US says 52 million air bag inflators should be recalled over rupture threat

 U.S. auto safety regulators said on Tuesday that 52 million air bag inflators produced by auto suppliers ARC Automotive and Delphi Automotive need to be recalled because they may rupture and send dangerous metal fragments flying.

The National Highway Traffic Safety Administration (NHTSA) first demanded a voluntary recall in May, but ARC rejected it. The agency issued an initial decision on Tuesday and set a public meeting for Oct. 5 in a rare move to compel a recall.

If successful in forcing a recall, the callback would be one of the largest on record.

The inflators that NHTSA is seeking to have recalled have been used in vehicles from 2000 through early 2018 produced by 12 automakers, including General Motors, Ford Motor, Stellantis, Tesla, Toyota Motor, Hyundai, Kia, Mercedes-Benz, BMW and Volkswagen.

"Air bag inflators that rupture when commanded to deploy are plainly defective, as they both fail to protect vehicle occupants as they should, and, themselves, pose an unreasonable risk of serious injury or death," NHTSA said on Tuesday.

ARC in May rejected NHTSA's tentative conclusion that a defect existed. ARC did not immediately respond to a request for comment on Tuesday.

NHTSA said that ARC in January 2018 completed installation of devices on inflator manufacturing lines used to detect excesses of a hardened byproduct of welding known weld slag, or other debris.

The agency said it is unaware of issues in ARC inflators produced since installation of the devices. ARC said previously weld slag had not been confirmed as the root cause in the ruptures.

NHTSA said it "believes that the evidence does identify a likely cause" and added that ARC's argument on not finding a root cause "is not a reason for delaying a recall."

The agency said it is aware of seven confirmed inflator ruptures in the United States in the vehicles it seeks to have recalled, including seven injuries and one death.

https://finance.yahoo.com/news/us-says-52-million-air-172550492.html

Cellectar sees $103M private placement, pivotal data, potential 2024 product launch

Transaction led by existing investor Rosalind with participation from other new and existing healthcare-focused institutional investors

Pivotal topline data in Waldenstrom’s macroglobulinemia expected in Q4 2023 with NDA submission and potential product launch in 2024

 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced it has entered into a securities purchase agreement with certain institutional investors for a private placement financing (the “PIPE”) that is expected to result in gross proceeds of up to $102.9 million, including an initial funding of $24.5 million priced at the company’s common stock closing price on September 1, 2023 of $1.82 per share. The financing is being led by Rosalind Advisors with participation from AIGH Capital, ADAR1, Second Line, Nantahala Capital, AuGC, and other new and existing institutional investors.

“This financing with current and new investor funds of up to $102.9 million reflects the significant value of our lead asset iopofosine and R&D pipeline,” said James Caruso, president and CEO of Cellectar. “With the initial $24.5 million, we are able to fully fund all corporate activities through the completion of our pivotal trial and expected reporting of top-line data later this year. The additional tranches of financing provide ample capital through the potential accelerated approval of iopofosine and subsequent commercialization.”

https://finance.yahoo.com/news/cellectar-biosciences-announces-approximately-103-122100207.html

CDC Repeatedly Advised People With Post-Vaccination Conditions To Get More Doses

by Zachary Stieber via The Epoch Times (emphasis ours),

A network composed of experts from inside and outside the U.S. government repeatedly recommended that people who suffered adverse events following COVID-19 vaccination receive additional shots, even when the experts could not rule out the vaccines as the cause of the events, documents obtained by The Epoch Times show.

The network, the Clinical Immunization Safety Assessment (CISA) Project, is run by a doctor who has received extensive funding from pharmaceutical giants, including the top two COVID-19 vaccine manufacturers, according to other records.

In one example, CISA was presented with records showing a 63-year-old woman experienced chronic kidney disease, with symptoms including kidney swelling, after receiving a second dose of Pfizer's COVID-19 vaccine.

CISA subject matter experts (SMEs) said that the diagnosis could not be definitively confirmed without a kidney biopsy but that they still felt comfortable using a causality algorithm for the presumed diagnosis developed in part by Dr. Kathryn Edwards, CISA's principal investigator.

Applying the algorithm to the case resulted in an "indeterminate" designation, or an inability to rule out the vaccine causing the problem, in part because there was no evidence of other causes. But that inability did not stop the program from recommending additional shots.

"Weighing the potential risks of COVID-19 vaccination and the benefits of preventing COVID-19, the SMEs provided their opinion that the patient should receive future COVID-19 vaccinations," the Feb. 24, 2023, letter to the patient's doctor stated.

At the time, the effectiveness of the vaccines against symptomatic infection had been shown to start low and wane quickly, while protection against severe disease began higher but also rapidly dropped.

After the woman received her next shot, the CISA experts said, the doctor should check in on her to see if she experienced recurrent hematuria, or blood in her urine.

"Although the CDC’s subject matter experts claim to have no idea if inflammation of the kidneys in a 63-year-old woman was caused by the mRNA COVID-19 biological, they tell the attending physician to go ahead and give the woman another COVID shot. That amounts to a challenge/re-challenge experiment on a sick woman without informed consent," Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times in an email.

"Government officials admitting ignorance about a biological product’s potential side effects but directing a doctor to risk a patient’s life by continuing to inject the product into a patient, who already has suffered an injury following use of that product, is immoral," she added. "We expect and deserve government health officials to adhere to a higher professional and ethical standard of care."

Some people who experience a problem after a dose of a COVID-19 vaccine have experienced a recurrence of the problem following another dose, according to case studies and surveillance data.

Dr. Edwards, until recently of Vanderbilt University Medical Center, and the CDC did not respond to requests for comment.

Other Letters

The Epoch Times obtained, through the Freedom of Information Act, letters sent by CISA to physicians.

CISA features experts with the CDC and other institutions, including Vanderbilt University, Boston Medical Center, and Johns Hopkins University collaborating to respond to doctors who ask the program to review patient cases and provide recommendations.

"CISA provides consultations for U.S. healthcare providers with complex vaccine safety questions about their patients and conducts vaccine safety clinical research," the CDC states on its website.

The first COVID-19 vaccines were authorized and recommended in December 2020. From Dec. 1, 2020, through June 1, 2023, CISA provided 48 recommendations to doctors dealing with COVID-19 vaccines, the records show.

In 39.5 percent of the cases, CISA recommended another vaccination. In 23 percent of the cases, CISA recommended against another vaccination. In 14.5 percent of the cases, CISA said there were no reasons patients could not receive more doses. In the remaining cases, CISA advised reassessing the matter down the road or advising a patient who had not yet received a vaccine to receive a vaccine.

The recommendations for future doses came even in cases where CISA was unable to say the vaccine did not cause the adverse event.

In a letter dated May 4, 2021, CISA experts said there was "no evidence" to support non-vaccine causes for the patient's condition but that there was "no definitive known association" between the condition and Pfizer's vaccine, leading to an indeterminate designation in the causality algorithm.

While one of the experts said that in a person "with the right immunologic makeup," the vaccine "could be an initial inciting injury" causing the condition, many of the experts advised the patient to receive another dose.

The patient might want to receive Johnson & Johnson's vaccine, which uses different technology than the Pfizer and Moderna messenger RNA shots, CISA said in the letter. "Support for this guidance included that it would avoid the lipid envelope and the mRNA presentation of the antigen to this patient," they wrote.

In another letter, dated Jan. 18, 2022, CISA experts also found no evidence for non-vaccine causes for the patient's condition, which appeared after Pfizer vaccination. But they repeated the claim that there was no definitive association between the vaccine and the condition, leading to an indeterminate designation.

CISA experts "strongly felt that the risk of COVID-19 infection was higher than the potential risk from another dose of vaccine," according to the letter, and recommended a second Pfizer dose.

In a third letter, dated May 23, 2022, CISA experts said the causality algorithm resulted in an indeterminate designation "due to lack of strong evidence against a causal association." They described a "very perplexing case" and acknowledged the patient's condition was "not understood."

But CISA experts still advised the patient, who suffered an event after a Pfizer dose and had also recovered from COVID-19, to receive another shot.

"This would be especially important in light of the current surge in circulating Omicron variants," they wrote.

Small Number of Causal Determinations

A small number of cases led to the determination that the vaccination caused an adverse event.

In six instances, CISA experts determined that the event was "consistent with causal association," or caused by the vaccination, because the condition suffered by each patient was "a known possible adverse event following immunization."

In all six cases, experts recommended against additional doses while advising the doctors caring for the patients to follow up with the patients to figure out which non-COVID vaccines the patients could safely receive.

CISA experts also advised against additional COVID-19 vaccine doses in five other cases. The designations in those cases were also indeterminate, making the differences between them and those that resulted in recommendations for future doses unclear apart from several involving people who had expressed opposition to receiving more shots.

In seven other cases, CISA experts said there were no contraindications, or no reasons for not receiving at least one additional dose. The CDC has maintained a short list that currently includes just two contraindications for the COVID-19 vaccines—a history of severe allergic shock or a history of a known diagnosed allergy to a component of one of the shots.

Patients with other conditions, such as heart inflammation after COVID-19 vaccination, are generally advised to avoid additional doses, the CDC says in the list. But that is only a "precaution," not a contraindication.

CISA also advised doctors of nine of the patients to reassess future COVID-19 vaccination down the road and, in two of the cases, told doctors that patients who had not yet received a COVID vaccine could receive one.

https://www.zerohedge.com/political/cdc-repeatedly-advised-people-post-vaccination-conditions-get-more-doses

People Rarely Transmit COVID-19 Before Experiencing Symptoms: Lancet

by Tom Ozimek via The Epoch Times (emphasis ours),

In a blow to the COVID-19 "silent spreader" narrative that has been used to push for universal masking, including controversially among schoolchildren, a recent study published in The Lancet suggests that people who are non-symptomatic rarely have the ability to infect others.

Silent transmission is the idea that those who are infected with COVID-19 but show no symptoms can still spread the virus to other people.

While all relevant studies show that presymptomatic and asymptomatic "silent spreaders" account for some proportion of infections in other people, the degree of silent transmission is less clear.

A number of early studies—in some cases affected by limitations that may have led to their proportion of presymptomatic transmission to be "artifactually inflated"—suggested that silent transmission accounted for around half of secondary infections, or even more.

The early studies led public health authorities to argue that everyone should wear a mask at all times when out in public or crowded places. This, in turn, helped drive draconian universal masking policies, including in schools, in a bid to reduce the spread of COVID-19.

For instance, Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases (NIAID), initially discouraged universal mask-wearing early in the pandemic but later did a U-turn.

Initially, “we didn’t realize the extent of asymptotic spread," Dr. Fauci said in July 2020, adding that later, "we fully realized that there are a lot of people who are asymptomatic who are spreading infection."

"So it became clear that we absolutely should be wearing masks consistently,” Dr. Fauci said at the time.

But new research calls into question the significance of the threat of silent transmission, which comes as COVID-19 cases are on the rise in America, driving what some are calling a renewed pandemic "hysteria" and calls for a fresh round of restrictions, including mask mandates.

'Very Few Emissions' Before Symptom Onset

The new study, published in the August issue of The Lancet's Microbe journal, shows that people who are sick with COVID-19 but don't show any symptoms have a limited ability to spread the virus to other people.

Participants in the British study, which was carried out by researchers at Imperial College London, were unvaccinated healthy adults aged 18-30 who were intentionally infected with COVID-19.

The subjects were monitored under controlled circumstances while self-reporting symptoms three times per day, and researchers collected nose and throat swabs from them daily, checking for the presence of the virus.

The researchers also tested the inside of masks worn by the participants, checked their hands, and examined the air and surfaces of rooms that the subjects were kept in for a minimum of 14 days.

Ultimately, the researchers found that less than 10 percent of the viral emissions from infected participants took place before the first symptoms emerged.

"Very few emissions occurred before the first reported symptom (7%) and hardly any before the first positive lateral flow antigen test (2%)," the authors of the study wrote.

The new study—which takes the form of a rigorous, controlled "challenge study" rather than the earlier modeling studies that relied on subjective inputs and assumptions of researchers—contradicts earlier research that set the tone for much of the prevailing narrative. That early research appears to have inflated the perceived threat of presymptomatic spread.

The latest study, suggesting that silent transmission is far less significant, comes amid a growing drumbeat of alarm as COVID-19 cases, hospitalizations, and deaths are on the rise—along with calls in some circles for renewed restrictions.

By contrast, many are calling for cool heads to prevail—or are urging civil disobedience if lockdowns or other mandates are reimposed.

'Artifactually Inflated'?

Some early studies, such as one published in August 2020 called "Temporal Dynamics In Viral Shedding and Transmissibility of COVID-19," suggested that people who were presymptomatic or asymptomatic accounted for a large proportion of secondary infections.

This particular study estimated that 44 percent of secondary cases were infected during the presymptomatic stage, while concluding that "disease control measures should be adjusted to account for probably substantial presymptomatic transmission."

The authors of the study admitted that it had several limitations, however, including potential "recall bias" that may have tended towards a delay in recognizing first symptoms.

"The incubation period would have been overestimated, and thus the proportion of presymptomatic transmission artifactually inflated," meaning that the study may have exaggerated the proportion of people who spread the virus before showing symptoms, they said.

Another study from July 2020 called "The Implications of Silent Transmission for the Control of COVID-19 Outbreaks" went even further, suggesting that people were most infectious during the presymptomatic phase and concluding that silent transmission was the "primary driver of COVID-19 outbreaks and underscore the need for mitigation strategies, such as contact tracing, that detect and isolate infectious individuals prior to the onset of symptoms."

That study relied on a range of assumptions and models, with different presymptomatic, asymptomatic, and symptomatic transmission rates calculated based on a complex mathematical model from another study.

Findings from earlier studies like the ones cited above led public health officials to argue that silent spreaders were a big factor in COVID-19 transmission and so to recommend that everyone should mask up

https://www.zerohedge.com/medical/people-rarely-transmit-covid-19-experiencing-symptoms-lancet-study

Can a Decrease in Dopamine Lead to Binge Eating?

 In medical school, we were repeatedly advised that there is both a science and an art to the practice of medicine. In these days of doc-in-a-box online consultations for obesity, it's tempting to think that there's a one-size-fits-all purely scientific approach for these new weight loss medications. Yet, for every nine patients who lose weight seemingly effortlessly on this class of medication, there is always one whose body stubbornly refuses to submit.

Caroline Messer, MD

Adam is a 58-year-old man who came to me last month because he was having difficulty losing weight. Over the past 20 years, he'd been steadily gaining weight and now, technically has morbid obesity (a term which should arguably be obsolete). His weight gain is complicated by high blood pressure, high cholesterol, and obstructive sleep apnea. His sleep apnea has caused such profound exhaustion that he no longer has the energy to work out. He also has significant attention-deficit/hyperactivity disorder (ADHD) which has been left untreated due to his ability to white-knuckle it through his many daily meetings and calls. A married father of three, he is a successful portfolio manager at a high-yield bond fund.

Adam tends to eat minimally during the day, thereby baffling his colleagues with the stark contrast between his minimal caloric intake and his large belly. However, when he returns from work late at night (kids safely tucked into bed), the floodgates open. He reports polishing off pints of ice cream, scarfing down bags of cookies, inhaling trays of brownies. No carbohydrate is off limits to him once he steps off the Metro North train and crosses the threshold from work to home. 

Does Adam simply lack the desire or common-sense willpower to make the necessary changes in his lifestyle or is there something more complicated at play?

I would argue that Adam's ADHD triggered a binge-eating disorder (BED) that festered unchecked over the past 20 years. Patients with BED typically eat massive quantities of food over short periods of time — often when they're not even hungry! Adam admitted that he would generally continue to eat well after feeling stuffed to the brim. It is well known that ADHD is a leading cause of binge-eating tendencies. So, what is the link between these two seemingly unrelated disorders?

The answer probably lies with dopamine, a neurotransmitter produced in the reward centers of the brain which regulates how people experience pleasure and control impulses. We believe that people with ADHD have low levels of dopamine (it's actually a bit more complicated, but this is the general idea). These low levels of dopamine lead people to self-medicate with sugars, salt, and fats to increase dopamine levels.

Lisdexamfetamine (Vyvanse) is a US Food and Drug Administration–approved treatment option for both ADHD and binge eating. It raises the levels of dopamine (as well as norepinephrine) in the brain's reward center. Often, the strong urge to binge subsides rapidly once ADHD is properly treated.

Rather than starting Adam on a semaglutide or similar agent, I opted to start him on lisdexamfetamine. When I spoke to him 1 week later, he confided that the world suddenly shifted into focus, and he was able to plan his meals throughout the day and resist the urge to binge late at night.

I may eventually add a semaglutide-like medication if his weight loss plateaus, but for now, I will focus on raising his dopamine levels to tackle the underlying cause of his weight gain.

Caroline Messer, MD

Clinical Assistant Professor, Mount Sinai School of Medicine; Associate Professor, Hofstra School of Medicine, New York, NY

Disclosure: Caroline Messer, MD, has disclosed no relevant financial relationships.

https://www.medscape.com/viewarticle/995987

Osteoarthritis Cases Projected to Balloon Over Next 30 Years

 Nearly 600 million people worldwide (7.6% of the world's population) have osteoarthritis, and numbers are expected to rise starkly by 2050, especially knee/hip disease.

METHODOLOGY:

• Researchers estimated the prevalence of osteoarthritis in 204 countries and territories from 1990 to 2020 and projected prevalence levels for the year 2050.

• Population-based surveys offered data from 26 countries for knee osteoarthritis, 23 countries for hip osteoarthritis, and 42 countries for hand osteoarthritis. Researchers used US insurance claims to estimate prevalence for other osteoarthritis types.

• Similar analyses were conducted in 2010 and 2017.

TAKEAWAY:

• Osteoarthritis cases worldwide have grown by an estimated 132.2% since 1990. Population growth and aging were identified as major contributing factors.

• In 2020, an estimated 595 million people had osteoarthritis. From 2020 to 2050, cases of osteoarthritis in the knee are expected to grow by 74.9%, in the hand by 48.6%, in the hip by 78.6%, and in other locations by 95.1%.  

• Years lived with disability (age-standardized rate) grew from an estimated 233 per 100,000 in 1990 to 255 per 100,000 in 2020, an increase of 9.5%.

• High body mass index contributed to 20.4% of cases.

IN PRACTICE:

In "a major challenge to health systems," osteoarthritis may affect nearly
1 billion people in 2050.

SOURCE:

The Global Burden of Disease 2021 Osteoarthritis Collaborators, led by Jaimie D. Steinmetz, PhD, MSc, of the Institute for Health Metrics and Evaluation, Seattle, Washington, conducted the study, which was published in the September 2023 issue of The Lancet Rheumatology.

LIMITATIONS:

Limited data, heavy reliance on US insurance data, and other factors may have skewed the results.

DISCLOSURES:

The study was supported by the Bill & Melinda Gates Foundation, the Institute of Bone and Joint Research, and the Global Alliance for Musculoskeletal Health. Multiple authors report various disclosures. The full list can be found with the original article.

https://www.medscape.com/viewarticle/996110

Corrupt Billionaire Behind Zelensky's Rise To Fame & Power Arrested

 With an estimated fortune of just under $1.7 billion, Ihor Kolomoisky is among Ukraine's top five richest citizens. Over the weekend he was arrested by Ukraine authorities on an array of fraud and money laundering charges, at a sensitive moment the government is trying to show the world it can tackle deeply rooted corruption.

A Saturday statement from the Security Service of Ukraine (SBU) said that the billionaire, referred to as the "de facto owner of a large financial and industrial group" – had allegedly tried to launder over 500 million Ukrainian hryvnia ($13.5 million) by "transferring it abroad, while using the infrastructure of banking institutions controlled by him."

A Kyiv court has ordered him to pretrial detention for two months amid an ongoing investigation, with bail having been set at a whopping $14 million.

Importantly, The New York Times in its Tuesday coverage of Kolomoisky's arrest highlighted that he was an early major backer of now President Volodymyr Zelensky who had a hand in bringing him to power. He's also widely believed to have funded extremist private militia armies at various times.

Writes the NY Times: "His business interests have included oil and banking, and he was once considered a patron of Mr. Zelensky, a former comedian whose popular shows were broadcast on Mr. Kolomoisky’s television channel before he successfully ran for the presidency."

And further very revealing details are included in the Times report as follows:

Suspicions of corruption and embezzlement have dogged Mr. Kolomoisky for years. In 2017, he left Ukraine for Switzerland and Israel after the government of then-President Petro O. Poroshenko seized a bank he co-owned and accused him of a large-scale fraud that threatened to destabilize Ukraine’s economy.

He returned in 2019 after Mr. Zelensky’s defeat of Mr. Poroshenko, raising fears that his ties to the new president would help him regain his economic and political clout.

So naturally, Western mainstream press is now presenting this as a "big fish" prosecution showing Zelensky is getting "tough" and finally going gloves-off on exposing long-standing corruption.

The timing is also interesting given Zelensky just sacked his own defense minister, an announcement which came the same weekend as billionaire Kolomoisky's arrest. "This week, parliament will be asked to make a personnel decision … I have decided to replace the minister of defense of Ukraine. Oleksii Reznikov has gone through more than 550 days of full-scale war," Zelensky said over the weekend. 

And guess who was degrees of separation away from Hunter Biden, related to shady Bursima relationships? "Besides being connected through the Burisma energy giant, Hunter Biden did business with Igor Kolomoisky's bank," one prior report reads.

As for the dismissed defense minister, Reznikov was at the center of an anti-graft probe into the military's paying inflated prices for imported items, sometimes at triple or more the cost, the profits of which are believed to have lined the pockets of top military officials. There's also the recent recruiting scandal, where top military recruiters were given large bribes to allow individuals to avoid conscription.

In the backdrop is Ukraine's application to join the European Union. Of course, the fact that Ukraine tops the list of Europe's most corrupt societies will remain a major hurdle likely for years to come.

Russian media has meanwhile pointed out that Kolomoysky has personally entered the political arena at times, and that his money has hugely impacted the country in ways known and unknown:

Kolomoysky burst on to the political scene in 2014, when he was appointed governor of the southeastern Dnepropetrovsk Region following a Western-backed coup in Kiev. A year later, however, he was dismissed from his post over a conflict with then-Ukrainian President Pyotr Poroshenko amid a struggle for control of Ukrnafta and state-owned oil pipeline operator Ukrtransnafta.

In 2016, Ukrainian authorities also nationalized Kolomoysky’s PrivatBank, after declaring it a major threat to the country’s financial system, following allegations of large-scale fraud.

Kolomoysky is also widely considered to have played a major role in the rise to power of President Vladimir Zelensky. Before launching his political campaign in 2019, Zelensky was a comedian, whose show was hosted by a Kolomoysky-controlled media holding. The magnate himself said he “wanted” Zelensky to become president, but denied close contacts with him.

In this particular case it's very likely Washington has brought pressure to bear on Kyiv, given that as far back as 2021 the US State Dept. sanctioned Kolomoysky and his family members. A US statement at the time said he was engaged "in corrupt acts that undermined rule of law and the Ukrainian public’s faith in their government’s democratic institutions."

He may have at one point even been stripped of his Ukrainian passport, but he's personally dismissed these reports as well as the widespread allegations of corruption as being "nonsense" and without merit.

* * *

Perhaps this is why it was easy for Zelensky to now (after all these years of "open" corruption) deliver him to the courts? Starting in 2019 Kolomoisky began making some pro-Moscow statements, in a major reverse-course...

Ukraine should give up on the West and go back into Russia’s fold, influential Ukrainian billionaire Ihor Kolomoisky said in an interview with The New York Times Wednesday.

Kolomoisky’s business ties to Ukrainian President Volodymyr Zelenskiy have been under heavy scrutiny since the start of the former comedian’s election campaign this year. Both men have rejected suggestions that Kolomoisky has behind-the-scenes influence over Zelenskiy. 

The Moscow Times picked out quotes from Kolomoisky’s emotional and profanity-laced interview that The New York Times says marks a “remarkable change of heart” for Russia’s former opponent.

Meanwhile...

https://www.zerohedge.com/geopolitical/corrupt-billionaire-behind-zelenskys-rise-fame-power-arrested