- KFF Health News Original Stories 2
- The Real Costs of the New Alzheimer’s Drug, Most of Which Will Fall to Taxpayers
- Repeating History: California County Plugs Budget Gap With Opioid Settlement Cash
From KFF Health News - Latest Stories:
KFF Health News Original Stories
The Real Costs of the New Alzheimer’s Drug, Most of Which Will Fall to Taxpayers
The annual cost of lecanemab treatment quadruples if the expense of brain scans to monitor for bleeds and other associated care is factored in. The full financial toll likely puts it beyond reach for low-income seniors at risk of Alzheimer’s, experts say. (Arthur Allen, 8/2)
Repeating History: California County Plugs Budget Gap With Opioid Settlement Cash
State attorneys general vowed that opioid settlement funds — unlike the tobacco settlement of the 1990s — would go toward tackling the underlying crisis. But in Mendocino County, officials have found a way to use some of its share to help fill a budget shortfall — a throwback to what agreement architects hoped to avoid. (Aneri Pattani, 8/2)
Summaries Of The News:
Indiana Clinics Halt Abortion Services, File Last-Ditch Appeal To State Ban
Indiana's law -- that's on pause again -- bans all surgical abortions at any point in the pregnancy, with limited exceptions for health risks for the mother or in cases or rape or incest. The state's six abortion clinics stopped offering services yesterday.
NPR:
Indiana's Abortion Ban Has Been Halted By Another Lawsuit
A near total ban on abortion in Indiana to go into effect Tuesday is on hold again after abortion providers filed another lawsuit in a last-ditch effort to halt it. (Smith, 8/2)
AP:
Indiana Abortion Clinics Stop Providing Abortions Ahead Of Near-Total Abortion Ban Taking Effect
Indiana’s six abortion clinics have stopped providing abortions ahead of the state’s near-total abortion ban officially taking effect and as a petition is pending before the state’s high court asking it to keep the ban on hold while legal action continues, clinic officials said Tuesday. Planned Parenthood’s four Indiana abortion clinics stopped performing abortions Monday in accordance with state guidance that providers received in July alerting them that on or around Tuesday abortion would become illegal in Indiana in clinic settings “with really very, very limited exceptions,” said Rebecca Gibron, CEO of the Planned Parenthood division that includes Indiana. (Callahan, 8/1)
Indiana Capital Chronicle:
Indiana Planned Parenthood Clinics Stop Providing Abortions, Although Ban Stays Paused
Despite hesitancy among health care providers — and confusion over whether Indiana’s near-total abortion ban would go back into effect Tuesday — the law will not be enforceable until the state Supreme Court certifies its June ruling. Indiana Supreme Court justices tossed out a wide-ranging preliminary injunction in late June when they largely upheld the state’s abortion ban on constitutional liberty grounds. But until the high court certifies its decision, an injunction remains in place — blocking the new law from taking effect. (Smith, 8/1)
More abortion news —
AP:
Idaho Health Care Providers Can Refer Patients For Abortions Out Of State, Federal Judge Rules
A federal judge has ruled that it would violate Idaho medical providers’ free speech rights to sanction them for referring patients to out-of-state abortion services, rejecting the state attorney general’s interpretation of Idaho’s abortion ban. Idaho’s law makes it illegal to perform or attempt to perform an abortion, a crime punishable by two to five years in prison. It also makes it unlawful for health care professionals to assist in the provision or attempted provision of one, with the penalty being the suspension or loss of their medical license. (Johnson and Komenda, 8/1)
Reuters:
US Appeals Court Reinstates Guam In-Person Abortion Counseling Law
A federal appeals court on Tuesday reinstated a law requiring that women in Guam meet with doctors in person before obtaining abortions, a restriction that has made terminating pregnancies in the U.S. territory difficult due to a lack of doctors. The San Francisco-based 9th U.S. Circuit Court of Appeals overturned a judge's 2021 ruling that blocked enforcement of the law, citing the U.S. Supreme Court's ruling last year overturning the 1973 Roe v. Wade decision that had established a national right to abortions. (Raymond, 8/1)
Bloomberg:
Abortion Pill Provider Buys From Indian Manufacturer With Bad Quality Record
With splashy marketing campaigns and major donors like the Bill & Melinda Gates Foundation, DKT International has become one of the world’s largest sellers of abortion pills, serving women from India to Mexico. The Washington DC-based nonprofit says it provides high-quality medicines, condoms and other reproductive health products at affordable prices. But almost one-fifth of the 30 million products DKT distributes annually for abortions and postpartum hemorrhage prevention come from an Indian company with a record of making substandard medicine. (Taggart and Pulla, 8/1)
Also —
AP:
Global AIDS Program Targeted In Abortion Battle Gets New Home In State Department Bureau
The State Department launched a new bureau Tuesday aimed at making the battle against global outbreaks a lasting priority of U.S. foreign policy, even as one of its key elements – a widely acclaimed HIV program – has become caught up in the political battle over abortion. The bureau is to include the 20-year-old initiative known as the President’s Emergency Program for AIDS Relief, or PEPFAR. ... Secretary of State Antony Blinken, in a ceremony for the new Bureau of Global Health Security and Diplomacy, made only a passing reference to the abortion fight threatening PEPFAR’s normally assured support from lawmakers, saying he hoped Congress approved the program for another five years, without amendments. (Knickmeyer, 8/1)
Access To Maternity Care In US Getting Worse, Especially For Black Women
Two new reports from March of Dimes and Milken Institute detail the deteriorating quality of care for pregnant women, which is particularly concerning as abortion access is cut off in many states.
Axios:
Giving Birth In America Continues To Get Deadlier
It's becoming ever more dangerous to give birth in America, especially for Black women, older women and those living in rural areas, according to a pair of new reports from March of Dimes and Milken Institute. The dismal U.S. maternal health statistics are usually a sidebar in the abortion wars, but many experts believe that increasing the number of births by further restricting access to abortion will only worsen the situation. (Owens, 8/2)
USA Today:
Maternity Care Deserts: March Of Dimes Report Shows Worsening Access
The number of women struggling to access to maternal care in the U.S. continues to grow, with nearly 7 million women affected by areas of no to low access, according to a new report released Tuesday by March of Dimes. The nonprofit organization's 2022 report shows 1,119 counties qualify as maternity care deserts, marking a 2% increase from the 2020 report or an additional 15,933 women who have no maternity care. (DeLetter, 8/1)
Atlanta Journal-Constitution:
Where You Live Matters For Maternity Care In Georgia
More than one in three Georgia counties where thousands of Georgia mothers give birth each year is a “maternal care desert,” according to a report released Tuesday by the March of Dimes. Partly as a result, the report found, 17% of those who gave birth received no or inadequate prenatal care. (Hart, 8/2)
Houston Chronicle:
Half Of Texas Counties Are Maternity Care Deserts, Report Says
Almost 47 percent of Texas counties are considered "maternity care deserts" compared to 32.6 percent in the U.S., according to a new report from the March of Dimes Perinatal Data Center. (Garcia, 8/1)
Pfizer Says Refreshed Covid Shots Could Be Authorized This Month
The drugmaker's CEO Albert Bourla revealed he thinks the FDA could authorize updated covid boosters by the end of the month during an investor call. Separately, CNN reports that vaccines for flu and RSV are being rolled out to major pharmacy chains ahead of the fall respiratory virus season.
NBC News:
Updated Covid Boosters Could Be Authorized By End Of Month, Pfizer Says
The Food and Drug Administration could authorize Pfizer's updated Covid boosters by the end of August, Pfizer CEO Albert Bourla said during an investor call Tuesday. The drugmaker asked the FDA in June to authorize an updated version of its Covid booster that is designed to target the XBB.1.5 subvariant, a coronavirus strain that began circulating widely last winter. Moderna made a similar request that same month. (Lovelace Jr., 8/1)
CNN:
Vaccines For Flu And RSV Now Available Ahead Of Fall Virus Season
With the fall respiratory virus season just around the corner, major US pharmacy chains have begun rolling out flu and RSV vaccine appointments. Walgreens is now offering both kinds of shots, the company said Tuesday. Anyone 3 or older can get a flu shot, and adults 60 and older are eligible for the RSV vaccine. Rite Aid also plans to announce availability of those vaccines soon, spokesperson Catherine Carter says. (Musa, 8/1)
Reuters:
Pfizer Considers Cost Cuts As Demand For COVID Products Falls
Pfizer on Tuesday said it will launch a cost-cutting program if its COVID-19 vaccine and antiviral treatment keep underperforming expectations in the coming months due to plunging demand. Pfizer said it anticipates more clarity on the future size of the COVID market later this year as infection rates rise in the autumn and the U.S. switches to a commercial market from government contracts for the vaccine. (Satija and Erman, 8/1)
More on the spread of covid —
ABC News:
Why Rising COVID Hospitalizations Should Not Necessarily Be A Cause For Concern
For the week ending July 22, hospitalizations rose 12% from the previous week from 7,165 to 8,035, according to data released Monday from the Centers for Disease Control and Prevention. While a double-digit percentage jump may seem scary, experts say these numbers are still among the lowest we have seen since the pandemic began and that there is no reason to panic just yet. (Kekatos and Benadjaoud, 8/1)
Houston Chronicle:
COVID Infections Rise In Houston For Fourth Summer In A Row, Threatening Vulnerable Residents
Infections are rising in Texas and Houston for the fourth summer in a row, with many hospitals reporting an uptick in admissions and wastewater data showing increasing viral load in all but five of the city’s 39 wastewater treatment plants. Texas Children’s Hospital also continues to see an elevated number of pediatric COVID patients. (Gill, 8/1)
CIDRAP:
Long-COVID Patients Have Altered Metabolite Levels 2 Years After Infection
Levels of metabolites were altered in long-COVID patients 2 years after infection, suggests a study published today in Scientific Reports. Metabolites are products of metabolism, or the process of changing food and drink into energy, that have cell-level roles, such as providing fuel, structure, or defense. (Van Beusekom, 8/1)
CIDRAP:
Overall Risk Of Pediatric ICU Stay, Death In COVID-19, MIS-C Low, Study Shows
A University College London–led team finds a very low risk of pediatric intensive care unit (PICU) admission and death from COVID-19 and multisystem inflammatory syndrome in children (MIS-C) during the first 2 years of the pandemic, with the highest risk among children with complex medical problems and neurodisabilities. The researchers conducted a population-level analysis of hospitalizations after COVID-19 infection in England among youth 0 to 17 years old from February 1, 2020, to January 31, 2022. They linked national hospital data with data on COVID-19 testing, vaccination, PICU admissions, and death. (Van Beusekom, 8/1)
Also —
CIDRAP:
Healthcare Workers' Depression Increased In Second Year Of Pandemic
A study today of 2,564 Czech healthcare workers finds that their prevalence of depression increased twice during the pandemic. The study is published in Scientific Reports. ... "This change was explained the most by increased stress, contact with COVID-19 patients, and experience of death due to COVID-19," wrote the authors, who employed a number of models to show how and why participants saw increased rates of depression. "Perceived stress has been consistently found to be a risk factor for depression in HCWs over the course of [the] COVID-19 pandemic." (Soucheray, 8/1)
NPR:
After COVID, The New CDC Director Is Focused On Building Trust With The Public
The pandemic was a chance for the Centers for Disease Control and Prevention to do what it does best. Instead, that public health crisis left the CDC marred by political interference and criticism of confusing messaging — and the agency lost trust among Americans. Trust is clearly one issue on the mind of the agency's new director, Dr. Mandy Cohen. She mentioned the word more than 50 times at a commencement speech she delivered earlier this year. (Pfeiffer, Lim and Intagliata, 8/2)
Inpatient Hospitals Will Get Bigger Pay Bump From Medicare Than Expected
In April, CMS proposed a 2.8% boost in reimbursements for fiscal 2024. But the agency said Tuesday that it would be 3.1% net increase. In other news, the Blackfeet Tribe of Montana has declared a public health state of emergency over a Medicaid scam.
Modern Healthcare:
CMS To Boost Medicare Pay For Inpatient, Long-Term Care Hospitals
Inpatient hospitals will see a larger Medicare payment hike next fiscal year than first proposed, the Centers for Medicare and Medicaid Services announced Tuesday. Acute care hospitals complying with quality reporting rules and electronic health record guidelines will get a 3.1% net increase in Medicare reimbursements in fiscal 2024 under the hospital inpatient prospective payment system final rule. In April, CMS issued a proposed rule that would have boosted reimbursements 2.8%. CMS also set a 0.2% reimbursement increase for long-term care hospitals. (Berryman, 8/1)
Axios:
Hospitals Cinch $2.2 Billion Medicare Pay Bump
Hospitals secured a $2.2 billion increase in Medicare payments for inpatient services in 2024, according to a final rule issued Tuesday. The 3.1% increase is slightly higher than the rate the Centers for Medicare and Medicaid Services proposed in April. However, the agency did not grant hospitals' request to raise payments further to account for previous underestimates in hospitals costs. (Goldman, 8/1)
In Medicaid updates —
Modern Healthcare:
Addus HomeCare May Exit States If CMS Advances Medicaid Wages Rule
Addus HomeCare may pull out of states with low Medicaid reimbursements if the Centers for Medicare and Medicaid Services moves forward with a proposal requiring states to spend 80% of home- and community-based services funding on caregiver wages. Chair and CEO Dirk Allison challenged the federal government's authority to dictate caregiver wage percentages to states and said a one-size-fits-all mandate would create an administrative nightmare for providers operating across multiple states. Addus HomeCare offers personal care, home health and hospice services in 22 states. (Eastabrook, 8/1)
AP:
Blackfeet Tribe Of Montana Declares Emergency Over Medicaid Scam That Lured Members To Arizona
A widespread Medicaid scam that left an unknown number of Native Americans homeless in metro Phoenix is being declared a public health state of emergency by the Blackfeet Nation of Montana after the Navajo Nation took similar action in June. The scam left an unknown number of Native Americans without shelter in the greater Phoenix area after Arizona’s Medicaid program suspended scores of programs suspected of fraud. The declarations allow the tribes to get staffing and other resources to help people hurt by the scam. (8/1)
Politico Pro:
Medicaid Unwinding May Hamper The Nation's Opioid Response
The end of the Covid-19 pandemic may mark the beginning of a new spike in opioid overdoses. Millions of Americans are likely to lose their Medicaid as Covid-era protections unwind and while some will find health insurance through Obamacare or their employer, many will become uninsured or underinsured. That has public health and addiction treatment experts concerned that opioid abuse — responsible for over 80,000 deaths in 2021 — is about to spike. (Payne and Messerly, 8/1)
Labor Department Sues A UnitedHealth Group Over Claims Denials
The lawsuit alleges UnitedHealth's UMR unit denied thousands of medical claims without reviewing them for medical necessity. Separately, employers are fighting for billing data that health insurers won't reveal. Also in the news: rising prices at independent hospitals.
Modern Healthcare:
Labor Department Sues UnitedHealth’s UMR Over Denied Claims
A UnitedHealth Group unit denied thousands of emergency department and drug screening claims without reviewing them for medical necessity, the Labor Department alleges in a lawsuit initiated on Monday. The complaint filed in the U.S. District Court for the Western District of Wisconsin targets UMR, a third-party administrator within the company's UnitedHealthcare subsidiary, and accuses it of violating the Employee Retirement Income Security Act of 1974. The Labor Department alleges UMR "simply denied" claims without assessing their merit. (Tepper, 8/1)
Bloomberg:
What Health Insurance Companies Won't Reveal About Your Medical Bills
Employers are losing trust in the companies they hire to run their health plans. Kraft Heinz Co. accused CVS Health Corp.’s Aetna of wasting its money by paying fraudulent medical claims. Two union health insurance plans in Connecticut alleged that insurer Elevance Health Inc. routinely overpaid medical bills. And the trustees of a bankrupt trucking company accused insurer UnitedHealth Group Inc. of mismanaging millions of dollars. (Tozzi, 8/2)
Modern Healthcare:
Independent Hospitals Prices Increase Post-Acquisition: Study
Average inpatient prices for commercially insured patients rose 5% after health systems acquired an independent hospital, according to an analysis of commercial claims from 2012 to 2018 showing the prices hospitals negotiate with insurers. Readmission rates for patients receiving cardiac care at those hospitals increased by up to 12%, and remained elevated for three years after the acquisition, researchers found. The paper was published by the Public Policy Institute of Elevance Health, which operates Blue Cross Blue Shield plans. (Kacik, 8/1)
More health care industry developments —
AP:
Amazon Adds Video Telemedicine Visits Nationwide To Its Virtual Clinic
Amazon is adding video telemedicine visits in all 50 states to a virtual clinic it launched last fall, as the e-commerce giant pushes deeper into care delivery. Amazon said Tuesday that customers can visit its virtual clinic around the clock through Amazon’s website or app. There, they can compare prices and response times before picking a telemedicine provider from several options. (Murphy, 8/1)
Stat:
Microsoft Strikes Partnership With Duke Health To Advance Health AI
On Tuesday, Duke Health and Microsoft announced a five-year partnership that will support artificial intelligence applications in medicine, with a focus on building out infrastructure such as cloud-based data platforms. (Palmer, 8/1)
Becker's Hospital Review:
Another Big Health System Starts Billing For MyChart Messages
St. Louis-based BJC HealthCare has begun billing patients for MyChart messages, KMOV reported. The health system didn't specify how much the messages will cost but noted the charges will apply to "complex interactions," according to the July 24 story. ... BJC joins a growing list of health systems that bill for MyChart messages as providers have experienced an explosion in patient portal traffic in recent years. However, hospital executives have differing opinions on the effectiveness of charging for the interactions. (Bruce, 8/1)
St. Louis Public Radio:
SSM Health To Cut Trauma Care At DePaul Hospital In September
SSM Health will stop treating trauma patients at its hospital in Bridgeton next month, a move that will close the last care center of its type in north St. Louis County and send victims of gunshot wounds and other serious injuries to hospitals in St. Louis and Creve Coeur. As a state-designed Level II trauma center, SSM Health DePaul offers around-the-clock availability of surgeons and other specialists who can treat gunshot wounds, complications from car crashes and other serious injuries. The trauma designation will end Sept. 10, SSM officials said. (Fentem and Henderson, 8/1)
In news about health care workers —
San Francisco Chronicle:
Doctors Sue California Medical Board To Halt Implicit Bias Training
A pair of doctors and a group that says it is determined to protect health care from “radical, divisive ideology” sued the Medical Board of California on Tuesday to stop it from enforcing a state law that requires doctors to study the role of implicit bias in treatment. The lawsuit filed in U.S. District Court in San Francisco targets a 2019 state law that describes implicit bias in health care as unconscious “attitudes or internalized stereotypes” that can lead to disparities in care among ethnic groups and by gender or sexuality even when medical complaints are similar. (Asimov, 8/1)
Stat:
Physician Groups Backed By Private Equity Giant Lobby On Mergers
Three large and growing physician groups backed by the private equity giant Welsh, Carson, Anderson & Stowe have hired a prominent lobbying firm to influence federal policy covering mergers and acquisitions. Over the past two weeks, United Musculoskeletal Partners, U.S. Anesthesia Partners, and U.S. Radiology Specialists each registered with Forbes Tate Partners, a lobbying shop founded by political insiders who used to work in President Bill Clinton’s administration. (Herman, 8/1)
NBC News:
CEO Of HCA Hospital In Florida That Allegedly Had Roaches In The Operating Room Leaves Job
The chief executive of HCA Florida Bayonet Point, the Hudson, Florida, hospital whose physicians characterized it as unsafe and unclean in a February NBC News report, has departed after less than four years, according to a memo delivered to the staff Friday. Regina Temple is leaving “to pursue other opportunities outside HCA Healthcare, effective immediately,” the memo said. Temple’s exit seemed sudden, physicians working at the hospital said, as she was engaged in long-term initiatives as recently as mid-July. (Morgenson, 8/1)
Kansas City Star:
Beloved Doctor Gunned Down At Park: North Carolina Police
A beloved doctor and mom was gunned down at a North Carolina park in the middle of the afternoon, officials said. Dr. Gwendolyn Lavonne Riddick, who worked as an OB/GYN, was found shot multiple times next to her Ford Mustang. The 40-year-old was rushed to UNC Health Rockingham hospital, where she died Sunday, July 30, according to her former employer and the Eden Police Department. (Jasper, 8/1)
Stat:
Verily Hires Former Apple Health Leader As Chief Scientific Officer
As Verily aims to get on track, the Alphabet life science company has hired Andrew Trister, an oncologist and veteran of big technology companies and research, as its new chief scientific officer. (Aguilar, 8/1)
Also —
Becker's Hospital Review:
Black Med Students 50% More Likely To Leave MD Training, Study Finds
Half of Black medical students pursuing an MD degree leave before finishing — an attrition rate that is significantly higher than that of their peers, research published July 31 in JAMA found. ... Between the 2004 and 2012 study timeframe, only 17 percent of White MD students did not finish their training compared to 29 percent of Black students. (Hollowell, 8/1)
Henrietta Lacks' Family Settles Over Research Use Of Her Cancer Cells
The cells, known as HeLa, had "remarkable properties" allowing endless reproduction for medical research purposes, NPR explains, but they were taken without Henrietta Lacks' consent in 1950s. The settlement was reached with her family on what would have been her 103rd birthday.
NPR:
Henrietta Lacks' Family Reaches Settlement Over Use Of Her 'Stolen' Cells
The family of Henrietta Lacks has reached a settlement with a science and technology company that it says used cells taken without Lacks' consent in the 1950s to develop products it later sold for a profit. ... Those cells — now known as HeLa cells — had remarkable properties that allowed them to be endlessly reproduced, and they have since been used for a variety of scientific breakthroughs, including research about the human genome and the development of the polio and COVID-19 vaccines. (Hernandez, 8/1)
The Boston Globe:
Family Of Henrietta Lacks And Waltham-Based Thermo Fisher Settle Lawsuit Over Use Of HeLa Cells
Lacks’s cells were taken at Johns Hopkins Hospital in Baltimore in 1951 when she underwent treatment for cervical cancer. They were eventually used to create a cell line named after her, HeLa (pronounced hee-la). It is the most prolific and widely used human cell line in biology. Thermo Fisher said in an unsuccessful motion to dismiss the suit in January that among its more than 100,000 products, “a handful are HeLa-related.” But it said HeLa cells were first commercialized by others almost immediately after a Johns Hopkins researcher obtained them. (Saltzman, 8/1)
Stat:
What Henrietta Lacks Settlement Says About Racism In Medicine
For what would have been Henrietta Lacks’s 103th birthday, her family got her some justice: A settlement with Thermo Fisher Scientific over the Massachusetts-based company’s use of cells obtained without her consent seven decades ago. The story of Lacks, a Black woman whose cells have contributed to scientific breakthroughs ranging from the development of polio and cancer treatments to the mapping of the human genome, is one of the best-known tales of the exploitation of marginalized groups in the name of medical progress. (Merelli, 8/1)
The Conversation:
Who Was Henrietta Lacks? Here’s How HeLa Cells Became Essential To Medical Research
In an amazing twist of fate, the aggressive cervical cancer tumor that killed Henrietta Lacks, a 31-year old African American mother, became an essential tool that helped the biomedical field flourish in the 20th century. As a cancer researcher who uses HeLa cells in my everyday work, even I sometimes find it hard to believe. On Aug. 1, 2023, over 70 years after doctors took Lacks’ cells without her consent or knowledge, her family reached a settlement with biotech company Thermo Fisher. Lacks’ descendants had sued the company in 2021 for making billions of dollars off her cells. The family has not been previously been compensated. (Martinez, 8/1)
Report Says Intas Pharma Employees Violated Drugmaker Protocols
In response to an earlier inspection by the FDA of what Stat calls a "troubled plant," a recent warning letter was sent alleging that Intas employees tried to destroy manufacturing documents and that an employee failed to report all test results on product samples. Also in the news: a birth control pill recall and more.
Stat:
Intas Pharma Employee Used Acid To Destroy Manufacturing Records At Troubled Plant
Last November, an employee at Intas Pharmaceuticals, which makes several widely used chemotherapies that are in short supply, was seen pouring acetic acid in a trash bin containing documents at a manufacturing facility. Another employee failed to report all test results on product samples and, at times, printouts were tossed in the trash. Plastic bags filled with torn and discarded important production records were stashed under a stairwell and on a truck parked outside. (Silverman, 8/1)
More factory trouble —
FiercePharma:
Lupin Pharma Recalls Birth Control Pills Deemed Possibly Ineffective
Lupin Pharmaceuticals, the U.S. unit of India’s Lupin Limited, issued a voluntary recall of two lots of birth control pills due to the potential that they may not be effective in preventing pregnancy. The company is pulling two lots of Tydemy tablets due to out-of-specification test results at the 12-month stability time point, the company said in a July 31 press release. Testing on one of the lots found low levels of ascorbic acid and high levels of a “known impurity,” Lupin said. The company didn’t identify the impurity. ... Lupin is no stranger to recalls and run-ins with the FDA. Last November, the company disclosed it received a Form 483 at its active pharmaceutical ingredients plant in Mandideep, India, marking the fourth such admonition it received from the regulatory agency in a nine-week period. (Keenan, 8/1)
FiercePharma:
New York Manufacturer SterRx Shutters Plant, Lays Off 161
New York-based manufacturer SterRx has turned off the lights at its Plattsburgh, New York, plant and let go of 161 employees in the process. ... In July 2022, the agency slapped the facility with a warning letter, detailing numerous issues including products being exposed to “insanitary conditions" and other substandard manufacturing practices. (Becker, 8/1)
In other pharmaceutical updates —
Bloomberg:
Adderall Shortage Has US FDA, DEA Urging ADHD Drugmakers To Boost Production
US drug regulators and law enforcement officials asked pharmaceutical companies to manufacture more Adderall, an ADHD medication that has been in short supply for nearly a year. The Food and Drug Administration, which reviews drugs for safety and effectiveness, and the Drug Enforcement Administration, which polices controlled substances like stimulants, “have called on manufacturers to confirm they are working to increase production,” the agencies wrote in a letter Tuesday. (Swetlitz, 8/1)
Stat:
EQRx, Failed Developer Of Low-Priced Cancer Drugs, Is Sold For Cash
EQRx is done, sold for its cash. The once-buzzy but now dormant biotech company is being acquired by Revolution Medicines, a developer of cancer drugs, the companies announced Tuesday. The all-stock deal is essentially a balance-sheet transfer of $1 billion in cash from EQRx to Revolution. What was left of EQRx’s drug pipeline is being shelved. (Feuerstein, 8/1)
KFF Health News:
The Real Costs Of The New Alzheimer’s Drug, Most Of Which Will Fall To Taxpayers
The first drug purporting to slow the advance of Alzheimer’s disease is likely to cost the U.S. health care system billions annually even as it remains out of reach for many of the lower-income seniors most likely to suffer from dementia. Medicare and Medicaid patients will make up 92% of the market for lecanemab, according to Eisai Co., which sells the drug under the brand name Leqembi. In addition to the company’s $26,500 annual price tag for the drug, treatment could cost U.S. taxpayers $82,500 per patient per year, on average, for genetic tests and frequent brain scans, safety monitoring, and other care, according to estimates from the Institute for Clinical and Economic Review, or ICER. The FDA gave the drug full approval July 6. About 1 million Alzheimer’s patients in the U.S. could qualify to use it. (Allen, 8/2)
Also —
The Baltimore Sun:
Nobel Laureate, Hopkins Researcher Retracts Additional Articles, Bringing Total To Six In Two Years
Johns Hopkins Medicine researcher Dr. Gregg Semenza, a Nobel laureate recognized for his contributions to uncovering how cells adapt to changing oxygen levels, has retracted six articles from prominent scientific journals in the past two years after questions were raised about the integrity of images used in them. The questions about the images arose on PubPeer, an online platform for scrutinizing research post-publication. An additional 10 of Semenza’s papers have been corrected, according to PubPeer, and one has been marked with an “expression of concern,” alerting readers to a potential problem. (Roberts, 8/1)
A Third Of Rural Hospitals In Missouri At Risk Of Closing: Report
In a July report, the Center for Healthcare Quality and Payment Reform found that 19 of the 57 rural hospitals in the state have serious financial problems that put them at risk of closure. Also in the news: a huge site in Houston is set to become a biomanufacturing campus.
The Missouri Independent:
One-Third Of Missouri’s Rural Hospitals At Risk Of Closure, New Data Shows
One-third of Missouri’s rural hospitals are at risk of closing, according to a report using newly updated federal data. A July report from the Center for Healthcare Quality and Payment Reform, a national policy group, found that 19 of Missouri’s 57 rural hospitals are at risk of shuttering because of “serious financial problems.” Many of those hospitals at risk of closure could sustain themselves financially for six to seven years, according to the report. (Bates, 8/1)
In other health news from across the U.S. —
The CT Mirror:
CT Nursing Home Residents, Families Plead For Higher Staffing Levels
Nursing home residents and their loved ones told state health officials Tuesday that care in Connecticut facilities is woefully inadequate, leaving some people stranded for hours without trips to the bathroom, diaper changes or meals, and that neglect from understaffing has caused injury, infection and death. (Carlesso and Altimari, 8/1)
Houston Chronicle:
45-Acre Biomanufacturing Campus Planned In Northeast Houston
As Houston angles to become the next big biomedical powerhouse, Houston real estate developer McCord Development is aiming to tap into some of the region's life sciences growth with a 45-acre biomanufacturing hub northeast of downtown. McCord Development has been quietly laying the groundwork to develop a life-sciences cluster at its commercial district for the past few years. Two years ago, Generation Park was on the short list of potential sites slated for a $550 million biomanufacturing plant for pharmaceutical company Amgen. Instead Amgen picked North Carolina's Research Triangle, turning down about $110 million incentives offered by Texas, according to media reports. (Luck, 8/1)
CBS News:
Weather Conditions Cause Valley Fever Fears To Increase In Northern California
Fears over Valley fever are ramping up as the California Department of Public Health warns our historically wet winter, followed by dry and dusty conditions could be the perfect storm for increased risk of contracting the virus. Valley fever, also known as coccidioidomycosis, is a disease caused by a fungus that grows in the soil and dirt. Hotbed areas are typically the Central Valley, but Dr. Stuart Cohen, the co-director for the Center for Valley Fever, said an upward trend in temperatures in recent years is contributing to a rise in Sacramento and the Northern California region. (Sowards, 8/1)
Axios:
988 Calls, Texts For Mental Health Help In Minnesota Spike In Year One
Minnesotans experiencing mental health crises are increasingly turning to texts for help. Texts to Minnesota's suicide prevention and mental health hotline have increased more than 900% in the 10 months since the hotline rebranded to 988 last summer, per Minnesota Department of Health data. (Van Oot, 8/1)
Key Biscayne Independent:
Miami’s Top Cop Shot Himself. Mental Health Remains An Issue For First Responders
Last year, 64 police officers were fatally shot in the line of duty. There were 160 who took their own lives. The biggest threat to law enforcement officers — and often, their families — is not any armed criminal. It is themselves. (Pacenti, 8/1)
If you are in need of help —
Dial 9-8-8 for 24/7 support from the Suicide & Crisis Lifeline. It's free and confidential.
On the opioid crisis —
AP:
Seattle Mayor Proposes Drug Measure To Align With State Law, Adding $27M For Treatment
Seattle Mayor Bruce Harrell is asking members of the City Council who voted against adopting the state’s controlled substance law to consider an amended plan. Harrell is offering a proposal that would align the city’s code with new state law, making possession and public use of drugs such as fentanyl, a gross misdemeanor. But it would also emphasize diversion and health programs and spend $27 million to pay for opioid treatment and related facilities. Seattle saw a 72% increase in overdose deaths from 2021 to 2022. (8/1)
San Francisco Chronicle:
S.F. Supervisor Matt Dorsey Compares Fentanyl Crisis To AIDS Epidemic
Supervisor Matt Dorsey likened San Francisco’s fentanyl crisis to the 1980s AIDS epidemic during a televised town hall Monday and pledged to work on “jail health” and intervention strategies to combat the deadly emergency that has already claimed more than 300 lives this year. (Toledo, 8/1)
St. Louis Post-Dispatch:
St. Louis County Drug Deaths Down 11% Last Year, Marking Biggest Drop In Almost A Decade
St. Louis County recorded a decrease of almost 11% in drug-related deaths last year, marking its biggest year-over-year decrease in almost a decade. Data provided by the St. Louis County Medical Examiner’s Office showed the county’s first decrease in drug-related deaths since 2015, when it reported a drop of almost 8%. Since then, about one-third of the drug deaths in Missouri have come from the St. Louis region. (Vargas, 8/1)
KFF Health News:
Repeating History: California County Plugs Budget Gap With Opioid Settlement Cash
Over the past two years, as state attorneys general agreed to more than $50 billion in legal settlements with companies that made or sold opioids, they vowed the money would be spent on addiction treatment and prevention. They were determined to avoid the misdirection of the tobacco settlement of the 1990s, in which billions of dollars from cigarette companies went to plug budget gaps instead of funding programs to stop or prevent smoking. But in at least one California county, history is repeating itself. And across the country, many local leaders are finding themselves in similar positions: choosing between paying bills due today or investing in the fight against an ongoing crisis. (Pattani, 8/2)
Artificial Intelligence Can Improve Breast Cancer Detection By 20%
Politico reports on the first randomized controlled trial to examine the use of AI in breast cancer screening. In other news, a study is looking into the high incidence of prostate and breast cancer among people with African ancestry. Also: peanut allergy in childhood, adult measles, and more.
Politico:
AI Improves Breast Cancer Detection Rate By 20 Percent
Artificial intelligence is able to accurately detect 20 percent more breast cancers from mammograms than traditional screening by radiologists, according to early results from a Swedish trial published overnight. The study is the first randomized controlled trial to look at using AI in breast cancer screening and comes amid a dramatically shifting landscape for the technology and how it’s regulated. (Furlong, 8/2)
In other health and wellness news —
Stat:
High Incidence Of Prostate And Breast Cancer Among Those With African Ancestry Is The Focus Of New Study
For almost 44 years, Willie Bell never missed his appointment to check for prostate cancer. But then the pandemic hit. The doctor’s office was closed. Three months passed before he was able to be screened in January 2021. “So the doctor kept putting it off and I call him and say, ‘listen I get my PSA level checked every year. I would hate for you to tell me that you backed me off for a year, then you find cancer, because I’ll be pissed off,’” said Bell, a 66-year-old retired police officer who lives in Miami. When Bell’s doctor finally came back to him, the doctor had bad news. Bell was pissed. (Balthazar, 8/1)
The Washington Post:
Infant Peanut Exposure Can Prevent Allergies, But Parents Worry
Exposing infants to peanuts between 4 and 6 months of age can potentially prevent peanut allergies, yet many parents remain anxious about the prospect and aren’t aware that it’s safe, new research shows. ... When more than 3,000 parents and caregivers of infants and young children were asked about the practice, nearly 9 in 10 weren’t aware of the new guidelines. (Camero, 8/1)
Stat:
Adults Seen As Increasingly Susceptible To Measles
Simon Matthews made three trips this spring to the emergency room of his local hospital in Eastbourne, on England’s southeast coast, before doctors managed to figure out what was making him so ill. He had a fever of 104 Fahrenheit, uncommonly high for an adult. On his first foray to the hospital — in an ambulance — it was feared he had meningitis. Cleared of that, Matthews, 62, was sent home with a vague diagnosis; doctors believed he had an unidentified viral infection. (Branswell, 8/2)
CIDRAP:
Experimental Study Suggests Bed Bugs Could Be Vector For MRSA Spread
The results of an experimental study suggest bed bugs may be able to acquire and transmit methicillin-resistant Staphylococcus aureus (MRSA), researchers reported yesterday in the Journal of Infectious Diseases. (Dall, 8/1)
CNN:
What Is Gianotti-Crosti Syndrome, The Condition Affecting Mandy Moore’s Son? Experts Explain
Actor Mandy Moore’s son recently woke up to a startling rash covering his body, according to her Instagram posts. It took trips to urgent care, the pediatrician, a dermatologist and a pediatric dermatologist to figure out what was causing him to itch all over his arms, legs and feet. The cause? Gianotti-Crosti syndrome. (Holcombe, 8/1)
AP:
3 US Marines Died Of Carbon Monoxide Poisoning In A Car. Vehicle Experts Explain How That Can Happen
The seemingly accidental deaths of three U.S. Marines who suffered carbon monoxide poisoning in a parked car at a North Carolina gas station have raised questions about how the situation could have occurred outdoors. Deputies from the Pender County Sheriff’s Office had found the men unresponsive in a privately owned Lexus sedan in the coastal community of Hampstead. (Schoenbaum, 8/1)
KFF Health News:
Listen To The Latest ‘KFF Health News Minute’
This week on the KFF Health News Minute, we look at how airplane regulations add hurdles to lifesaving organ donation and the cancer risks associated with chemical hair straighteners. (8/1)
Read recent pharmaceutical developments in KFF Health News' Prescription Drug Watch roundup.
USA Today:
Antibiotics Can (And Will) Stop Working. Is Modern Medicine Ready?
In some ways, Melanie Lawrence is living a future that awaits us all. She's resistant to nearly every antibiotic and allergic or intolerant to the rest. Now when she gets an infection, which she does every few months, she has to hope her immune system can fight it without much help from modern medicine. Despite more than a century of antibiotic research and development, the world is quickly running out of these lifesaving drugs. (Weintraub and Rodriguez, 7/23)
The Boston Globe:
Can You Cure Lyme Disease? A Cancer Drug May Provide Treatment
A type of drug used to treat some cancers could be effective in halting the symptoms of tick-borne Lyme disease, a bacterial infection that affects nearly half a million Americans each year, according to a new study conducted by researchers at the University of Massachusetts Amherst. (Fox, 7/28)
Stat:
Gene Therapy Is In Crisis. Its Top Minds Searched For A Solution
Jennifer Puck has successfully treated 10 children with a gene therapy for a fatal disorder that decimates their immune system. But she has no idea how to get her drug approved and frankly is running out of ideas. “I wish I had a clue about where to go from here,” said Puck, an immunologist at University of California, San Francisco, from a plush chair above Union Station. The problem is simple: Size. Puck’s therapy is for a disease, Artemis-SCID, that affects just two to three new U.S. patients every year — far too few for a company to generate a profit, or to even run the kind of studies regulators usually demand before approving drugs. (Mast, 7/31)
Stat:
What AstraZeneca-Pfizer Deal Means For Early-Stage Gene Therapy
AstraZeneca said Friday it will buy up a group of early-stage gene therapies from Pfizer, bucking a trend of drugmakers axing programs and exiting a field that had once captured the imagination — and checkbooks — of many pharmaceutical executives. AstraZeneca will pay Pfizer up to $1 billion plus royalties for the portfolio of treatments, none of which has entered clinical trials yet. The companies did not say how much it is paying upfront. (Mast, 7/28)
AP:
Biogen To Bulk Up Rare Disease Treatments With $7 Billion Reata Acquisition
Biogen is spending more than $7 billion to buy Reata Pharmaceuticals and bolster its rare disease treatments. The Alzheimer’s treatment developer said Friday it will pay $172.50 in cash for each share of Reata in a deal it expects to close by the end of this year. (Murphy, 7/28)
CIDRAP:
Antibiotic Stewardship Efforts May Miss Not-In-Person Prescriptions
Focusing ambulatory antibiotic stewardship interventions on in-person visits only may miss a substantial proportion of inappropriate prescribing, according to a study published yesterday in PLOS One. The study authors say the findings, which are based on ambulatory antibiotic prescribing data collected prior to the COVID-19 pandemic, could take on greater significance with more outpatient healthcare visits now being conducted virtually. (Dall, 7/28)
Reuters:
AstraZeneca CEO Says Lung Cancer Drug Trial Data 'Very Encouraging'
AstraZeneca Chief Executive Pascal Soriot said on Friday the company is "very encouraged" by interim data from a key lung cancer drug trial, but he did not explain why the company had not declared results as "clinically meaningful". (Fick and Mason, 7/28)
Stat:
Biogen To Acquire Reata Pharmaceuticals In $7 Billion Deal
Biogen on Friday said it would acquire Reata Pharmaceuticals, the maker of an approved therapy for a rare neurological condition, in a deal worth $7.3 billion. The transaction price of $172.50 per share is a nearly 60% premium from Reata’s share price at Thursday’s close. The deal is expected to close by the end of the year. (Joseph and Feuerstein, 7/28)
Stat:
Sage Hopes For A Blockbuster In Antidepressant Now Before FDA
Cheryl Meier had watched clinical trial enrollment announcements for years — but always for her sons’ type 1 diabetes, never for herself. Her OB-GYN had put her on Effexor for her depression 20 years ago, and it worked well enough — she could sleep for the first time in her life, and she no longer cried at every little thing. But it never worked for her dark thoughts. But then she retired, and then she had time, and then she saw an email — “I guess once your name gets on a list, it’s there,” she said — for an experimental depression drug called zuranolone. (Trang, 7/31)
Perspectives: Should Obesity Drugs Be Covered By Insurance?; Drug Rebate System Is Failing Patients
Read recent commentaries about drug-cost issues.
Fresno Bee:
Weight Drugs Like Ozempic Will Save Lives, But Price Is Issue
New weight loss drugs powerful enough to help obese patients lose up to a fifth of their total body weight might become the highest-selling medication class ever. The price tag for these treatments? About $1,000 a month.
The Tennessean:
How Drug Makers Make Your Prescriptions Unaffordable
Our neighbors are concerned about facing rising costs of health care, and rightfully so.For insulin, the list price has risen over 140% in the last 10 years, forcing patients to ration – tragically, even abandon – their prescriptions. (John Anderson, 7/28)
Stat:
I Learned The Hard Way That U.S. Airlines Are Not Currently Required To Have EpiPens
I was in seat 20C on a flight home this March, when I felt my throat closing. Minutes earlier, hives had appeared on my face and chest. As a physician, I knew exactly what these symptoms meant: anaphylaxis, a severe allergic reaction so precipitously fatal that putting a breathing tube down someone’s throat is sometimes necessary. What I needed was an epinephrine autoinjector, also known as an EpiPen, but neither the airplane emergency medical kit nor any other passenger had one. (Lindsey Ulin, 8/1)
Stat:
New Attacks On The Drug Industry Would Have Made My Breakthrough Sickle Cell Treatment Impossible
Our family doctor, a leading figure in the community, inspired me to follow in his footsteps and help people in need. Years later, while working as a physician in Massachusetts, I was appalled to observe how many medicines failed to benefit society’s most vulnerable, in particular people of color. I soon shifted my career into drug development, because I felt I could improve health care on a bigger scale through innovation. (Ted W. Love, 7/31)
Bloomberg:
Drugs For Obesity And Alzheimer's Propelled Eli Lilly To The Top
Two of the biggest stories in medicine this year — the arrival of the first disease-modifying treatments in Alzheimer’s and the stunning transformations made possible by new weight-loss drugs — have something in common: Eli Lilly & Co. (Lisa Jarvis, 7/31)
Viewpoints: Black Lung Disease Is On The Rise In Appalachia; UK's NHS Is Falling Apart
Editorial writers delve into black lung disease, the NHS, mental health and more.
The New York Times:
Black Lung Disease Is Making A Comeback With Coal Miners
By the end of the last century, thanks, in part, to federal safety standards, severe black lung had nearly been eliminated. But with changes in technology and conditions in coal mines in central Appalachia, cases of severe black lung disease are back to the highest level in decades after the last major study, in 2018. As of that year, more than one-fifth of experienced Appalachian miners have black lung. (Drew A. Harris, 8/2)
Bloomberg:
The UK's Health-Care Breakdown Demands Radical Thinking
Britons have long been devoted to their National Health Service, founded on the principle of universal health care, free at the point of delivery. At the same time, they’ve often grumbled about the standard of the health care it provides. (8/2)
Dallas Morning News:
New Biden Rule On Mental Health Is A Good Step
The Biden administration is requiring health insurers to study whether subscribers have equal access to medical and mental health benefits, and to take steps to level them. That’s a worthy project, even if enforcement will be tricky. (8/2)
VC Star:
Medical Misdiagnoses And How To Minimize Them
The Johns Hopkins Armstrong Institute Center for Diagnostic Excellence recently published a report about the impact of incorrect diagnoses in the U.S. The investigators estimated that 371,000 patients died and another 424,000 patients were permanently disabled by misdiagnoses annually. These estimates are in the same ballpark as prior reports, and include patients seen in physicians’ offices, emergency departments, and in-hospital. (Dr. Irving Kent Loh, 7/29)
Stat:
‘Oppenheimer’ And The Risks Of AI In Health Care
All great stories have complicated endings. But that doesn’t mean they can’t offer simple and instructive lessons. Christopher Nolan’s magnum opus, “Oppenheimer,” highlights the tragic story about the “father of the atomic bomb.” But it’s also a story about how the United States missed an opportunity to be a global leader in the development of an innovation that would define the 20th century. This century will be defined by transformational technologies — especially artificial intelligence — and J. Robert Oppenheimer’s story offers particularly salient lessons for health care leaders, entrepreneurs, and policymakers. (Junaid Nabi, 8/2)
Stat:
The High Personal Cost Of Affirmative Action For Black Doctors
I should be irate and despondent about the Supreme Court’s scrapping of affirmative action in admissions. It’s several steps backward. And yet, I have mixed emotions about the practice, informed by my own experiences with affirmative action. (Jennifer Adaeze Okwerekwu, 8/2)
Stat:
What The Airline Industry Can Learn From Medicine
Over the past decade, the health care industry has grown adept at responding to disasters. A panoply of events (including but most certainly not limited to a pandemic, wildfires and poor air quality, and recurrent patient surges) have given health care organizations extensive opportunity to refine their approach to disaster preparation and response — lessons the airline industry might find useful. As a frontline physician and director of disaster preparedness for a California health care organization, I offer the following tips to the airline industry. (Mary C. Meyer, 8/1)