [to the new antibody drug] will take time across many sectors of the pediatric population and won’t have as great an impact on volumes this immediate respiratory season,” the Children’s Hospital Association said in a statement. (Weixel, 10/31)

The Washington Post: Lung Cancer Rate Flips, Now More Common In Women Than Men Under 55
Although the overall lung cancer incidence rate has declined in recent years, the researchers found that the decline has been greater among men than women (down 44 percent vs. 20 percent for 50- to 54-year-olds, for instance). That has pushed the incidence rate higher among women than men and flipped the historical pattern of more lung cancer cases among middle-aged and younger men than women. (Searing, 10/31)

CIDRAP: Global COVID Vaccination Saved 2.4 Million Lives In First 8 Months, Study Estimates
The COVID-19 vaccination campaign in 141 countries averted 2.4 million excess deaths by August 2021 and would have saved another 670,000 more lives had vaccines been distributed equitably, estimates a working paper from University of Southern California (USC) and Brown University researchers. (Van Beusekom, 10/31)

CIDRAP: COVID Vaccines Not Linked To Miscarriages
A new study published in Human Reproduction shows no evidence that COVID-19 vaccination in either male or female partners is linked to early or late miscarriages and that maternal vaccination shortly before conception has no impact on early (less than 8 weeks) miscarriage rates. The study was based on outcomes seen in the Boston University School of Public Health’s Pregnancy Study Online (PRESTO), an ongoing study that follows participants from preconception through 6 months after delivery. The present study included 1,815 women from the United States and Canada who were followed from December 2020 through November 2022. The women were ages 21 to 45 years and were trying to conceive without the use of fertility treatment at enrollment. (Soucheray, 10/31)

CIDRAP: Paxlovid Shown Not Effective Against Long COVID In Veterans
A new study in the Annals of Internal Medicine of US veterans prescribed nirmatrelvir–ritonavir (Paxlovid) during COVID-19 infections shows no difference in long-COVID rates among groups who took the antivirals and those who did not. The study was based on 191,057 veterans with a first positive SARS-CoV-2 test result during January through July 2022. Among that group, 9,593 nonhospitalized patients were treated with Paxlovid, and outcomes were compared among their matched untreated cohorts for 31 post-COVID conditions (PCCs). (Soucheray, 10/31)

CIDRAP: Study Raises Questions About Efficacy Of Antibiotics For Serious Childhood Infections
A review and analysis of data from previously published studies found high levels of resistance to the antibiotics commonly used for empiric treatment of sepsis and meningitis in babies and children in the Asia-Pacific region, researchers reported today in The Lancet Regional Health–Southeast Asia. (Dall, 10/31)

Reuters: GSK Lifts Annual Forecasts On Strong Launch Of RSV Vaccine
GSK (GSK.L) on Wednesday raised its full-year profit and sales forecasts for a second time, after better-than-expected quarterly sales of its newly-launched respiratory syncytial virus (RSV) vaccine. (Mathews, 11/1)

AP: A Continuing Decline In Sales Of COVID-19 Products Clips Revenue At Pfizer
Pfizer lost more than $2 billion in the third quarter as an expected COVID-19 product sales decline clipped revenue. Sales of the drugmaker’s COVID treatment Paxlovid and the vaccine Comirnaty slid 97% and 70%, respectively, as Pfizer, like its competitors, switched to selling on the commercial market instead of to governments. (Murphy, 10/31)

Reuters: AstraZeneca To Invest $245 Mln In Cellectis To Boost Gene Therapy Prospects
AstraZeneca (AZN.L) said on Wednesday it would invest $245 million in French biotechnology company Cellectis (ALCLS.PA) in a deal aimed at speeding up the development of therapeutics in areas including oncology, immunology and rare diseases. Cellectis' gene-editing technology and manufacturing capabilities to design novel cell and gene therapy products will help strengthen AstraZeneca's growing offering in the space, it said. (11/1)

Modern Healthcare: IKS Health Acquires AQuity For $200M
IKS Health, a clinical documentation, coding and revenue tech company, acquired AQuity Solutions for $200 million, the companies said Tuesday. While IKS Health has primarily focused on products for the ambulatory market, AQuity has offered similar solutions in acute care settings. The combined company will have revenue of $330 million and employ 14,000 people. (Perna, 10/31)

Modern Healthcare: Olive AI Sells Remaining Assets To Waystar, Humata Health
Olive AI, a company that was once a ‘unicorn’ and valued at $4 billion, has sold its remaining assets and is winding down operations. The company, which developed technology to help providers and insurers automate the revenue cycle, sold its patient access software product to Waystar and its prior authorization business to Humata Health, Olive said Tuesday in a post on its website. (Perna, 10/31)

Stat: Eli Lilly To Pay $200M For Beam’s Stake In Gene-Editing Firm Verve
Eli Lilly said Tuesday that it will pay $200 million to gene-editing firm Beam Therapeutics for Beam’s stake in Verve Therapeutics, another gene-editing company focused on treatments for heart disease. (Herper, 10/31)

Bloomberg: Bayer Ordered By California Jury To Pay $332 Million In Roundup Cancer Trial 
Bayer AG’s Monsanto unit was ordered by a California jury to pay $332 million to a former land surveyor who blamed his cancer on his use of the company’s controversial Roundup weedkiller – the third trial loss this month for the company. Jurors in state court in San Diego on Tuesday awarded Michael Dennis, 57, a total of $7 million in actual damages and $325 million in punitive damages over his claims 35 years of using Roundup on his lawns and gardens caused his non-Hodgkin’s lymphoma. (Feeley and Loh, 10/31)

Modern Healthcare: Calibrate CEO Isabelle Kenyon Steps Down
Isabelle Kenyon, founder and CEO at weight loss telehealth company Calibrate, is stepping down as CEO, she said Tuesday in a post on the user-generated publishing website Medium. Kenyon said she will continue to work with Calibrate, efforts that will include "evangelizing our mission, vision, and values" and helping increase access to the company's weight loss programs.  (Turner, 10/31)

AP: Missouri Appeals Court Rules Against Ballot Summary Language That Described 'Dangerous' Abortions
A Missouri appeals court ruled Tuesday against Republican-written summaries of abortion-rights ballot measures that described several proposed amendments as allowing “dangerous and unregulated abortions until live birth. ”A three-judge panel of the Western District Court of Appeals found the summaries written by Republican Secretary of State Jay Ashcroft, who is running for governor in 2024, are politically partisan. (Ballentine, 10/31)

Politico: Haaland Announces Funding For Colorado Mine Cleanup
Interior Secretary Deb Haaland on Tuesday rolled out $10 million in federal funds to boost mine cleanup efforts in Colorado, a portion of the $16 billion in funds Congress designated for legacy pollution cleanup efforts nationwide. ... “People spend years dealing with serious environmental and health risks caused by these sites,” Haaland said. “But I believe that we have the resources to end this cycle. Together we can make these smart investments and build a cleaner and more just future for our children and our grandchildren.” (Yachnin, 10/31)

Fresno Bee: University Of California Paid 114 Doctors Over $1 Million Last Year. How Many Were Women? 
The University of California’s health system paid 113 medical professors at least $1 million in total pay last year. Only 12 of those high-earning health professionals were women, according to a Sacramento Bee analysis of 2022 payroll data from the UC Office of the President. (Miller and Reese, 10/31)

The 19th: Pregnant Farmworkers Get Time Off To Prevent Pesticide Exposure — But Many Don't Know It Exists
For over two decades, a growing body of research has found several associations between pesticides and issues in early childhood development, specifically for children born in farmworking communities. What the research has found is that prenatal exposure to pesticides has been linked with neurodevelopmental issues like decreased cognition and lower IQ in childhood and an increase in ADHD and autism, said Carly Hyland, an epidemiologist at the University of California, Berkeley who has worked on a study of 600 pregnant farmworkers in California’s Salinas Valley, and has followed the development of their children since the 1990s. (Kutz, 10/31)

CBS News: "Hopeless And Frustrated": Idaho's Abortion Ban Is Driving OB/GYNs Out Of The State
Idaho's restrictive abortion laws are fueling an exodus of OB/GYNs, with more than half of those who specialize in high-risk pregnancies expected to leave the state by the end of the year. Doctors CBS News spoke with said treating non-viable pregnancies, in which the fetus is not expected to survive, puts them and their patients in what they call an impossible position. (Diaz, Kegu, and Novak, 10/31)

CBS News: Treating Prostate Cancer Just Got Easier In The Twin Cities
November is men's cancer awareness month, and there's some news many men are not aware of — screening for prostate cancer is now as simple as getting a blood test. And for those who do end up having cancer, treating the condition can be easier than ever in the Twin Cities. ... High Intensity Focused Ultrasound — a HIFU. It's a probe that heats and treats only the part of the prostate with cancer and the surrounding area. WCCO got a peak of the only machine in the cities - at Methodist Hospital. (Littlefield, 10/31)