Supreme Court to hear cases on whether EMTALA preempts state abortion bans

 A nearly 40-year old federal law requires Medicare hospitals to provide all patients experiencing a medical emergency a medical screening and stabilizing care. Whether that includes abortion has been at the center of several lawsuits in states with strict abortion bans. 

The Emergency Medical Treatment and Labor Act "finds itself on a collision course with conservative states" with strict abortion bans, as The Texas Tribune put it in an April 17 report.

On April 24, the Supreme Court will hear arguments in an Idaho case that asks whether EMTALA preempts abortion bans in certain emergency circumstances. In its lawsuit against Idaho, the Justice Department says the state's abortion ban directly conflicts with EMTALA.

The state's exceptions are too narrow (it permits abortions that treating physicians determine are necessary to prevent a patient's death), the challenge argues, while EMTALA covers a broader scope to prevent harm more wide-ranging than death and requires stabilizing treatment when harm is probable. The Supreme Court is expected to rule on the argument in June, and legal experts say its decision will affect the outcomes of numerous similar cases, including one in Texas, and shape the future of state-level abortion bans. 

"Nobody was thinking about EMTALA" when Roe. v. Wade was overturned in June 2022, Sara Rosenbaum, professor emerita at the Milken School of Public Health at George Washington University in Washington, D.C., told The Texas Tribune. "Except for the handful of us who are really, really steeped in EMTALA, we knew the day would come when the states' standards would come into direct conflict with EMTALA." 

https://www.beckershospitalreview.com/legal-regulatory-issues/supreme-court-to-hear-cases-on-whether-emtala-preempts-state-abortion-bans.html

Worker confidence wanes: LinkedIn poll

 U.S. workers' confidence has dropped by two points since January, according to LinkedIn's most recent Workforce Confidence survey. 

The platform's market research team surveyed 78,988 U.S. professionals from March 11, 2023 to April 5, 2024, and scored their confidence on a scale from -100 to +100. 

Workforce confidence has been on the decline year over year, according to the survey. Workers' confidence that they will find a new job or be able to keep their current one has decreased four points since March 2023, while their confidence that they will progress in their careers this year has dropped three points. 

This pessimism is especially pronounced amongst unemployed Americans. Although this population reported a confidence score of +12 in January — increasingly believing that they could find and hold a job — their confidence has since decreased to -2. Analysts attribute the sharp decline to the leveling out of new-year optimism, and continued concerns about inflation and layoffs.

https://www.beckershospitalreview.com/workforce/worker-confidence-wanes.html

Novant, CHS push back against FTC's 'distorted' antitrust case

Winston-Salem, N.C.,-based Novant Health has fired back against a Federal Trade Commission lawsuit that aims to prevent the health system's acquisition of two hospitals from Franklin, Tenn.-based Community Health Systems. 

The FTC alleges that the proposed $320 million acquisition of Lake Norman Regional Medical Center in Mooresville and Davis Regional Medical Center in Statesville, N.C., poses a risk of increased prices and diminished incentives for investing in quality and innovative care. The agency also argued that the deal would grant Novant control over nearly 65% of the market for inpatient general acute care services in the Eastern Lake Norman area.

Novant is picking holes in the FTC's claims, arguing that they are "premised on a distorted and artificially narrow view of healthcare competition in the Charlotte area," the health system said in a 37-page opposition to the agency's request for a preliminary injunction. 

"For example, the FTC alleges that CHS's lone acute care hospital in North Carolina is the competitive counterweight to Novant in the purported Eastern Lake Norman Area, a geographic construct gerrymandered specifically to exclude Novant's most important competitors. The FTC then bases its case on inaccurate estimates of market shares within that contrived “market,” which it claims make the transaction presumptively anticompetitive."

Novant argues that the FTC has not defined a relevant market that corresponds to commercial realities and cannot prove that the transaction is likely to substantially reduce competition.

"The FTC's 'one-size-fits-all' attack on hospital mergers, echoed by the amicus brief, misses the real-world facts about this transaction: Novant Health's purchase of these hospitals will ultimately benefit quality of care, long-term outcomes and competition," a spokesperson for Novant told Becker's. "Our commitment to purchase is, fundamentally, a commitment to restore services lost over time and to provide new, leading-edge technology that will enhance the clinical capabilities available to the greater Charlotte community."

North Carolina Treasurer Dale Folwell has backed the FTC's lawsuit to block the hospital transaction, but state attorney general Josh Stein — who is running for governor — has remained neutral. 

CHS did not immediately respond to Becker's request for comment. 

The FTC said it has no further comment on the case.

https://www.beckershospitalreview.com/legal-regulatory-issues/novant-chs-push-back-against-ftcs-distorted-antitrust-case.html

'Novel Treatment Appears to Show Benefit in ALS'

 A novel treatment candidate for amyotrophic lateral sclerosis (ALS) met its primary safety and secondary endpoints in the phase IIb PARADIGM trial.

ALS patients treated with PrimeC -- a formulation of two FDA-approved drugs, ciprofloxacin and celecoxib -- had similar safety outcomes as those treated with placebo, reported Merit Cudkowicz, MD, MSc, of Massachusetts General Hospital in Boston, in a late-breaking session at the American Academy of Neurologyopens in a new tab or window annual meeting.

Moreover, scores on the ALS Functional Rating Scale-Revised (ALSFRS-Ropens in a new tab or window) appeared to favor PrimeC at 6 months. In an intention-to-treat analysis, the between-group difference in adjusted ALSFRS-R scores was not significant (2.23 points, P=0.12). But in a per-protocol analysis at 6 months, a difference of 37.4% favoring PrimeC was statistically significant (3.22 points, P=0.03).

PrimeC is designed to synergistically target several key pathological mechanisms of ALS, including neuroinflammation, iron accumulation, and dysregulation of microRNA metabolism, Cudkowicz noted. A small phase IIa trialopens in a new tab or window showed that the treatment had a favorable safety profile and suggested it might slow functional and respiratory decline in ALS.

"Ciprofloxacin -- and actually, all antibiotics in this class -- has been shown to regulate microRNA and also works on iron accumulation," Cudkowicz said in an interview with MedPage Today. "Celecoxib works on inflammation." When given as a single agentopens in a new tab or window in an earlier ALS study, celecoxib did not show benefits.

PARADIGMopens in a new tab or window randomized patients with familial or sporadic ALS to PrimeC (45 people) or placebo (23 people) in Canada, Italy, and Israel for 6 months. The intention-to-treat analysis was based on 68 people and the per-protocol analysis was based on 62. All participants had an upright slow vital capacity (SVC) of at least 60% at enrollment.

In both the PrimeC and placebo groups, 60% of participants were men. Mean age in the PrimeC group was 59 years; in the placebo arm, it was 55. About 90% of participants were on riluzole (Rilutek).

The primary endpoint was safety and tolerability, defined as the time to discontinuation or completion of the assigned treatment in the double-blind period. "Tolerability was quite good, with the majority of participants both in the active and in the placebo group completing the trial on medication," Cudkowicz said.

All adverse events were mild, transient, and expected, she pointed out. Over 6 months, the adjusted predicted SVC mean difference was 17.2% (P=0.39) in the per-protocol dataset and 13.3% (P=0.5) in the intention-to-treat dataset, favoring PrimeC. Trends in neurofilament light (NfL) suggested a small decrease over 6 months with PrimeC.

These findings indicate that PrimeC is safe and may have a positive effect on ALS clinical outcomes, Cudkowicz stated. "We did see a specific significant slowing of disease progression of 37% in the per-protocol population," she pointed out.

The data supported moving forward to a phase III pivotal trial, Cudkowicz added. Further analysis of biomarkers, including efficacy biomarkers TDP-43 and prostaglandin 2, may help shed light on the clinical results, she said.

PrimeC is also being studied in Parkinson's disease and Alzheimer's disease,opens in a new tab or window according to drug developer NeuroSense Therapeutics. Enrollment in the phase II Alzheimer's study is underway.

Disclosures

This study was supported by NeuroSense Therapeutics.

Cudkowicz reported relationships with Biogen, Cytokinetics, Denali, Wave, Transposon, QurAlis, Regeneron, NeuroSense, Arrowhead, VectorY, Eledon, Servier, Roche, Novartis, Ono, Coya, Locust Walk, Pasithea, Praxis Precision Medicine, and Annals of Neurology.

Primary Source

American Academy of Neurology

Source Reference: opens in a new tab or windowCudkowicz M, et al "PrimeC, an oral candidate for amyotrophic lateral sclerosis, meets primary safety and secondary end points in the phase 2b PARADIGM trial" AAN 2024.

https://www.medpagetoday.com/meetingcoverage/aan/109742

'Sluggish' Hospital Uptake of Newer Antibiotics for Gram-Negative Infections

 Hospital uptake of newer antibiotics to treat multidrug-resistant gram-negative bacteria was low over a 5-year period, according to a retrospective cohort study.

Fully 41.5% of episodes of difficult-to-treat resistant (DTR) gram-negative infections were treated exclusively with older, generic agents, which were largely ones with suboptimal safety-efficacy profiles, Sameer Kadri, MD, of the National Institutes of Health Clinical Center in Bethesda, Maryland, and colleagues, reported in the Annals of Internal Medicineopens in a new tab or window. The findings were also presented at the American College of Physicians meetingopens in a new tab or window in Boston.

Use of new antibiotics gradually increased across the study period from January 2016 to June 2021, but gains were uneven across agents. The most commonly used next-generation antibiotics during that time frame were ceftolozane-tazobactam (Zerbaxa) and ceftazidime-avibactam (Avycaz).

Other more recently approved antibiotics -- cefiderocol (Fetroja), eravacycline (Fetroja), imipenem-cilastatin-relebactam (Recarbrio), and meropenem-vaborbactam (Vabomere) -- had more sluggish uptake, Kadri and colleagues wrote. And not even a single hospital used plazomicin (Zemdri) after its FDA approval in 2018opens in a new tab or window for complicated gram-negative urinary tract infections.

"The two most used 'new' antibiotics, ceftazidime-avibactam and ceftolozane-tazobactam, are themselves a decade old and have largely occupied the carbapenem-resistant Enterobacterales and multidrug-resistant [Pseudomonas] aeruginosa niches," the authors wrote. "On the other hand, the five subsequently approved gram-negative antibiotics with partially overlapping pathogen spectrums were markedly underutilized."

Of concern, 79.3% of DTR gram-negative infections were treated with traditional agents known to have suboptimal safety or efficacy, such as polymyxins, aminoglycosides, tigecycline, and chloramphenicol.

"Given the high mortality risk associated with DTR infections, such treatment gaps could risk patient lives," Kadri's group wrote.

They suggested policy change: "Few overall treatment opportunities in the U.S. market and sluggish utilization trajectories for recently approved antibiotics observed in our study reinforce the need for pull incentives," such as subscription models for new antibiotics piloted in the United Kingdom, they suggested, pointing to the PASTEUR billopens in a new tab or window as a potential solution to provide that funding.

"Why are these next-generation antibiotics not being used more often?" wrote Jessica Howard-Anderson, MD, of Emory University School of Medicine in Atlanta, and Helen Boucher, MD, of Tufts Medical Center in Boston. "Antimicrobial stewardship is frequently cited -- however, this represents a fundamental misunderstanding of stewardship, which aims to use the right drug, for the right patient, at the right time," they wrote in an accompanying editorialopens in a new tab or window.

Cost may be one factor, the editorialists posited. Mean wholesale price for a day's dosage averaged across the seven new antibiotics noted in the study was $1,036.69 versus $173.41 for traditional agents.

Another factor may be that clinical trials that evaluated the new antibiotics did not always enroll patients that would need the drugs in practice, Howard-Anderson and Boucher wrote. "Clinicians are therefore left wondering whether these new antibiotics are applicable to their patients."

The study analyzed inpatient admissions from a large retrospective administrative database. Between January 2019 and June 2021, 362,142 inpatient encounters occurred across 299 hospitals that indicated one or more cultures with a gram-negative organism. Of these, 0.7% (2,551) were hospitalizations for DTR gram-negative infections. Overall, the DTR infection prevalence among hospitalized patients was 72.7 episodes per 10,000 inpatient encounters.

P. aeruginosa was the most common DTR pathogen, occurring in 48.2% of infections, followed by Acinetobacter baumannii complex (22%). Enterobacterales species accounted for 23% of infections and other gram-negative pathogens accounted for the remaining 6.8%. Of DTR infections, 42.9% were respiratory tract infections and 8.36% were bloodstream infections.

Several patient factors were associated with increased probability of being one of the 58.8% who were treated with newer, next-generation antibiotics. DTR bloodstream infection was a big factor, with newer agents used for about 72% of these compared with 57% of non-bloodstream infections. Patients presenting with do-not-resuscitate status, acute liver failure, and with pathogenic A. baumannii complex or infections caused by other non-pseudomonal non-fermenters were less likely to receive newer antibiotics.

However, age, gender, race/ethnicity, and ICU admissions were not associated with the probability of receiving newer versus traditional antibiotics, nor were mechanical ventilation or presentation at the hospital with neurologic, renal, or respiratory failure.

Of 299 study hospitals, 107 did not prescribe any of the newer antibiotics for DTR infections over the study period. However, only 3.9% of all DTR episodes occurred in the non-prescribing hospitals, most of which were relatively small, with fewer than 100 beds.

Researchers also found that geographical region mattered. For example, in the Midwest, the marginally adjusted probability of hospitals using newer antibiotics was about 61% versus 34% in the Western states. Also, hospitals that reported susceptibility of the infection to newer agents were more likely to use those agents (60% vs 54% for those with no reporting of susceptibility to the agents). However, urban location, teaching status, and technological or bed capacity did not appear to affect patients' probability of receiving newer antibiotics.

Hospital bed capacity was "the strongest factor associated with nonuse" of newer agents: hospitals with fewer than 100 beds had a 28% probability of using new antibiotics, whereas those with 300 or more beds had a 95% probability of using new antibiotics. In particular, smaller rural hospitals and smaller urban hospitals with low baseline prevalence of antibiotic resistance were less likely to use newer antibiotics.

At baseline, the median age of patients with DTR gram-negative infections was 61 years, 58.5% were men, and 49.1% were non-Hispanic whites. The median Elixhauser Comorbidity Index was 5. About one-third of patients were admitted to the ICU, 22.2% required mechanical ventilation, and 17.6% needed vasopressors. Approximately one in five patients with DTR gram-negative infections died. Mortality was higher in patients with DTR bloodstream infections (32%) compared with a 20% mortality rate among those without bloodstream infections.

"The study did have limitations," Howard-Anderson and Boucher cautioned, noting that "medical records were not reviewed to determine the rationale for antibiotic therapy or to determine if the antibiotic was intended to treat the DTR pathogen."

Also, the study didn't cover a period recent enough to have seen the full effects of Infectious Diseases Society of America guidelines on antimicrobial resistanceopens in a new tab or window first published in September 2020, they added.

Disclosures

The study was funded by the FDA Center for Drug Evaluation and Research.

Kadri reported no ties to industry. One study served on a clinical advisory board for Beckman Coulter.

Howard-Anderson and Boucher reported no relationships with industry.

Primary Source

Annals of Internal Medicine

Source Reference: opens in a new tab or windowStrich JR, et al "Assessing clinician utilization of next-generation antibiotics against resistant gram-negative infections in U.S. hospitals" Ann Intern Med 2024; DOI: 10.7326/M23-2309.

Secondary Source

Annals of Internal Medicine

Source Reference: opens in a new tab or windowHoward-Anderson J, Boucher HW "New antibiotics for resistant infections: What happens after approval?" Ann Intern Med 2024; DOI: 10.7326/M24-0192.

https://www.medpagetoday.com/meetingcoverage/acp/109746

'What If Fed Rate Hikes Are Actually Sparking US Economic Boom?'

 As the US economy hums along month after month, minting hundreds of thousands of new jobs and confounding experts who had warned of an imminent downturn, some on Wall Street are starting to entertain a fringe economic theory.

What if, they ask, all those interest-rate hikes the past two years are actually boosting the economy? In other words, maybe the economy isn’t booming despite higher rates but rather because of them.

It’s an idea so radical that in mainstream academic and financial circles, it borders on heresy — the sort of thing that in the past only Turkey’s populist president, Recep Tayyip Erdogan, or the most zealous disciples of Modern Monetary Theory would dare utter publicly.

But the new converts — along with a handful who confess to being at least curious about the idea — say the economic evidence is becoming impossible to ignore. By some key gauges — GDP, unemployment, corporate profits — the expansion now is as strong or even stronger than it was when the Federal Reserve first began lifting rates.

This is, the contrarians argue, because the jump in benchmark rates from 0% to over 5% is providing Americans with a significant stream of income from their bond investments and savings accounts for the first time in two decades. “The reality is people have more money,” says Kevin Muir, a former derivatives trader at RBC Capital Markets who now writes an investing newsletter called The MacroTourist.

These people — and companies — are in turn spending a big enough chunk of that new-found cash, the theory goes, to drive up demand and goose growth.

In a typical rate-hiking cycle, the additional spending from this group isn’t nearly enough to match the drop in demand from those who stop borrowing money. That’s what causes the classic Fed-induced downturn (and corresponding decline in inflation). Everyone was expecting the economy to follow that pattern and “slow precipitously,” Muir says. “I’m like no, it’s probably more balanced and might even be slightly stimulative.”

Muir and the rest of the contrarians — Greenlight Capital’s David Einhorn is the most high profile of them — say it’s different this time for a few reasons. Principal among them is the impact of exploding US budget deficits. The government’s debt has ballooned to $35 trillion, double what it was just a decade ago. That means those higher interest rates it’s now paying on the debt translate into an additional $50 billion or so flowing into the pockets of American (and foreign) bond investors each month.

That this phenomenon made rising rates stimulative, not restrictive, became obvious to the economist Warren Mosler many years ago. But as one of the most vocal advocates of Modern Monetary Theory, or MMT, his interpretation was long dismissed as the preachings of an eccentric crusader. So there’s a little sense of vindication for Mosler as he watches some of the mainstream crowd come around now. “I’ve been certainly talking about this for a very long time,” he says.

Muir readily admits to being one of those who had snickered at Mosler years ago. “I was like, you’re insane. That makes no sense.” But when the economy took off after the pandemic, he decided to take a closer look at the numbers and, to his surprise, concluded Mosler was right.

‘Really Weird’

Einhorn, one of Wall Street’s best-known value investors, came to the theory earlier than Muir, when he observed how slowly the economy was expanding even though the Fed had pinned rates at 0% after the global financial crisis. While hiking rates to extremes clearly wouldn’t help the economy — the blow to borrowers from a, say, 8% benchmark rate is just too powerful — lifting them to more moderate levels would, he figured.

Einhorn notes that US households receive income on more than $13 trillion of short-term interest-bearing assets, almost triple the $5 trillion in consumer debt, excluding mortgages, that they have to pay interest on. At today’s rates, that translates to a net gain for households of some $400 billion a year, he estimates.

“When rates get below a certain amount, they actually slow down the economy,” Einhorn said on Bloomberg’s Masters in Business podcast in February. He calls the chatter that the Fed needs to start cutting rates to avoid a slowdown “really weird.”

“Things are pretty good,” he said. “I don’t think that they’re really going to help anybody” by cutting rates.

(Rate cuts do figure prominently, it should be noted, in a corollary to the rate-hikes-lift-growth theory that another camp on Wall Street is backing. It posits that rate cuts will actually push inflation further down, not up.)

To be clear, the vast bulk of economists and investors still firmly believe in the age-old principle that higher rates choke off growth. As evidence of this, they point to rising delinquencies on credit cards and auto loans and to the fact that job growth, while still robust, has slowed.

Mark Zandi, chief economist at Moody’s Analytics, spoke for the traditionalists when he called the new theory simply “off base.” But even Zandi acknowledges that “higher rates are doing less economic damage than in times past.”

Like the converts, he cites another key factor for this resilience: Many Americans managed to lock in uber-low rates on their mortgages for 30 years during the pandemic, shielding them from much of the pain caused by rising rates. (This is a crucial difference with the rest of the world; mortgage rates rapidly adjust higher as benchmark rates rise in many developed nations.)

Bill Eigen chuckles when he recalls how so many on Wall Street were predicting catastrophe as the Fed began to ratchet up rates. “They’ll never go past 1.5% or 2%,” he intones, sarcastically, “because that will collapse the economy.”

Eigen, a bond fund manager at JPMorgan Chase, isn’t an outright proponent of the new theory. He’s more in the camp of those who sympathize with the broad contours of the idea. That stance helped him see the need to refashion his portfolio, loading it up with cash — a move that’s put him in the top 10% of active bond fund managers over the past three years.

Eigen has two side hustles outside of JPMorgan. He runs a fitness center and car repair shop. At both places, people keep spending more money, he says. Retirees, in particular. They are, he notes, perhaps the biggest beneficiaries of the higher rates.

“All of a sudden, all of this disposable income accrues to these people,” he says. “And they’re spending it.”

https://finance.yahoo.com/news/fed-rate-hikes-actually-sparking-120000966.html

Minors barred from getting weight-loss, bodybuilding pills with new NY law

 Minors will no longer be able to buy diet pills or supplements intended for muscle building or weight loss when a new state law takes effect Monday.

The legislation, which is intended to help prevent eating disorders, bans the sale of over-the-counter dietary supplements to people under age 18, though it includes exemptions for some protein powders, protein drinks and foods.

“This bill is an important measure in combating diet culture and ensuring the safety of young consumers,” Assemblymember Nily Rozic, one of the bill’s sponsors, said in a press release. Gov. Kathy Hochul signed the act into law in October.

Starting Monday, people under age 18 won’t be able to buy diet pills and bodybuilding drugs.Seksan – stock.adobe.com

Violations will be met with civil penalties of up to $500, and Attorney General Letitia James has the authority to request a warning in court if she believes there has been a violation, the trade publication Natural Products Insider reported.

Industry groups tried to thwart enforcement of the law, but received a setback Friday as a federal judge denied the Council for Responsible Nutrition’s motion for a preliminary injunction while two lawsuits challenging the law work their way through the courts, the outlet reported.

“We are in the process of reviewing the decision,” the council said in a statement provided to The Post.

The nonprofit trade group, whose members are dietary supplement manufacturers and distributors, took issue with the bill for being ambiguous; targeting marketing rather than consumption; and providing no “meaningful guidelines for compliance,” according to the complaint the council filed against James. In addition, the group says, there is no causal link between dietary supplements and eating disorders.

Detractors said there is no causal link between dietary supplements and eating disorders.AntonioDiaz – stock.adobe.com

The law “was pushed by social advocates relying on an unscientific and meritless argument that dietary supplements somehow cause eating disorders in young people, when the research shows they do not,” council CEO Steve Mister said in a release when it sought the injunction. “If we stand by and allow this law to go into effect, it won’t help young people with eating disorders, but it will stop families in the Empire State from purchasing the trusted nutrition products they use to keep their families healthy.”

Rozic and fellow bill sponsor Senator Shelley Mayer said they intended for their bill to focus on the marketing and advertising to minors “by establishing age verification guidelines for retailers and delivery sellers.”

Meanwhile, on Wednesday another federal court stayed court proceedings in a separate lawsuit filed by Natural Products Association, a nonprofit representing manufacturers and retailers of natural products, pending the outcome in the Council for Responsible Nutrition’s case.

https://nypost.com/2024/04/20/us-news/minors-barred-from-getting-weight-loss-bodybuilding-drugs-with-new-ny-law/