First Edition: Wednesday, Oct. 9, 2024

KFF Health News: Poppy Seed Brew Triggers Morphine Overdose, Drawing Attention Of Lawmakers
It sounds like a joke: poppy seeds infused with opioids. Indeed, it was a plotline on the sitcom Seinfeld. But for some it has been a tragedy. People have died after drinking tea brewed from unwashed poppy seeds. And after eating lemon poppy seed bread or an everything bagel, mothers reportedly have been separated from newborns because the women failed drug tests. Poppy seeds come from the plant that produces opium and from which narcotics such as morphine and codeine are derived. (Hilzenrath, 10/9)

KFF Health News: Employers Haven’t A Clue How Their Drug Benefits Are Managed
Most employers have little idea what the pharmacy benefit managers they hire do with the money they exchange for the medications used by their employees, according to a KFF survey released Wednesday morning. In KFF’s latest employer health benefits survey, company officials were asked how much of the rebates collected from drugmakers by pharmacy benefit managers, or PBMs, is returned to them. (Allen, 10/9)

KFF Health News: 'An Arm and a Leg' Podcast: ‘Baby Steps’ In The Fight Against Facility Fees
An extra $99 fee on top of a copay for a checkup didn’t sit right with a listener. Turns out, state legislators across the country aren’t buying it either. (10/9)

KFF Health News: Asian Health Center Tries Unconventional Approach To Counseling
In her first months as a community health worker, Jee Hyo Kim helped violent crime survivors access supportive services and resources. When a client with post-traumatic stress disorder sought a therapist, she linked him to one that fit his needs. She helped clients afraid to leave their homes obtain food delivery vouchers. As one client described her, Kim was a “connector.” Then, Kim learned to go further. (10/9)

KFF Health News: Listen To The Latest 'KFF Health News Minute'
“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week. (10/8)

Reuters: GSK RSV Shot 43% Effective Against Severe Disease In Third Year
GSK said on Tuesday that its Arexvy respiratory syncytial virus vaccine was 43.3% effective in preventing severe illness in its third season after patients received the shot. That compares with 94.1% effectiveness in preventing severe RSV in the first season and 64.2% a year later, according to data from GSK's Phase 3 clinical trial. The trial initially enrolled about 25,000 volunteers in 17 countries. Arexvy is one of three RSV vaccines approved for use, alongside shots made by Pfizer and Moderna, with GSK's shot so far dominating the market. (10/8)

Reuters: GSK, Pfizer RSV Vaccine Sales Fall In US As Millions Fewer People Line Up
U.S. sales of RSV vaccines from GSK (GSK.L) and Pfizer (PFE.N) are down significantly after regulators narrowed the targeted age group and said it was a once-in-a-lifetime shot for now, excluding millions of people who got one last year. Some independent pharmacists said demand during the autumn vaccination season for respiratory syncytial virus shots has fallen as much as two-thirds from a year ago. (Erman, 10/9)

CIDRAP: FDA Authorizes Sale Of First Home COVID/Flu Combo Test Outside Of Emergency Use
As the country heads into the respiratory illness season, the US Food and Drug Administration (FDA) announced yesterday its marketing authorization of the first over-the-counter (OTC) rapid-antigen COVID-19/flu combination test outside of emergency use authorization. The Healgen Rapid Check COVID-19/Flu A&B Antigen Test takes 15 minutes to detect proteins from both COVID-19 and influenza A and B in nasal swabs. (Van Beusekom, 10/8)

Reuters: Pfizer, BioNTech Win Bid To Invalidate CureVac's UK COVID Vaccine Patents
Pfizer (PFE.N) and its German partner BioNTech (22UAy.DE) on Tuesday won their attempt to invalidate two of rival CureVac's (5CV.DE) patents at London's High Court. Pfizer and BioNTech had filed their lawsuit in September 2022 over patents relating to messenger RNA (mRNA) technology, which underpins Pfizer and BioNTech's COVID-19 vaccine. Tuesday's ruling relates to the London leg of Pfizer, BioNTech and CureVac's global legal battle, which also involves litigation in the United States and Germany. (10/8)

NPR: LGBTQ+ Women Face High Rates Of Trauma, Other Mental Health Issues, Report Finds
A leading national survey finds that 22% of LGBTQ+ women respondents have attempted suicide, and 66% reported seeking treatment for trauma. “The trauma burden in this community is enormous,” said Jaime Grant, one of the researchers who conducted the survey. (Roldan, 10/8)

The New York Times: 3% Of American High Schoolers Identify As Transgender, First National Survey Finds
About 3.3 percent of high school students identify as transgender and another 2.2 percent are questioning their gender identity, according to the first nationally representative survey on these groups, published by the Centers for Disease Control and Prevention on Tuesday. Transgender and gender-questioning teenagers reported alarmingly higher rates of bullying at school, persistent sadness and suicidal thoughts and behaviors, according to the survey, which was carried out in 2023. (Ghorayshi, 10/8)

AP: Democrats Hope The Latest Court Rulings Restricting Abortion Energize Voters As Election Nears
Two court rulings this week have delivered major blows to reproductive rights in Texas and Georgia but, during a crucial time in the election cycle, Democrats are seizing on them in an attempt to energize voters who support abortion access. Advocates hope the rulings will serve as reminders about what’s at stake in a post-Roe America just weeks before a presidential election that has been partly defined by competing visions of abortion rights and the sometimes harrowing consequences for women living in states with abortion bans. (Fernando, 10/8)

The Hill: Audio Reveals Montana GOP Senate Candidate Comments On Abortion, Youth Voters
Montana GOP Senate nominee Tim Sheehy said young women are “single-issue voters” on abortion and young voters are “indoctrinated” to support liberal causes, according to audio of the candidate speaking at campaign events last year. ... These newly reported comments concern abortion, which has been a rallying issue for supporters of abortion rights and a potential vulnerability for Republicans following the 2022 overturning of Roe v. Wade. (Gans, 10/8)

The Hill: Donald Trump's Stance On Abortion Raises Questions For Evangelicals
Former President Trump’s softening stance on reproductive health has raised questions about his standing with white evangelical voters, a key part of his coalition dating back to 2016. Last week, the former president said he would veto a national abortion ban if elected, while his running mate, Sen. JD Vance (R-Ohio), said the GOP needed to regain voters’ trust on the issue. Former first lady Melania Trump went even further, emphatically voicing her support for abortion rights. (Manchester, 10/8)

The Wall Street Journal: Exclusive | Abortion Pill Maker Is Seeking To Expand Its Use To Miscarriage
The drugmaker responsible for bringing the controversial abortion pill to the U.S. is now pursuing a new use that could widen women’s access: treating miscarriages. Danco Laboratories is preparing scientific data and taking other steps to ask the Food and Drug Administration to approve use of the abortion pill regimen Mifeprex for management of miscarriages, according to people familiar with the matter. (Essley Whyte, 10/8)

Becker's Hospital Review: Baxter Resumes Some IV Shipments: 5 Updates
Baxter on Oct. 8 said it has resumed shipments of IV products to hospitals and dialysis patients after a temporary week-long hold and is inspecting finished goods to support current allocations. Baxter also said several of the manufacturer's global plants are ramping production to meet U.S. needs and expect to receive product from the sources throughout October. As hospitals across the U.S. confront an IV fluid shortage  following the aftermath of Hurricane Helene, there have been new reports of supply disruptions. (Murphy, 10/8)

Reuters: Fresenius Looking To Boost Output After Hurricane Damage At Rival Baxter
Germany's Fresenius (FREG.DE) said it was checking options to speed up the start of new production lines of medical equipment at a North Carolina facility to help mitigate potential shortages from hurricane damage to rival Baxter's (BAX.N) site in the same state. "We are working with the U.S. Food and Drug Administration’s Drug Shortage Staff, which is actively engaged with Baxter and other manufacturers" to assess whether and by how much capacity has to be increased, Fresenius said in a statement. (10/9)

The Washington Post: Florida Health-Care Workers Exhausted As Hurricane Milton Approaches
The storm shutters are up at Stephen Johnson’s house near the water in North Fort Myers, Fla. He has extra food and water for his 65-year-old mother and their two dogs and two cats. But Jones won’t be home when Hurricane Milton is expected to thunder ashore this week along the Gulf Coast. Instead, the paramedic — like thousands of health-care workers across Florida — intends to ride out the storm at work, then jump into action when the winds die down, the waters recede and people seek medical assistance. (Ovalle and Malhi, 10/8)

The New York Times: On Drug Prices, Harris Pushes For Deeper Cuts While Trump Offers Few Specifics
Insulin for $35 a month. A limit of $2,000 a year in out-of-pocket drug costs for older Americans. Billions of dollars in savings for Medicare resulting from drug negotiations. Whether these policies expand or, in the case of the negotiations, survive at all may be determined by the election in November. Vice President Kamala Harris, the Democratic nominee, has vowed to extend President Biden’s policies to more drugs and more Americans. (Abelson and Robbins, 10/8)

Politico: CBO Evaluates The Drug Pricing Policy Menu
A slate of popular policies commonly bandied about to help reduce drug costs would each cut average prices by only a handful of percentage points, according to a recent Congressional Budget Office report. But even small percentage savings could be consequential: By 2031, the retail drug market is slated to grow to more than $690 billion, according to the CBO. That includes both public and private buyers. (Lim and Gardner, 10/8)

The Hill: Pharmacies Sue FDA Over Ending Mounjaro, Zepbound Shortage
A trade organization representing compounding pharmacies that make unbranded versions of the weight loss drugs Mounjaro and Zepbound has filed a lawsuit against the Food and Drug Administration (FDA) for declaring an end to the shortage, effectively halting the sale of “copycat” versions of these drugs. On Oct. 2, the FDA announced that the nearly two-year-long shortage of tirzepatide, the active ingredient in Mounjaro and Zepbound, had ended. (Choi, 10/8)

Reuters: US FDA Declines To Approve Zealand's Drug For Low Blood Sugar In Infants
The U.S. health regulator has declined to approve Zealand Pharma's (ZELA.CO) drug to prevent and treat low blood sugar in children with a genetic disorder, the Danish biotech firm said on Tuesday, marking the second rejection for the treatment. The Food and Drug Administration (FDA) in its so-called "complete response letter" cited the timing of a third-party manufacturing facility reinspection for the decision, the company said. The letter, however, did not mention any concerns about the clinical data package or safety of the drug, dasiglucagon. (10/9)

Becker's Hospital Review: Feds Warn Of 'Double Extortion' Hackers Targeting Healthcare
Federal authorities are warning of a new ransomware gang that has already claimed at least one healthcare victim in the U.S. Trinity ransomware, which was first detected around May, uses tactics such as phishing emails, malicious websites and software vulnerabilities to hack organizations then employs "double extortion," according to an Oct. 4 notice from HHS' Office of Information Security and Health Sector Cybersecurity Coordination Center. (Bruce, 10/8)

Politico: Agreeing To Disagree On Safeguarding Health Info
Providers, health IT groups and reproductive health care advocates largely support a proposed HHS rule to make health data, including public health information, easier to share while protecting patient privacy. But they disagree on the specific wording needed to protect reproductive health care data. Background: The rule, proposed in July, would standardize how public health departments transmit data among each other and to the CDC via certified protocols. (Cirruzzo and Leonard, 10/8)

AP: Hot Days And Methamphetamine Are Now A Deadlier Mix
On just one sweltering day during the hottest June on record in Phoenix, a 38-year-old man collapsed under a freeway bridge and a 41-year-old woman was found slumped outside a business. Both had used methamphetamine before dying from an increasingly dangerous mix of soaring temperatures and stimulants. Meth is showing up more often as a factor in the deaths of people who died from heat-related causes in the U.S., according to an Associated Press analysis of data from the U.S. Centers for Disease Control and Prevention. (Snow and Wildeman, 10/9)

Newsweek: Your Toothbrush Is Teeming With Unknown Viruses, Say Microbiologists
In a new study published in Frontiers in Microbiomes, researchers from Northwestern University collected samples from 32 toothbrushes and 92 showerheads across the United States and found hundreds of different viruses on their surfaces, many of which had never been seen before. "We may think of our toothbrushes and showerheads in one way, but in another sense, they are a habitat for microbes, a place where microbial ecology happens," the study's lead author, Erica Hartmann, told Newsweek. "It's a microbial world; we just live in it." (Dewan, 10/9)

The Washington Post: Exoskeleton Helped Man Walk, But Maker Stopped Offering Repairs
An exoskeleton gave Michael Straight the ability to walk again after a horse racing accident left him a paraplegic. Over the course of 10 years, Straight walked more than a half-million steps while paralyzed, helping to pioneer a field. But in June, his machine stopped working, and the manufacturer refused to repair it. For the first time in a decade, Straight couldn’t walk. “It was like being paralyzed all over again,” he said. (Edwards, 10/8)

The New York Times: Her Face Was Unrecognizable After an Explosion. A Placenta Restored It.
In the aftermath of a propane explosion at her mother’s house in Savannah, Ga., in 2021, Ms. Townsend spent more than six weeks in an induced coma in a burn trauma unit. She had second- and third-degree burns over most of her body, and her face had become unrecognizable. Searching for a way to help her, surgeons turned to a rarely utilized tool: human placenta. They carefully applied a thin layer of the donated organ to her face, which Ms. Townsend said was “the best thing they could have done, ever.” She still has scars from grafts elsewhere on her body, but the 47-year-old’s face, she said, “looks exactly like it did before.” (Morgan, 10/8)

The Washington Post: 2 New Alzheimer’s Drugs May Help Early Stage Patients Manage The Disease
When Dennis Carr learned he had early Alzheimer’s disease, he immediately thought of his older brother who had died of the illness in 2023. “There was not much anyone could do,” Carr said of his brother’s long decline. “You could see him diminishing.” Today, Carr is trying a new treatment called Leqembi that has been shown to modestly slow the disease for people in the initial stages of Alzheimer’s. Carr knows it is not a cure but he wants to buy time — to be with his family, to work and to give scientists a chance to find more solutions. (McGinley, 10/8)

CIDRAP: Babesiosis Rates Rising Steadily In The US
Rates of babesiosis, a tickborne disease, increased by 9% per year in the United States from 2015 to 2022, according to a study today in Open Forum Infectious Diseases. The study also found 4 in 10 people with babesiosis were coinfected with another tickborne illness, including Lyme disease. ... The infection attacks the red blood cells, and though most people recover after flu-like symptoms, infection can be deadly in the elderly and immune compromised. (Soucheray, 10/8)

CIDRAP: Case Report: Live Oropouche Virus Found In Semen 16 Days After Symptom Onset
A study published yesterday in Emerging Infectious Diseases describes prolonged shedding of Oropouche virus RNA in a symptomatic traveler's whole blood, serum, and urine, while viral replication was detected in semen 16 days after infection, which the authors say suggests a risk of sexual transmission. Oropouche virus, an emerging zoonotic arbovirus, is spread mainly by biting midges and Culex quinquefasciatus mosquitoes. (Van Beusekom, 10/8)

The Wall Street Journal: Pfizer CEO’s Job Is At Risk. A Shot Of Discipline Could Help
When former executives team up with an activist investor to “help” a struggling company, it is often bad news for the current chief executive. That is one implication behind activist investor Starboard Value’s $1 billion stake and its push to make changes at Pfizer, which The Wall Street Journal reported has support from former Pfizer Chief Executive Ian Read and former Chief Financial Officer Frank D’Amelio. Another important takeaway is that investors are eager to see a more disciplined and focused development strategy from the company. (Wainer, 10/8)

Modern Healthcare: Teladoc COO Michael Waters To Depart At End Of 2024
Michael Waters, chief operating officer of Teladoc Health, will leave his position at the end of the year. Waters will exit effective Dec. 31 in connection with a change in the executive reporting structure, according to a Sept. 27 Securities and Exchange Commission filing. He has served as Teladoc's COO since July 2022. (Desilva, 10/8)

Reuters: WeightWatchers To Offer Compounded Version Of Novo Nordisk's Weight-Loss Drug
WeightWatchers said on Tuesday it would offer a compounded version of Novo Nordisk's popular obesity drug Wegovy as part of its weight-management programs, sending its shares nearly 47% higher to an over two-month closing high. Soaring demand for weight-loss drugs such as Wegovy and Eli Lilly's Zepbound, shown to help patients lose as much as 20% of weight on average, has led to shortages that allowed drug compounders to produce them under U.S. regulations. (10/8)

Modern Healthcare: 4 Nonprofit Health Systems Launch Longitude Health
Four large nonprofit health systems created a new company to use as a testing ground for boosting access to drugs, improved care coordination for Medicare Advantage patients and streamlined billing processes. Baylor Scott & White Health, Memorial Hermann Health System, Novant Health and Providence are the founding members of Longitude Health. Each health system has made an undisclosed financial commitment to fund Longitude, which is a Delaware-based holding company owned and managed by its founders. (Kacik, 10/8)

Modern Healthcare: Maven Raises Funding From StepStone Group, General Catalyst
Virtual reproductive and family care startup Maven Clinic has raised a $125 million Series F funding round, the company said Tuesday. Investment firm StepStone Group led the round with participation from existing investors including venture capital firms General Catalyst, Sequoia, Oak HC/FT, Icon Ventures and Lux Capital. (Turner, 10/8)

Modern Healthcare: Medicare Advantage Insurers Bank On Special Needs Plans In 2025
Investing in products for individuals with complex medical needs has emerged as a key tactic for health insurers endeavoring to revive Medicare Advantage margins. Leading insurance companies pulled back slightly from Medicare Advantage for the coming plan year amid financial strains but are continuing a big push into the market for Dual-Eligible Special Needs Plans, or D-SNPs, which cover people who are eligible for both Medicare and Medicaid, according to analyses of preliminary data about the 2025 Medicare Advantage marketplace. (Berryman, 10/9)

The Wall Street Journal: Massachusetts Alleges Steward Health’s Malpractice Insurer Leaves Doctors Exposed
Steward Health Care physicians could be exposed to malpractice lawsuits for years to come and plaintiffs may not be able to collect awards because a Panamanian insurer the bankrupt hospital operator owns will likely run out of money, Massachusetts officials said. TRACO International Group, which insures 1,400 physicians, is financially dependent on Steward and has little to no independent capital of its own, according to a court filing Monday by the Massachusetts attorney general and state health regulators. (Biswas, 10/8)

AP: States Sue TikTok For Harming Children's Mental, Physical Health
More than a dozen states and the District of Columbia filed lawsuits against TikTok on Tuesday, saying that the popular short-form video app is designed to be addictive to kids and harms their mental health. The lawsuits stem from a national investigation into TikTok, which was launched in March 2022 by a bipartisan coalition of attorneys general from many states, including New York, California, Kentucky and New Jersey. All of the complaints were filed in state courts. (Hadero and Ortutay, 10/8)