Hims & Hers brings weight loss program to the U.K.

 Expansion Debuts Hers, Unlocking Personalised Care for British Women

Hims & Hers is deepening its commitment to the UK by bringing access to its comprehensive Weight Loss Programme to customers. This expansion includes the official introduction of the Hers platform, helping eligible women across the UK receive access to this holistic weight management care.

Now for the first time through Hers, women in the UK deemed clinically suitable can access a new standard of weight management care that blends convenience with personalised support at every step of their journey.

Sixty four percent of UK adults are overweight or living with obesity, yet access to GLP-1 treatment plans remains challenging on the NHS, and via the private sector due to surging demand and escalating costs. Removing barriers to care, the Hims & Hers digital platform provides eligible British women and men seamless access to its comprehensive, doctor-designed Weight Loss Programme.

Following a thorough, and clinically robust intake assessment conducted by GMC-registered doctors, eligible customers now have access to transparent pricing and personalised weight management programmes, which may include branded GLP-1 options, such as Mounjaro or Wegovy, and the oral non-prescription treatment option, Orlos. Licensed clinicians assess each individual’s medical history, suitability, and contraindications to guide appropriate treatment decisions. Critically, all customers have access to comprehensive support, including 24/7 care team access and content to help improve nutrition, movement, and sleep-based habits along their weight loss journey. This holistic programme is designed to support long-term health, helping customers manage their weight and adopt sustainable lifestyle habits.

Now for the first time through Hers, women in the UK deemed clinically suitable can access a new standard of weight management care that blends convenience with personalised support at every step of their journey. Hers’ customers receive ongoing clinician support through follow-ups and asynchronous messaging, along with treatment adjustments when necessary, keeping care seamless, conversational, and customer-centered. Hers is more than just a telehealth platform; it's where clinical experience meets thoughtful care, resetting women’s expectations and standards for comprehensive and convenient care.

"The launch of Hims & Hers’ comprehensive Weight Loss Programme and the vital introduction of the Hers platform, our dedicated platform for women, represents a significant deepening of our commitment to the UK,” said David Meinertz, GM International of Hims & Hers. “Our doctor-designed treatment plans will complement the NHS by providing accessible, evidence-based, and sustainable long-term weight management care to those who need it, discreetly and conveniently. Our proven model is grounded in clinical excellence, oversight, and convenience, ensuring that every customer receives the thoughtful, thorough, and high-quality care they deserve."

"Obesity is a global epidemic, and the scale of the challenge in the UK requires a comprehensive solution that prioritises long-term health over quick fixes," said Craig Primack MD, Head of Weight Loss at Hims & Hers. "Bringing our trusted, comprehensive approach to the UK will help people lead fuller and healthier lives. And with the launch of the Hers platform, we are ensuring women have access to the dedicated, personalised care they need. Pairing clinically-proven treatments like GLP-1s with holistic support across nutrition and exercise helps make sustainable weight management achievable for the millions battling obesity today."

Launching its Weight Loss Programme marks the company’s continued progress in its mission to make personalised care accessible to millions of people across the UK. Hims & Hers plans to continue to expand into more offerings as demand for access to personalised care continues to grow.

https://www.morningstar.com/news/business-wire/20251210113886/hims-hers-brings-comprehensive-weight-loss-programme-to-the-uk

Antibiotic is first approval in FDA national priority scheme

 The FDA has lost no time in approving the first drug under its recently launched Commissioner's National Priority Voucher (CNPV) programme, clearing an antibiotic manufactured in the US.

The fast track – which allows medicines to be reviewed in as little as one to two months rather than the usual 10-12 months – was introduced earlier this year with the aim of bringing important new therapies to patients more quickly and plugging gaps in the domestic supply of essential medicines.

The first CNPV approval falls into the latter category, and is for a US-manufactured version of the widely used antibiotic Augmentin XR (amoxicillin-clavulanate potassium) that was among the first candidates that entered into the programme.

An initial batch of nine medicines was announced in October, and six more were added last month, including GLP-1 agonist-based weight loss medicines from Eli Lilly and Novo Nordisk.

"Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we're entering a new era of manufacturing here at home," said FDA Commissioner Marty Makary.

According to the FDA, there have been seven shortage reports for amoxicillin and two for Augmentin XR in recent years, which have resulted from global supply chain vulnerabilities for active pharmaceutical ingredients (APIs), many of which – particularly for generic medicines – are not manufactured domestically in the US.

"These shortages have resulted in significant clinical consequences, including treatment delays and increased reliance on broader-spectrum antibiotics when preferred first-line therapies become unavailable," said the agency.

The CNPV system has already proved controversial since it was announced, with concerns raised (PDF) that political appointees rather than career regulators are carrying out the reviews and have been selected for political reasons – for example, as a quid pro quo for pricing deals or investments in domestic manufacturing.

The former head of the FDA's Center for Drug Evaluation and Research (CDER), 25-year FDA veteran Richard Pazdur, reportedly clashed with Makary over the legality of the CNPV system before announcing his retirement just weeks into the job. Meanwhile, George Tidmarsh – Pazdur's equally short-tenured predecessor – has also claimed he was ousted after questioning the scheme.

Makary has previously said the CNPV programme will bring "the agility of frontline medical decision-making to our regulatory processes" and insisted that the FDA's "rigorous standards for safety, efficacy, and quality" will be maintained.

https://pharmaphorum.com/news/antibiotic-first-approval-fda-national-priority-scheme

Germany Plans Largest Single-Year Investment In Arms, Equipment In Its History

 At a moment the Russia-Ukraine war grinds on, and as Trump-led efforts to find peace have been frustrated - largely as Zelensky and his backers have balked at agreeing to any territorial compromise as the bases of a deal - Germany is busy transforming its military with an aim to boost Bundeswehr numbers and meet NATO targets.

That news dominated headlines last week, but added to this Bloomberg is newly reporting Tuesday that the troop expansion will coincide with a major tech and armament expansion, given lawmakers are expected to approve a record €52 billion (about $61 billion) in military procurement contracts next week.

This will mark the largest single-year investment in defense equipment in the country's history, underscoring Berlin's renewed push to modernize its armed forces amid the growing European standoff with Russia.

Source: Rheinmetall

As for 2025 numbers, prior approvals brought total defense commitments for this year to above €33 billion. So next year's could more than double, based on the new projected figures.

Much of the money is expected to flow to German defense manufacturers, including major firms like Heckler & Koch and Rheinmetall, both long well-known known for their advanced military equipment.

The new procurement package covers 73 major projects aimed at upgrading the Bundeswehr. Examples of key items slated for purchase include:

• F-35 fighter jets: Advanced stealth aircraft essential for modern air operations.

• Joint Strike Missiles: Precision munitions that significantly enhance Germany’s strike capabilities.

• Aladin reconnaissance drones: Unmanned systems that will improve real-time surveillance and intelligence collection.

• G95 assault rifles: Modern small arms intended to give soldiers more reliable, effective weaponry.

• Air defense systems: Critical assets to safeguard German airspace from potential threats.

• Armored vehicles: New platforms that boost troop protection and mobility in combat.

• Additional small arms: A range of weapons to better equip personnel for varied missions.

German defense minister Boris Pistorius recently told Germans there was "no cause for concern...no reason for fear...The more capable of deterrence and defense our armed forces are, through armament through training and through personnel, the less likely it is that we will become a party to a conflict at all."

Pistorius and Chancellor Friedrich Merz have set a goal for having Europe's largest military and to be "war-ready" by 2029. Doing its part to promote German militarism, the Wall Street Journal's cited unnamed "military analysts [who] think Russia may be able and willing to attack NATO" by that year. 

https://www.zerohedge.com/military/germany-plans-largest-single-year-investment-arms-equipment-countrys-history

https://breakingthenews.net/Article/Lawmakers-approve-cutting-Bolsonaro's-sentence/65326055

https://www.zerohedge.com/technology/western-colleges-help-build-chinas-digital-dragnet-taxpayer-funds-study-warns

Instacart charging different prices to different customers on same items in same stores: study

 Popular food delivery service Instacart has been using a shady algorithm that charges different prices to different customers on the same grocery items in the same supermarkets without telling them, according to an explosive study.

At a Target store in North Canton, Ohio, the wildly popular grocery app charged a customer $2.99 for Skippy Creamy Peanut Butter one day in September – while other Instacart users that day paid as much as $3.59 for the same jar picked up from the same location, according to the study.

At a Safeway supermarket in Seattle, shoppers using Instacart paid five different prices for the same Oscar Mayer Deli Turkey: $3.99, $4.31, $4.59, $4.69 and $4.89 — a range that spanned a whopping 23% between the lowest and highest markup.

Nearly three-quarters of grocery items in the study published Tuesday were sold at different price points on Instacart.Merrill Sherman / NY Post Design

The same pattern emerged at Target and Safeway stores across four cities, according to Groundwork Collaborative and Consumer Reports, which used 437 shoppers in its survey, ordering groceries off the Instacart app for in-store pickup.

It’s the latest example of so-called “dynamic pricing” — the hated practice introduced more than a decade ago by Uber and Lyft, hiking prices for rides during rainstorms — that is nickel-and-diming consumers, even as relentless inflation has sparked an affordability crisis.

Airlines are known to hike prices when more customers visit their sites at the same time — a tactic known as “surveillance pricing.” Even fast-food junkies claim to have spotted fluctuating prices on burger menus that are increasingly displayed on video screens.

Groundwork, a consumer advocacy group, said Instacart’s pricing algorithm could lead to shoppers forking over an extra $1,200 on groceries each year — even as food inflation has outpaced price increases for other goods since the pandemic.

Nearly three-quarters of grocery items surveyed were sold at different price points on Instacart, one of the largest grocery-shopping apps in the US, according to the study published Tuesday.

In response to a query by The Post, Instacart said its price “tests” are never based on the personal or behavioral characteristics of shoppers. It said its prices were never “dynamic,” meaning they never change in real time, although the study found that they changed wildly depending on who was shopping.

The study found no evidence that Instacart was using personal information, but said it’s almost certain that Instacart and other retailers have the ability to base prices on demographics like age and household income, as well as whether they’re new or returning customers.

Instacart claimed its “tests” help retailers “learn what matters most to consumers.” While the algorithm might charge higher prices on craft beverages or specialty snacks, it often lowers prices on essentials like milk and bread, Instacart claimed.

“Just as retailers have long tested prices in their physical stores to better understand consumer preferences, a subset of only 10 retail partners – ones that already apply markups – do the same online via Instacart,” an Instacart spokesperson told The Post in a statement.

A Target spokeswoman, however, told The Post in a written statement that “Target is not affiliated with Instacart and is not responsible for prices on the Instacart platform.” The Target spokesperson declined to comment on whether the retailer was reviewing Instacart’s practices at its stores.

Albertsons, which owns Safeway, did not immediately respond to The Post’s request for comment.

With grocery prices up 25% since the pandemic, President Trump over the weekend ordered a sweeping investigation into food price-fixing allegations. Several Dem lawmakers have accused food conglomerates of price gouging.

Instacart powers e-commerce for Stew Leonard’s, which operates more than a half dozen supermarkets across the New York metro area. But Instacart has never approached Stew Leonard’s to do variable pricing within the same store — and the grocer says it never would.

“We would never price customer A differently from customer B,” the grocer’s chief marketing officer, Tammy Berentson told The Post. “We would have nothing to gain. It’s unfair. We are transparent about our pricing and we want to be fair to our customers and for our customers to trust us.”

At a Safeway in Washington, DC, a couple of shoppers paid as little as $3.99 for a dozen Lucerne eggs, while others coughed up $4.79 for the same carton. At that same store, some shoppers paid $2.99 for a box of Signature SELECT Corn Flakes, while others were charged as much as $3.69.

A box of Premium Original Saltine Crackers at a Target in North Canton, Ohio, cost $3.99 for some Instacart customers, and $4.59 and $4.69 for some others. Some shoppers paid $1.19 for store-brand farfalle pasta at the same Target, while others were charged $1.43.

Instacart charged shoppers at least four different prices on Wheat Thins at a Safeway in Seattle, at $3.99, $4.31, $4.69 and $4.89.

“Instacart is a black hole for the retailer,” an industry executive told The Post. “The classic rub in the scenario is ‘Whose customer is it’ – Instacart’s or the grocer’s?'”

“The problem is the retailers got into Instacart because it gives them an online presence, but then the pandemic occurred and they realized that they don’t have any visibility into the customer transactions,” the executive added. 

The price changes are powered by Eversight, a software firm that Instacart acquired in 2022.

In a call with investors last year, Instacart CEO Fidji Simo said the new AI technology “helps retailers dynamically optimize their pricing both online and in-store to really figure out which categories of products a customer is more price sensitive on versus less price sensitive on and really adjust their prices based on that information.”

https://nypost.com/2025/12/09/business/instacart-charging-different-prices-on-same-grocery-staples-in-same-stores-study/

'IL-6 Vaccine Shows Early Benefit in Knee Osteoarthritis'

 Vaccine immunotherapy targeting interleukin 6 (IL-6) has shown promising results in the treatment of inflammatory osteoarthritis of the knee, according to a phase 1 double-blind controlled study. Published in Nature Communications, the results demonstrated a good safety profile and an anti-IL-6 immune response in all treated patients.

Although the trial was not designed to evaluate the clinical efficacy of PPV-06, functional improvement was observed at 42 weeks in patients who received all three doses of the vaccine compared with those in the placebo group. Patients with the highest IL-6 neutralization capacity exhibited the best clinical outcomes.

“The results show that PPV-06 is well tolerated and confirm the scientific interest in this innovative active immunotherapy approach targeting IL-6. Given the lack of a curative and lasting solution for patients suffering from osteoarthritis, this is an encouraging first step for further clinical development,” said the study’s lead author, François Rannou, MD, PhD, professor of Medicine, University Paris Descartes, Cochin Hospital, Paris, France, in a press release.

Speaking with Medscape’s French edition, Rannou confirmed the launch in 2026 of a multicenter phase 2 trial in seven European countries to evaluate the efficacy of the vaccine approach in 204 patients with inflammatory knee osteoarthritis. “We will initially use the lowest dose, namely 10 µg of PPV-06, which proved in the phase 1 trial to be as immunogenic as the 50-µg dose.”

The effect of immunotherapy on the bone structure was assessed using imaging. “We hope for at least a halt to the deterioration,” Rannou said. If efficacy is confirmed, the vaccination schedule must be defined. “Will it be necessary to vaccinate every year, every 2 years? A phase 2B trial will be necessary to answer this question.”This approach will also be evaluated for other inflammatory diseases, according to Peptinov, the company that developed immunotherapy.

In 2026, additional phase 2 trials will be conducted to evaluate its effectiveness in preventing relapses of giant cell arteritis and Behçet disease and in the treatment of endometriosis. Other conditions, such as uveitis and Takayasu arteritis, are also under consideration.

PPV-06 immunotherapy, developed by Peptinov, targets low-grade chronic inflammation. “Our company has selected indications in which there are unmet medical needs,” stated Peptinov.

Other conditions are under consideration, “such as uveitis and Takayasu arteritis,” an inflammatory disease affecting the aorta and pulmonary arteries.

Since IL-6 is a key cytokine in low-grade inflammatory processes, “these studies will pave the way for an extension of the clinical development of PPV-06 to other indications related to chronic low-grade inflammation, including those associated with ageing,” the laboratory added.

Expectations for progress are high given the long history of setbacks in osteoarthritis research. The development of anti-nerve growth factor monoclonal antibodies, once considered a promising analgesic approach, was halted in 2021 after the discovery of cases of rapid joint destruction.

According to Rannou, “the idea with vaccine immunotherapy is to regulate IL-6, not inhibit it.” IL-6 levels rise only slightly during inflammatory flare-ups of osteoarthritis, which typically last several weeks to 3-6 months.

In contrast, highly inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease, and ankylosing spondylitis, involve substantial increases in proinflammatory mediators, and intravenous antibody therapies have shown clear benefits.

“There are now few treatments in clinical trials,” Rannou said. Beyond this vaccine approach, current investigations have assessed GLP-1 receptor agonists for slowing osteoarthritis progression, relieving associated pain, and intraarticular botulinum toxin injections, which have also shown encouraging results.

Given the central role of IL-6 in the pathophysiology of osteoarthritis and cartilage degradation, several trials have previously tested anti-IL-6 antibodies, although none have produced conclusive clinical benefits. In this phase 1 study, we evaluated vaccine-based immunotherapy designed to influence IL-6 levels over the long term.

Immunotherapy uses a conjugate vaccine consisting of a fragment of the IL-6 protein linked to a nontoxic mutant of diphtheria toxoid to generate a neutralizing immune response. Preclinical studies have demonstrated the safety and efficacy of conjugate vaccines.

The phase 1 trial included 24 patients with inflammatory knee osteoarthritis (stage 2 or higher) and ultrasound-confirmed effusion. Participants were randomized to receive 10 µg of PPV-06 (n = 9), 50 µg of PPV-06 (n = 9), or placebo (n = 6). Three injections were administered, with two doses administered 1 month apart and a third dose at week 16. Tolerability was good, with mostly mild-to-moderate adverse events, such as injection site induration, erythema, and headache. No serious adverse events were reported.

Immunotherapy induced an immune response in all treated patients, with anti-IL-6 antibody levels peaking 8 weeks after the third injection and then declining gradually in the absence of a booster dose. No memory T-cell response was detected against the conjugated peptide.

Both treatment groups showed a trend toward improvement in the Knee Osteoarthritis Outcome Score at week 42 compared with the placebo group, particularly for pain and quality of life. This trend was more pronounced in patients with a higher anti-IL-6 neutralising capacity.

Vaccine immunotherapy “seems to have more interest” in diseases characterized by low-grade inflammation, Rannou said. He also noted a potential role in conditions such as diabetes and Alzheimer’s disease, “diseases which are micro-inflammatory.” In these settings, “the levels of inflammation regulation are quite low,” which this vaccination strategy could help address.

https://www.medscape.com/viewarticle/il-6-vaccine-shows-early-benefit-knee-osteoarthritis-2025a1000yhv

FDA launches fresh safety scrutiny of approved RSV therapies for infants

 U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would be subject to fresh safety scrutiny following concerns raised by vaccine skeptics, multiple sources familiar with the situation told Reuters.

The preventive therapies - Beyfortus from Sanofi and AstraZeneca and Enflonsia from Merck - would be the latest called into question ​under U.S. Health Secretary Robert F. Kennedy Jr., a long-time promoter of anti-vaccine views who is presiding over a review of routine childhood immunizations.

Kennedy maintains that the potential risks of such pharmaceutical products have not been ‌properly studied. Leading medical societies and many state health officials say Kennedy is trying to dismantle a vaccine program that prevents disease and saves lives based on his beliefs rather than scientific evidence.

FDA officials appointed under Kennedy began making inquiries into the respiratory syncytial virus therapies over the summer, according to ‌sources and internal documents.

Senior FDA adviser Tracy Beth Hoeg began safety questions internally at the agency as early as June, Health and Human Services Department spokesman Andrew Nixon told Reuters. Hoeg had opposed U.S. health policies during the COVID-19 pandemic and has questioned the use of some childhood vaccines.

Maryanne Demasi, an independent journalist based in Australia who has been critical of COVID vaccines, wrote in an August 17 blog post that the RSV therapies could increase the risk of seizures.

Several safety studies have found no such evidence of seizure risk.

George Tidmarsh, at the time director of the FDA division that oversees the RSV therapies, directed staff in late August to compile information about Enflonsia to take a second look at the agency’s approval of the therapy earlier this year, internal documents ⁠reviewed by Reuters show. Beyfortus has been on the U.S. market since July 2023.

Hoeg’s ‌questions within FDA led officials at the agency’s Center for Drug Evaluation and Research to convene a call with the three drug companies last Wednesday to tell them to expect further safety questions from the commissioner’s office, sources familiar with the situation said.

The call was brief, and did not spell out what data might be requested, they said. Hoeg has since been named the ‍acting director of CDER.

It is unclear whether the FDA will ultimately take any actions to change the product label or restrict availability of the therapies. The call with the company executives underscored the seriousness of the inquiry, the sources said.

“FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence," Nixon said in a statement. The agency is "rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science and in the best interest of patients," he ​said.

In a statement Sanofi said the safety and effectiveness of Beyfortus has been demonstrated in over 50 studies involving more than 400,000 infants. Representatives for Merck and AstraZeneca did not immediately respond to requests for comment.

REDUCING RISK FOR INFANTS

Two or ‌three out of every 100 infants under 6 months old are hospitalized with RSV every year, according to federal estimates. For babies at high risk, RSV infection can lead to severe breathing problems and pneumonia and may become life-threatening.

Unlike vaccines, these RSV therapies do not stimulate the immune system to create its own antibodies. Instead, they provide infants with ready-made antibodies to protect against illness in their first six months to over one year of life.

Beyfortus generated combined global sales of more than $2.6 billion in 2024. Merck’s newer Enflonsia is expected to make $250 million in sales next year.

The therapies are included in the U.S. Centers for Disease Control and Prevention’s recommended childhood immunization schedule.

A CDC study of real-world data on Beyfortus and a maternal vaccine showed up to a 43% reduction in RSV hospitalizations for infants during the 2024-25 respiratory illness season, compared to the 2018-2020 periods.

Demasi criticized the CDC's analysis of Beyfortus for considering newborns separately from slightly older babies. She argued in her post ⁠that when data on both groups were combined, there appeared to be a statistically significant risk of seizure.

Some scientists have pushed back against ​the critique. Jake Scott, an infectious-disease physician and Stanford University associate professor, wrote in August that older babies receive multiple vaccines at the same time ​as the RSV therapy, while newborns typically do not.

Analyzing the age groups separately prevents mis-attributing seizures from other vaccines to the antibody, he wrote.

“Rolling back RSV availability based on baseless concerns would do harm to American children,” Scott wrote on Quillette, an online publication. “Perhaps more importantly, it would set a dangerous precedent in regard to how America’s scientific advisory-committee system might be undermined — or even co-opted— ‍by peddlers of junk science.”

HHS spokesman Nixon said Scott’s concerns “are not ⁠baseless,” adding that FDA “must evaluate all evidence through comprehensive reviews.”

Three days after Demasi's post, Dr. Robert Malone, a member of the national vaccine advisory board appointed by Kennedy, said he regretted recommending widespread use of Enflonsia at a June meeting of the committee based on CDC staff analysis.

“I voted in favor of the resolution based on the information and logic presented,” Malone wrote on Substack. “That trust in the data presented now appears to have been ill-advised.”

Malone ⁠and other vaccine advisers on Friday scrapped a long-standing recommendation that all American newborns receive the hepatitis B shot, the most consequential change to date in Kennedy’s remaking of U.S. vaccine policy.

At that same meeting, Hoeg cited data from four late-stage clinical trials involving both RSV therapies that she ‌said showed an “unfavorable imbalance” in mortality, with more deaths in the treatment arm than the control.

While not statistically significant, meaning the finding could be due to chance, Hoeg said the issue “could be revisited” by ‌the committee.

https://ca.finance.yahoo.com/news/exclusive-us-fda-launches-fresh-110832527.html

Material Hardship, 'Catastrophic' Income Loss Common in Families of Kids With ALL

 Almost a third of families of children with newly diagnosed acute lymphocytic leukemia (ALL) had housing or food-related hardships or "catastrophic" income loss during standard chemotherapy, according to a study reported here.

At some point during 2 years of chemotherapy, 30% of families reported household material hardship and 31.5% had income loss ≥25% (catastrophic). Housing insecurity was the primary factor in household material hardship. A fourth of families with no material hardships at ALL diagnosis subsequently had catastrophic financial toxicity during therapy.

"I think one immediate takeaway is that it's really clinically important to standardize repeated longitudinal financial screening over the course of cancer treatment," said Daniel Zheng, MD, from Children's Hospital of Philadelphia, during a press briefing at the American Society of Hematology annual meeting. "This can't be the type of thing where you meet a family at diagnosis, get an initial screen, and then you just assume that the family is going to be fine for the subsequent 2 years."

"This also brings up the critical need for family-centered intervention," he added. "Some of the co-authors of this study are currently leading interventional studies exploring things like benefits counseling and cash transfer as potential interventions to mitigate financial toxicity."

During a discussion that followed his presentation, press briefing moderator Adam Cuker, MD, of the University of Pennsylvania in Philadelphia, asked Zheng, "If there was one intervention that you could implement at your institution right now that you think might make a dent in this problem, what would that be?"

Zheng responded, "I personally am most excited about seeing results for direct cash transfer. I think that is the simplest proof-of-concept that can address financial toxicity. It also lends itself to flexibility. Probably a number of different stressors and factors are involved, and I would imagine they are not the same for every single family. Having something like direct cash transfer allows for the flexibility to help with different patients."

With regard to actions that providers can take to help address financial toxicity issues, Zheng said, "One of the first things that we need to do is identify the problem by simply asking about it."

"We know from a national survey of pediatric oncology social workers that over half of them don't do standardized, systematic financial screening beyond the initial diagnostic period. These results suggest that you're going to miss a substantial number of families who will go on to experience these financial struggles. Most centers have some level of social and financial support that you can plug patients into, so that would be the first thing."

Most providers of cancer care do not have training in financial issues affecting patients and are not accustomed to having conversations with patients and families about the issues, he continued. Providers should "brainstorm" about low resource-intensive strategies that can help mitigate some of the financial burden.

"I remember talking to a family about the price of an antifungal medication and about how there was a dramatic difference in the cost from one formulation to another," said Zheng. "The family had no idea that the formulation really didn't matter to the provider. They thought they had to get the medicine that was prescribed for their child. They were paying an exorbitant amount for a standard antimicrobial prophylaxis. Those kinds of things can make a substantial difference for an individual family."

ALL is the most common childhood cancer, and successful treatment routinely involves 2 years or more of chemotherapy, Zheng noted in his introduction to the study. Treatment can involve as many as 200 outpatient encounters and 40 inpatient days, creating the potential for a significant financial burden on families.

To examine financial issues more closely, investigators surveyed caregivers of children enrolled in ALL clinical trials. Caregivers completed the surveys four times during the patients' 2-year chemotherapy regimen, providing information about household finances. The primary objective was to determine the frequency and characteristics of household material hardship and catastrophic income loss.

Examples of survey items included:

• Was there a time you were not able to pay the rent or mortgage on time?
• Has the gas/electric/oil company sent you a letter threatening to shut off the gas/electricity/oil to the house for not paying bills?

By 24 months, almost a third of the families had endured household material hardship and/or catastrophic income loss. The number of families affected increased fairly rapidly up to 12 months and then accelerated again after 18 months. Material hardship was driven primarily by housing insecurity (22.2%), followed by food insecurity (15.9%) and utilities (8.6%).

A fourth of families with no household material hardship at their child's ALL diagnosis reported new material hardships or catastrophic income loss during chemotherapy, said Zheng.

During an ASH-sponsored webinar reviewing the meeting's press briefings, Jennifer R. Brown, MD, PhD, of Dana-Farber Cancer Institute in Boston, noted that the study is the first pediatric oncology study "to systematically collect data on financial toxicities for families with a child undergoing the 2 years of therapy."

The findings emphasize that clinicians should engage parents in discussions about potential financial stressors earlier in the treatment process.

"Probably not at the very moment of diagnosis, when you're establishing a treatment plan, but as part of your overall strategy for developing the treatment plan for the patient and providing social support to the family," said Brown. "Probably, people should be screened for their risk and their [financial] situation should be discussed. Anything the physician's office can do to try and intervene, we can obviously try to implement."

Disclosures

Zheng reported no relevant financial disclosures.

Cuker disclosed relationships with Novartis, UpToDate, Pfizer, Bioverativ, Novo Nordisk, Stago, Sanofi, MindSight, New York Blood Center, and Synergy.

Brown disclosed relationships with AstraZeneca, Grifols Shared Services, Eli Lilly, ER Squibb & Sons, Genentech, and AbbVie.

Primary Source

American Society of Hematology

Source Reference: Zheng D, et al "Cumulative incidence of household material hardship and income loss as measures of financial toxicity during pediatric acute lymphoblastic leukemia treatment: A report from the DFCI ALL 16-001 trial" ASH 2025; Abstract 710.

https://www.medpagetoday.com/meetingcoverage/ashhematology/118923