'RSV Vaccine Benefits Probably Outweigh Small Neurologic Risk, CDC Says'

 The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC's Advisory Committee on Immunization Practices (ACIP) reaffirmed.

In a presentation on the second day of the ACIP's 2-day meeting, Amadea Britton, MD, of the CDC's RSV adult vaccination work group in Atlanta, noted that a small number of cases of Guillain-Barre syndrome had been observed in the clinical trials for both FDA-approved RSV prefusion F protein vaccines, but that it remained unclear whether those cases were actually caused by RSV vaccination or just chance occurrences.

At the time of the committee's initial recommendationopens in a new tab or window for RSV vaccination in June 2023, the ACIP concluded that the estimated benefits of RSV vaccination outweighed potential risks but recommended incorporating shared decision-making into individualized risk-benefit discussions. The first-ever RSV vaccineopens in a new tab or window (Arexvy) got the FDA greenlight in May 2023 for adults ages 60 and older, followed by approval of a second RSV vaccineopens in a new tab or window (Abrysvo) later that month for the same population.

Michael Melgar, MD, also of the CDC, presented an analysis of FDA active surveillance data gathered from Medicare beneficiaries ages 65 years and older from May to December 2023. There were a potential 10 GBS cases (95% CI 2-18) per 1 million Arexvy doses administered and a potential 25 GBS cases (95% CI 7-43) per million Abrysvo doses. The historical GBS background rate from 2022 suggested five GBS cases per 1 million would have been expected, he said while cautioning that the historical background rate might not be a reliable comparison.

Britton seconded that cautious stance, pointing to the flu vaccine for context in which there's an additional one or two cases of GBS per million doses but a much higher risk of GBS from the flu itself.

"Due to uncertainty and limitations in these early data, there is currently insufficient evidence to confirm whether RSV vaccination is associated with increased risk for GBS in older adults, or to estimate the magnitude of any increase in GBS risk after RSV vaccination," she said. "Any increase in potential risk of GBS should be placed in the context of the benefits of RSV vaccination."

As to the benefits of RSV vaccination, Melgar and colleagues projected that over the course of two RSV seasons, every 1 million doses administered in the older adult population would prevent an estimated 23,000-26,000 outpatient visits, 2,200-2,700 hospitalizations, 420-550 ICU admissions, and 120-140 in-hospital deaths.

However, uptake of the RSV vaccines has been low. Only about 22% of adults ages 60 and olderopens in a new tab or window had received an RSV vaccine through February of this year, according to the CDC.

"Based on this review of currently available data, the [vaccination] work group continues to believe that the estimated benefits of RSV vaccination outweigh potential risks when vaccination is implemented using the current recommendation," Britton said. Adults who are 60 and older with chronic medical conditions such as chronic lung diseases, heart failure, immune compromise, those of more advanced age, and those living in long-term care facilities are at greater risk for severe RSV disease and most likely to benefit from vaccination, she noted.

However, the group acknowledged that the benefit from RSV vaccination may be lower for people ages 60 or older who do not have any chronic medical conditions and who do not live in long-term care facilities.

https://www.medpagetoday.com/infectiousdisease/vaccines/108969

Xylazine-Laced Fentanyl Overdose: 'Make Sure They're Breathing'

 With rising reports of the veterinary sedative xylazine -- also known as "tranq" -- being mixed in with illicit fentanyl, physicians should be aware that the clinical endpoint for "reversing" an overdose should be that the person is breathing, experts said during a CDC call for clinicians.

"The idea that people have to wake up to be successful is a bit of a misunderstanding," Lewis Nelson, MD, chair of emergency medicine at Rutgers New Jersey Medical School in Newark, said during a CDC Clinician Outreach and Communication Activity (COCA) call on Thursday hosted by the agency's National Center for Injury Prevention and Control (NCIPC).

"We don't really need people to wake up. We need them to breathe," he said. "If they have a combination overdose, it may be the xylazine that's causing sedation. But if they're breathing, they're going to do fine."

It's possible to administer too much of the opioid overdose reversal agent naloxone (Narcan) to these patients, leading to opioid withdrawal, Nelson noted.

"It's better than dying, but most of these people don't die," he said. "If we're concerned about somebody not waking up because we're looking at wakefulness as an endpoint, instead of breathing, it can lead to adverse outcomes."

In a similar vein, there's not really a need to administer a xylazine reversal agent. One does exist, in veterinary medicine at least: atipamezole. It is not approved for use in humans, he said, and "there's probably not a need to invest a lot of resources in development of this drug for humans."

Yohimbine -- a botanical extract of the bark of a west African evergreen tree historically used to enhance sexual performance -- is also a xylazine reversal agent, but again, one that is not needed, he added.

There is "rarely" such a thing as a naloxone-resistant overdose, as naloxone is "very good at reversing fentanyl," Nelson said. "Remember, we're really not treating xylazine here, we're treating the opioid."

While fentanyl may be a potent opioid agonist, it's not really potency that matters in reversing an overdose -- it's affinity, Nelson explained, noting that naloxone has a much higher affinity for opioid receptors than fentanyl or other fentanyl analogs.

"Naloxone should have no problem reversing fentanyl or its analogs," he said. "It will not reverse xylazine, which is why patients may appear to be naloxone-resistant."

But as long as they are breathing, they will be fine, since they are likely just experiencing the sedative effects of the xylazine, he reiterated.

Though data on xylazine's respiratory depressant effects in humans are sparse, Nelson noted three case reports in the literature of people attempting to use xylazine for self-harm. All show survival and "the sum of this really suggests xylazine probably doesn't have tremendous respiratory depressant effects in humans."

Josh Schier, MD, MPH, a captain in the U.S. Public Health Service and a senior medical officer in CDC's NCIPC, reviewed the current data on xylazine epidemiology in the U.S., pointing to a June 2023 publicationopens in a new tab or window in CDC's Morbidity & Mortality Weekly Report showing a 276% increase in fentanyl-involved deaths where xylazine was detected from 2019 to 2022.

That said, recent data from the National Forensic Laboratory Information System reported in September 2023 showed an apparent downturn in xylazine reports, and data from the Maryland Rapid Analysis of Drugs program also showed a recent reporting drop in xylazine in all samples tested.

Schier noted that there are many caveats, including possible reporting delays or transient drop-offs, that may account for these recent trends. "Only time will tell," he said.

Rachel Wightman, MD, of the Alpert Medical School at Brown University in Providence, Rhode Island, who is also a consultant medical director at the Rhode Island Department of Health, discussed strategies for managing xylazine-laced fentanyl in the community, including surveillance testing, public education campaigns, and harm reduction initiatives.

Xylazine is an alpha-2 adrenergic receptor agonist that was originally developed in the 1960s as an antihypertensive but was quickly shelved because of its strong sedative effects. Its use in the illicit drug supply was first reported in drug samples from Puerto Rico in the early 2000s, Schier said. It's unclear why it's been increasingly added to fentanyl but it could have a synergistic psychoactive effect or it could prolong the short-acting effects of illicitly manufactured fentanyl, he noted.

https://www.medpagetoday.com/publichealthpolicy/publichealth/108970

Y-mAbs: Strong Revenue Growth

 

• Net Product Revenues: Q4 net product revenues surged to $23.4 million, a 42% increase YoY, with FY 2023 revenues reaching $84.3 million, marking a 71% growth.

• Operating Expenses: Operating expenses saw a reduction, with R&D expenses decreasing by 32% in Q4 and 41% for the full year, and SG&A expenses down by 26% for FY 2023.

• Net Loss: Q4 net loss was $1.0 million, a significant improvement from the net loss of $95.6 million for FY 2022.

• Cash Position: Cash and cash equivalents stood at $78.6 million as of December 31, 2023, with an anticipated cash runway extending into 2027.

• 2024 Financial Guidance: Projected DANYELZA net product revenues of $95 million to $100 million and operating expenses between $115 million and $120 million.

On February 29, 2024, Y-mAbs Therapeutics Inc (NASDAQ:YMAB), a commercial-stage biopharmaceutical company, released its 8-K filing, detailing its financial results for the fourth quarter and full year of 2023. The company, known for its development and commercialization of novel cancer therapies, including its flagship product DANYELZA, reported significant revenue growth and a solid cash position, affirming its financial guidance for the upcoming year.

Company Overview

Y-mAbs Therapeutics Inc is at the forefront of cancer treatment innovation, focusing on antibody-based therapeutics. With DANYELZA as its first FDA-approved product, the company has established a strong presence in the United States and is expanding its reach globally through strategic sublicenses and distribution agreements.

Financial Performance and Challenges

The company's financial results reflect a robust increase in DANYELZA net product revenues, with a 42% year-over-year growth for the fourth quarter and a 71% increase for the full year. This growth is a testament to the company's commercial success and the increasing adoption of DANYELZA in treatment centers across the U.S. Despite this success, the company faces the challenge of sustaining its growth trajectory and managing operating expenses to ensure long-term profitability.

https://finance.yahoo.com/news/y-mabs-therapeutics-inc-ymab-213759783.html

Why Didn't "Healthy, Robust" Biden Take A Cognitive Test During Medical Exam?

 by Paul Joseph Watson via Modernity.news,

Questions are mounting as to why Joe Biden was not given a cognitive test during his medical examination yesterday.

Biden underwent a physical exam at Walter Reed National Military Medical Center yesterday, with Dr Kevin O’Connor asserting there were no new concerns about Biden’s health.

Mr Biden “is a healthy, active, robust, 81-year-old male who remains fit to successfully execute the duties of the presidency,” wrote O’Connor in his report.

However, the exam did not include a cognitive test despite innumerable examples of Biden getting lost on stage, thinking he had talked to dead political leaders and falling prey to embarrassing verbal gaffes in recent months.

White House press secretary Karine Jean-Pierre ludicrously said Dr O’Connor and Biden’s neurologist “don’t believe he needs” a cognitive exam, and added: “He passes a cognitive test every day, every day as he moves from one topic to another topic, understanding the granular level of these topics.”

Before the results were released, which contained no information whatsoever about Biden’s cognitive health, Dr. Marc Siegel said that the president’s mental acuity should have been the top priority.

“What I’m concerned about and what the American public is concerned about is what are they gonna say about his neurological exam,” said Dr. Siegel, drawing attention to Biden’s “stiffened gait”.

“To a lot of neurologists who I have talked to, it’s a shuffling gate that looks like it could come from some kind of neurological problem,” he added.

“What does the MRI of the brain show?” asked Siegel, adding that there have been “a lot of lapses going on that would want us to see an MRI of the brain.”

Siegel said that a lot of people who showed as much difficulty with walking as Biden would be using a cane.

“If he falls on his head on blood thinners, that’s an enormous problem, it’s not just an 81-year-old falling, it’s an 81-year-old falling on blood thinners,” noted the doctor.

As we previously highlighted, after Special counsel Robert Hur concluded in his report that Biden did not remember when he was vice-president or within “several years” when his son Beau died, Canadian neurologist Dr. Ziad Nasreddine, who invented the ‘gold standard’ of cognitive tests, told the New York Post that all ageing politicians should take it.

Democrats are panicking to replace Biden after he twice claimed to have recently spoken to political leaders who have been dead for decades.

The White House tried to dismiss the mistake as “normal,” but one ally told the Telegraph that his recent press conference performance was “the worst day” of Biden’s entire presidency.

https://www.zerohedge.com/political/why-didnt-healthy-robust-biden-take-cognitive-test-during-medical-exam

Healthcare providers hit by frozen payments in ransomware outage

 Healthcare providers across the United States are struggling to get paid following the week-long ransomware outage at a key tech unit of UnitedHealth Group, with some smaller providers saying they are already running low on cash.

Large hospital chains are also locked out of processing payments with some absorbing the upfront costs of being unable to collect, according to the American Hospital Association (AHA), which represents nearly 5,000 hospitals, healthcare systems, networks and other providers.

Reuters could not gauge the full magnitude of the problem, but six small businesses across the United States - five therapists and one laboratory - said they were unable to process claims and were racking up thousands of dollars in overdue payments.

The problems began last week after hackers gained access to UnitedHealth's Change Healthcare unit, a vital lynchpin in the complex U.S. system for making and clearing insurance claims. It also affected electronic pharmacy refills and insurance transactions, particularly among independents, with some reverting to paper transactions.

"We are 100 percent down when it comes to billing right now," said Phil Seubring, legal director at Forensic Fluids, a Kalamazoo, Michigan lab that does drug testing for doctors' offices.

"I'm not getting paid," said Jenna Wolfson, a Felton, California-based clinical social worker who provides therapy to about 30 clients a week. She said she had about $4,000 in claims in limbo. "This could be catastrophic for me and other small business mental health practitioners."

The early impact may hit small offices harder, but providers of all sizes will feel the strain if the outage persists, John Riggi, AHA cybersecurity adviser and a former section chief for the FBI's cyber division, told Reuters.

"Larger, more well-resourced hospitals that have alternate technologies and sufficient cash reserves will be able to sustain the outage initially and on a longer basis," he said.

https://finance.yahoo.com/news/healthcare-providers-hit-frozen-payments-110940931.html

NYCB Re-Crashes After Finding "Material Weaknesses" In Internal Controls, Delays Filing

 Just when you thought it was safe to go back in the regional bank waters...

Remember New York Community Bank - the embattled bank that made the surprise decision to slash its dividend to stockpile cash (in case commercial real estate loans go bad) amid mounting pressure from a top US watchdog (read here, here, and here)?

Well theeeyyyy're back!

According to a regulatory filing this evening, NYCB disclosed that it identified material weaknesses in its internal controls related to internal loan review as part of an assessment.

“Management identified material weaknesses in the company’s internal controls related to internal loan review, resulting from ineffective oversight, risk assessment and monitoring activities,” the bank said in the filing.

Due to this, the bank will delay its annual report.

"'NYCB' has determined that it is unable to file, without unreasonable effort or expense, its Annual Report on Form 10-K for the fiscal year ended December 31, 2023

NYCB also took a $2.4 BN hit to 4Q and annual net (loss) income, as GAAP accounting required a "goodwill impairment" charge for the quarter and fiscal year ended Dec. 31, 2023.

Additionally, Alessandro DiNello will be chief executive officer, succeeding Thomas Cangemi, it said in a statement late Thursday.

DiNello was appointed as executive chairman earlier this month to help the bank improve its operations. He joined the company following its acquisition of Flagstar Bancorp Inc. in December 2022. He had been Flagstar’s president and CEO.

Cangemi remains on the board.

NYCB Shares are down over 10% in the after-market, having stabilized (albeit at lower levels) after early Feb's debacle (that wiped over 50% of the bank's value away)...

Full filing details below:

On January 31, 2024, NYCB filed a Current Report on Form 8-K furnishing under Items 2.02 and 9.01 the Company’s press release announcing its unaudited financial results for the fourth quarter and fiscal year ended December 31, 2023 (the “Original Filing”). The full text of the press release was included as Exhibit 99.1 to the Original Filing.

On February 29, 2024, NYCB filed with the Securities and Exchange Commission (the “SEC”) an Amendment (the “Amendment”) to the Original Filing to reflect, among other things, (a) an adjustment related to a goodwill impairment with respect to 2007 and prior transactions, as more fully described therein, (b) certain measurement period adjustments impacting the Company’s bargain purchase gain from the Company’s acquisition of certain assets and liabilities of the former Signature Bank through a Federal Deposit Insurance Corporation facilitated transaction and (c) an adjustment for a type 1 subsequent event (as more fully described in the Amendment). Each of these adjustments were identified by NYCB’s management after the date of the Original Filing and as part of the Company’s customary procedures to finalize its financial statements for inclusion in its Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Form 10-K”).

Separately, as part of management’s assessment of the Company’s internal controls, management identified material weaknesses in the Company’s internal controls related to internal loan review, resulting from ineffective oversight, risk assessment and monitoring activities. Although assessment of the Company’s internal controls is not yet complete, the Company expects to disclose in the 2023 Form 10-K that its disclosure controls and procedures and internal control over financial reporting were not effective as of December 31, 2023. The Company’s remediation plan with respect to such material weaknesses is expected to be described in the 2023 Form 10-K.

The Company has been working diligently to finalize the 2023 Form 10-K; however, the Company must complete its work related to the evaluation and planning for remediation of the material weaknesses described above and other items included in the Amendment. Accordingly, the Company has determined that it is unable to file, without unreasonable effort or expense, the 2023 Form 10-K by the prescribed due date.

The Company expects to file its 2023 Form 10-K within the fifteen calendar day grace period provided by Form 12b-25. The Company does not currently anticipate that its statement of operations contained in the 2023 Form 10-K will differ materially from those reported for the full fiscal year ended December 31, 2023, in the Amendment dated February 29, 2024.

Does anyone trust any of the valuations in the loan book after this?

https://www.zerohedge.com/markets/nycb-re-crashes-after-finding-material-weaknesses-internal-controls-delays-filing

Biden Now Says No Gaza Ceasefire Soon, Contradicting His "By Monday" Remarks

 The sitting US Commander-in-Chief seems to sometimes just make stuff up on the fly, based on apparently no real information, but just because it sounds good in the moment. Here's what he said at the start of the week... Biden while in an ice cream shop Tuesday in New York with Seth Meyers was asked by a reporter when he thought a ceasefire could begin, to which he answered he hoped a truce would be implemented within days. "Well, I hope by the beginning of the weekend, by the end of the weekend," he said. And that's when offered Monday as the day the warring sides will reach a ceasefire. "My national security adviser tells me that we’re close. We’re close. We’re not done yet. My hope is, by next Monday, we’ll have a ceasefire."

As we reported earlier, Israeli officials and even Hamas seemed to have no idea what he was talking about. Both sides issued statements concerning the Qatar-mediated negotiations process saying they are a long way away from achieving any kind of truce. Biden's somewhat off the cuff remarks likely even raised eyebrows among his own officials, given the totality of reporting over the last several days has been negative on the prospect of an imminent peace deal and hostage/prisoner swap. 

And now by week's end, on Thursday Biden issued the opposite assessment, and even pinpointed his own prior "Monday" remarks. Apparently some his own negotiators got back to him (including likely the CIA Director William Burns, who has been key in the talks) and told him they're not even close. After all, PM Netanyahu has been hammering the "delusional" Hamas demands, something he's just repeated again on Thursday. Biden now says: "I was on the telephone with the people in the region. Probably not by Monday."

https://www.zerohedge.com/political/biden-now-says-no-gaza-ceasefire-soon-after-his-own-monday-remarks