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Saturday, March 15, 2025

'China should not prioritise low prices in drug procurement plan, European lobby group says'

A European business lobby group urged China to take steps not to prioritise low prices over product safety in the country's centralised drug procurement programme.

The European Union Chamber of Commerce in China also questioned China's recent investigation into quality concerns of off-patent medicines approved for the programme, calling it "unscientific," and lacking in transparency.

China's National Healthcare Security Administration (NHSA) launched an investigation in January after local media cited doctors in Beijing and Shanghai saying the cheaper generic drugs used at public hospitals did not appear to have the same efficacy or side effects as those made by Western pharmaceutical companies.

The regulator said it had looked into those claims by speaking to relevant experts as well as the heads of seven hospitals and concluded last month that the quality concerns were unsubstantiated.

The European chamber, whose online member directory lists drugmakers and hospitals operating in China, said the probe lacked transparency, because an "in-depth explanation" of its process, and data from it, had not been made public.

"The investigation was deemed unscientific due to a lack of transparency," it said in a statement to Reuters.

Jens Eskelund, the chamber's president, said in a separate statement that it "hopes to see steps taken to ensure that the procurement system for drugs does not prioritise low prices at the expense of product safety and clinical outcomes."

The NHSA did not respond to a Reuters request for comment on the chamber's concerns about the investigation.

An official report issued earlier this month said China would "refine the policy for centralized medicine procurement and enhance quality evaluations and oversight" to ensure consumers' confidence in the medication they use.

China rolled out the bulk-buy programme in 2018 in an attempt to negotiate lower prices from drug manufacturers and has since expanded it to many parts of the country.

The drugs on the list include off-patent blockbusters made by Western pharmaceutical giants as well as generics produced by local players.

While the scheme puts pressure on margins, many drugmakers participate in the tenders to supply public hospitals in large volumes.

https://www.msn.com/en-ae/money/companies/china-should-not-prioritise-low-prices-in-drug-procurement-plan-european-lobby-group-says/ar-AA1AUQKz

FAA Calls for Boeing 787 Bulkhead Inspections Amid Manufacturing Defects

Affects 135 US-registered 787s, which appears to encompass the entire US fleet.

The Federal Aviation Administration (FAA) requires airlines to inspect Boeing 787 forward-pressure bulkheads to address concerns about manufacturing defects that create gaps in the aircraft structure.

The regulatory body released a notice of proposed rulemaking on March 12 outlining these requirements.

FAA Calls for Boeing 787 Manufacturing Defects With Bulkhead Inspections — Photo: Boeing

Boeing 787 Inspections

Boeing maintains that the issue, which has been known for several years, does not compromise the safety of 787 aircraft. The company proactively addressed the concern in October 2024 by issuing an Alert Requirements Bulletin recommending the inspections that the FAA now seeks to mandate.

“The FAA has received reports indicating multiple non-conformances, including excessive gaps and pull-up, were found during the assembly and installation of the forward-pressure bulkhead,” the FAA stated in its notice. “These conditions are caused by insufficient clamp-up and non-conformance to the manufacturing process requirements.”

The agency specified that gaps were “found between the Y-chords and attach angles,” which “can allow foreign object debris to become trapped between the parts, and burrs to be present around the holes after drilling.”

If left unaddressed, the FAA warns these problems could “result in undetected fatigue cracks that can grow to weaken the primarily structure” of the aircraft.

The requirement affects 135 US-registered 787s, which appears to encompass the entire US fleet. The FAA will accept comments on the proposal for 45 days.

Issues with 787 forward-pressure bulkheads have been documented since at least 2021. At that time, Boeing committed to rectifying the defects on newly produced jets that had not yet been delivered, while working to determine if 787s already in service might also require fixes.

Issues from Supplier Side

Boeing functional chief engineer Steve Chisholm identified the source of the 787 pressure bulkhead problem in 2024, stating the issue “had to do with a sub-supplier to one of our suppliers, and how they assembled parts.”

Spirit AeroSystems, which supplies Boeing with 787 forward fuselage sections containing the forward-pressure bulkheads, appears to be the primary supplier involved in this manufacturing chain.

The FAA’s new proposal would require operators to complete an “external detailed inspection” of all 787 forward-pressure bulkheads to identify and address these manufacturing defects.

Chisholm described the inspection process last year: “An inspector will have to get to the backside of the forward-pressure bulkhead, they’ll have to pull back insulation blankets, and they do a visual inspection around the circumference of the bulkhead.”

The forward-pressure bulkhead issue represents just one of numerous 787 manufacturing quality problems that have emerged in recent years. Among the highest-profile defects were gaps that failed to meet specifications, including those between fuselage barrel sections.

Despite these concerns, Boeing has consistently maintained that these gap defects pose no safety risk to 787 aircraft. The company asserts that extensive data indicates affected 787 structures will maintain long-term integrity even with these manufacturing anomalies present.

https://aviationa2z.com/index.php/2025/03/15/faa-calls-for-boeing-787-manufacturing-defects/

Inflammation proteins linked to bone density changes over time

In one of the first studies of its kind, a team of researchers from Keck School of Medicine of USC has found that proteins and pathways involved in inflammation are associated with changes in bone mineral density (BMD) over time. Findings from the study were published in the Journal of Bone and Mineral Research.

The research could potentially lead to the identification of biomarkers that would serve as early indicators of a person's risk for bone health issues later in life.

Bone mineral density is a measure of bone strength quantified by the amount of minerals in bone tissue. It peaks during young adulthood and slowly declines over the rest of the life cycle. BMD serves as an important marker for bone health and is commonly used to predict the risk of osteoporosis and other bone health conditions.

"Proteins are also substantial in the formation and maintenance of bone, and recently more studies have been trying to identify individual proteins associated with bone health," says Emily Beglarian, the lead author and an epidemiology doctoral candidate in the Department of Population and Public Health Sciences at the Keck School of Medicine.

The study followed 304 obese/overweight Latino adolescents between the ages of 8 to 13 at baseline from the "Study of Latino Adolescents at Risk for Type 2 Diabetes" over an average period of three years.

The researchers examined associations between over 650 proteins and annual measures of BMD, making this one of the first studies to evaluate these associations over years of follow-up. The proteins found to be associated with BMD were then inputted into a protein pathway database.

"The software determined what pathways the proteins were involved in within the human body. Our primary findings were that many of the proteins associated with BMD were involved in inflammatory and immune pathways in adolescent populations. There are other studies that found some of these same pathways were associated in older adult populations," says Beglarian.

Existing studies suggest chronic inflammation can disrupt normal bone metabolism, leading to lower BMD.

Currently, there are millions of adults in the US living with diseases characterized by low bone mass, and the prevalence is increasing due to our aging population. Childhood is a critical period for the development of BMD and this period can predict lifelong bone health.

"Until now, existing studies have centered on very specific populations. Most of them have small sample sizes, include either Chinese or non-Hispanic white populations, and focus on older adults—primarily on women because osteoporosis is four times more common in women than men," says Beglarian.

"This is one of the first studies to investigate associations between proteins and BMD in younger populations. Investigating bone mineral density in the early stages of life is important to determine how to address factors that may prevent people from reaching their potential peak bone density," says Beglarian.

Advancing the understanding of bone health biomarkers

Additionally, Beglarian examined associations between BMD and a subset of protein markers from the initial proteins, in a separate cohort of young adults. Here she found that several proteins had similar associations with lower BMD. Low BMD is a risk factor for the development of adulthood osteopenia and osteoporosis.

The study's findings could potentially inform the development of biomarkers of bone health to identify people at risk that might benefit from intervention.

"It was interesting to see the way in which our study overlapped and differed with existing studies. Previous research was investigating BMD at the end of life when levels are already much lower," she says.

"Through my research, I hope to address factors that decrease BMD earlier in life to help people get to their highest potential peak density, so they are set up over the rest of their lifetime to have a higher BMD."

More information: Emily Beglarian et al, Proteins and pathways involved in inflammation are longitudinally associated with total body bone mineral density among primarily Hispanic overweight/obese adolescents and young adults, Journal of Bone and Mineral Research (2025). DOI: 10.1093/jbmr/zjaf002

https://medicalxpress.com/news/2025-03-inflammation-proteins-linked-bone-density.html

New insights into the origins of ovarian cancer

Researchers at the University of Pittsburgh have identified a novel trigger for a deadly form of ovarian cancer: a subset of progenitor cells that reside in fallopian tube supportive tissue, or stroma.

The discovery of these high-risk cells, described in a new study published in Cancer Discovery, could pave the way for better approaches to prevent and detect high-grade serous ovarian cancer (HGSOC), the most common form of ovarian cancer, which kills more than 12,000 women in the U.S. each year.

"Ovarian cancer is the leading cause of death from gynecologic cancer in the Western world, but we currently have no way to detect it early and no prevention strategies apart from surgical castration, which is only indicated in high-risk women," said co-senior author Lan Coffman, M.D., Ph.D., associate professor of malignant hematology and medical oncology in the Pitt School of Medicine and member of Magee-Womens Research Institute and UPMC Hillman Cancer Center.

"Understanding the underlying biology of how ovarian cancer forms is critical to improving outcomes for our patients."

HGSOC begins in the fallopian tubes when healthy epithelial cells transform into precursor lesions known as serous tubal intraepithelial carcinoma (STIC). Similar to how precancerous colon polyps can become colorectal cancer, STIC lesions often develop into HGSOC tumors.

But why do healthy cells become STIC? To find out, Coffman and her team turned to the stroma, the non-cancerous connective tissue that helps cancer grow.

"Most researchers have been focused on the epithelial cells that turn into these STIC lesions and eventually into cancer," said Coffman. "Until now, no one has really looked at the surrounding stromal microenvironment of these lesions."

In the stroma of ovarian cancer, a type of progenitor cell normally involved in the growth and repair of healthy tissue (mesenchymal stem cells (MSCs) becomes reprogrammed by tumor cells to support cancer growth. Coffman started by asking when these cancer-associated MSCs form and how early they play a role in cancer formation.

When she and her team profiled MSCs in the fallopian tubes of patients who did not have cancer, they were surprised to find cells that looked like cancer-associated MSCs in these healthy women. These cells, which the researchers named high-risk MSCs, were more common in women with higher risk of ovarian cancer—those of older age or with mutations in the BRCA gene—suggesting that they play a role in cancer initiation.

When the researchers introduced these high-risk MSCs into organoids, or mini-organs, derived from patient fallopian tube tissue, healthy epithelial cells transformed into cancerous cells.

"High-risk MSCs promote DNA damage in epithelial cells and then help those mutated cells survive," explained Coffman. "It's the perfect storm for cancer initiation."

High-risk MSCs also promoted tumor cell growth and increased resistance to a chemotherapy drug.

In search of a mechanism for why high-risk MSCs drive ovarian cancer, the researchers found that these cells have loss of an antioxidant called AMP kinase. Lower levels of AMP kinase led to higher levels of a protein called WT1, which in turn drove the formation of compounds that cause DNA damage.

"This is the first report that stromal changes in the fallopian tube actually have a causative role in ovarian cancer initiation," said Coffman. "It also points to a path where we might be able to intervene."

For example, already existing drugs that upregulate AMP kinase could potentially prevent or reverse early changes in the stroma that lead to ovarian cancer.

The findings could also inform approaches for early detection, which are sorely lacking for ovarian cancer. According to Coffman, compounds secreted by high-risk MSCs that are detectable in the bloodstream could act as biomarkers for early-stage ovarian cancer.

More information: Aged and BRCA mutated stromal cells drive epithelial cell transformation, Cancer Discovery (2025).

https://medicalxpress.com/news/2025-03-reveals-insights-ovarian-cancer.html

Kids under eight shouldn't drink slushies with glycerol

Children under eight should not drink slushy ice drinks containing glycerol, researchers have warned after a string of hospitalizations in the UK and Ireland.

The brightly colored drinks marketed towards children often use glycerol as a sweetener and anti-freezing agent.

But high levels can be harmful, especially to children—glycerol intoxication can cause shock, low blood sugar and loss of consciousness.

In a peer-reviewed medical review published in the Archives of Disease in Childhood journal on Tuesday, researchers looked into a "recent apparent surge in cases" in the UK and Ireland, and suggested children under eight should avoid the drinks entirely.

They studied the medical records of 21 children aged two to seven who needed emergency treatment after drinking slushies.

Most cases took place between 2018 and 2024 and many of the children became acutely ill within an hour, the researchers said.

Most of the children lost consciousness and showed signs of high blood acidity and low sugar, while four needed brain scans and one had a seizure.

The children all recovered swiftly, the researchers said.

Slushy machines were invented in the United States in the 1950s, and the drinks do not always contain glycerol because sugar can be used to stop them freezing solid instead.

The researchers suggested the spate of cases could be linked to increased concern about high sugar consumption and sugar taxes adopted in the UK and Ireland in recent years.

Food safety agencies in the two countries already advise that children aged four and under should not have slushies containing glycerol.

But the researchers said the age should be raised further.

"Younger children, especially those under eight years of age, should avoid slush ice drinks containing glycerol," they said.

"Clinicians and parents should be alert to the phenomenon, and public health bodies should ensure clear messaging."

The review's authors also said there could be cases where children have suffered less serious illness and not been taken to hospital.

In London, some parents said they supported raising the recommended age.

Mother Elsa Qorri, 46, told AFP she became worried after her two girls aged five and seven drank slushies last year.

"They both got brain freeze and couldn't have any more," she said. "I'm not going to buy them again until the girls are a little bit older."

More information: Glycerol intoxication syndrome in young children, following the consumption of slush ice drinks, Archives of Disease in Childhood (2025). DOI: 10.1136/archdischild-2024-328109

https://medicalxpress.com/news/2025-03-kids-shouldnt-slushies.html

NYC Council eases process for illegal migrants to get ID residency cards

The NYC Council’s woke majority passed legislation this week making it simpler for illegal migrants to score already-easy-to-get, city-issued residency ID cards for free benefits — in a move one critic slammed as “legislating against [President] Trump.”

Brooklyn Democratic socialist Shahana Hanif’s bill requires the Department of Social Services to make IDNYC photo-ID cards more accessible, including allowing walk-in appointments at designated centers in each borough and implementing an appeal process for rare cases where applicants are denied.

The Council voted 39-7 in favor of the measure Wednesday.

Critics slammed the bill as nothing more than a direct slap at Donald Trump’s ongoing crackdown on criminal migrants.

“At a time of rising migrant crime and national security threats, it’s reckless — and it just seems like we’re legislating against Trump rather than doing what’s right for New Yorkers,” said Councilman Robert Holden (D-Queens).

“The Access to IDNYC Act guarantees dignity for every New Yorker, especially as federal policies target our transgender, non-binary, and immigrant communities,” said Hanif.

Illegal migrants and others can show more than 120 types of IDs, including expired foreign passports and driver’s licenses, or other papers to obtain an IDNYC card.

Applications are rarely rejected and demand is rising.

The city issued cards to 183,682 — or 91.4% — of 200,922 applicants during the fiscal year ending June 30, according to the annual Mayor’s Management Report released in January.

From July through October, it issued another 64,265 cards, up 14% from the same period a year earlier.

Former-Mayor Bill de Blasio’s administration first offered the cards in 2015 to help migrants more easily access free healthcare in city public hospitals, open bank accounts, sign leases and enroll in school, among other things.

More than 2.3 million cards have been issued since then, records show.

The IDNYC program is “essentially government-sanctioned fraud” to “obtained taxpayer-funded benefits, ” insisted Council Minority Leader Joann Ariola (R-Queens).

“We should scrap this program and incentivize them to go through the proper, lawful process of obtaining citizenship,” said Ariola.

https://nypost.com/2025/03/15/us-news/nyc-council-eases-process-for-migrants-to-get-id-cards/

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