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Wednesday, September 27, 2023

States would be forced to recover staggering $11B in food stamp overpayments under proposed law

 A proposed law would force states to recover billions of dollars from waste and fraud in the federal food stamps program that were ignored during the COVID-19 pandemic.

A staggering $11 billion in overpayments were delivered to recipients in the Supplemental Nutrition Assistance Program (SNAP), also known as the food stamps program, according to 2022 federal data — up from $3.4 billion in 2019.

Nearly 80% of improper payments were the result of errors made by the state agency.

But the US Department of Agriculture and states that administer food stamp aid to recipients all but abandoned clawing back the funds since 2019 — before the COVID-19 pandemic, said Sen. Joni Ernst (R-Iowa).

The feds exempted states from even reporting data on overpayments and error rates in 2020 and 2021 during the outbreak.

The overpayment rate skyrocketed nationally from 6.18% in 2018 to 9.84% in fiscal year 2022.

In New York, the overpayment rate was even higher — surging from 5.9% in 2019 to 10.35% in 2022.

Ernst said the true cost is unknown because overpayment errors totaling $54 or less per recipient are exempt from collection.

In New York the overpayment rate went from 5.9% in 2019 to 10.35% in 2022.
Christopher Sadowski

The senator’s bill would require states to recover all the overpayments to recipients and pay the federal government what it owes.

The bill also requires that all SNAP payment errors be reported, regardless of the amount.

Ernst even suggested states may be pocketing some of the funds.

“Families across the country are going hungry while bureaucrats are jumping the line to gobble up SNAP dollars, either as a meal ticket to beef up state budgets or a self-serve buffet of benefits for themselves or others who do not qualify,” Ernst told The Post.

“I’m snapping back! It’s time for states at fault to pay the piper and eat the costs of their taxpayer waste. Instead of over-serving bureaucrats, let’s end the waste and set a place at the table for hungry families.”

Food stamp spending and enrollment exploded amid the pandemic.

Ernst said that it is time for “states at fault to pay the piper and eat the costs of their taxpayer waste.”
REUTERS/Evelyn Hockstein

In 2022, there were more than 41 million Americans on food stamps, compared to about 35 million people in 2019.

During the same four-year period, spending on food stamps grew to a record-high $119.5 billion, up from $60 billion in 2019. 

Food stamp spending nearly doubled, despite only 6 million additional enrollees, an analysis by the Foundation for Government Accountability said.

Monthly food stamp benefits in New York are a maximum of $740 for a family of three, $939 for a family of four, $1,116 for a family of five and $1,339 for a family of six. 

“Food stamp fraud costs taxpayers millions and diverts resources from the truly needy. Congress should pass basic program integrity measures to prevent fraud before it happens,” the FGA said.

New York has had its share of people ripping off the food stamp program, including government workers.

A law proposed by Sen. Joni Ernst would require states to recover $11 billion of waste in the federal food stamps program that were ignored during the COVID-19 pandemic.
Christopher Sadowski

An employee of the city’s Human Resources Administration was nabbed in 2017 for using inside knowledge to create fake accounts and stole more than $225,000 in food stamps and other benefits over seven years, the state inspector general reported.

Two city HRA workers were also busted in 2015 after exploiting flaws in the city’s welfare system to swipe $2.1 million worth of food stamps and rental subsidies — and then spent $120,000 on Red Bull, authorities at the time said.

The Department of Agriculture declined to comment on Ernst’s SNAP accountability bill.

But in a June statement, it acknowledged that states were not required to issue overpayments or error rates in the food stamp program in 2020 and 2021 during the pandemic.

“USDA is committed to supporting states in improving payment accuracy in SNAP to ensure the program effectively and efficiently serves those who need it and promotes good stewardship of taxpayer dollars,” the agency said.

“We are doubling down to work with state partners to find ways to decrease payment errors and tackle the issues aggressively at their root cause. Together, we will continue to move toward a stronger, efficient, more modern future for SNAP and those it serves.”

New York Gov. Kathy Hochul’s office had no immediate comment.

https://nypost.com/2023/09/26/states-could-be-made-to-recover-11b-in-food-stamp-overpayments/

Tuesday, September 26, 2023

Volkswagen to temporarily cut production of two EV models due to weaker demand

 Volkswagen will suspend production of ID.3 and Cupra Born electric cars at its Zwickau and Dresden plants in Germany in the first two weeks of October due to weaker demand, a spokesperson for the carmaker said on Tuesday.

Due to the current market situation, vehicle production will be reduced during the autumn holidays in Saxony from Oct. 2 to Oct. 13 at Volkswagen's Zwickau plant, the spokesperson said. Germany's dpa news agency first reported the news.

Production of the ID.3 model in Dresden will be suspended from Oct. 2 and resume from Oct. 16 onwards.

Volkswagen declined to comment on the number of employees affected. The carmaker said earlier this month that it would not extend the fixed-term contracts of 269 employees at its all-electric Zwickau plant.

The German carmaker is facing rising competition from Tesla and a growing array of Chinese automakers, as well as dampened demand in the European EV market due to high inflation and cuts to subsidies.

https://finance.yahoo.com/news/volkswagen-temporarily-pause-production-two-160657498.html

Appili LIKMEZ™ (ATI-1501) Metronidazole Oral Suspension OKd

 FDA approves LIKMEZ as the brand name for Metronidazole Oral Suspension (LIKMEZ is a Trademark of Saptalis Pharmaceuticals, LLC)

Currently LIKMEZ is the only liquid oral suspension of metronidazole approved in the U.S.

Patent coverage provides drug market exclusivity through at least 2039

https://www.biospace.com/article/releases/appili-therapeutics-announces-u-s-fda-approval-of-likmez-ati-1501-metronidazole-oral-suspension/

Targeted Drugs Can Vanquish a Virulent Leukemia

 For patients with acute myeloid leukemia (AML), especially those who are older or have relapsed/refractory disease, standard chemotherapy treatments often fail to change their poor clinical trajectories. These days, however, a new era of targeted therapy is improving prognoses somewhat — and raising hopes that even bigger advancements are on the horizon.

"We went almost 3 decades with nothing, then all of a sudden we've had nine approvals in 5 or 6 years," said Harvard Medical School, Boston, leukemia specialist Amir Fathi, MD, in an interview. "We've had a lot of advancement and a number of good options emerge."

However, Dr. Fathi and other hematologists cautioned that the treatment landscape is becoming more complex to navigate. And they noted that prognoses for many older patients with AML remain grim. The expensive new treatments may only extend their lifespans by a matter of months, although some are surviving for years.

As the specialists explained, there are a variety of reasons why AML is especially difficult to treat.

"AML is one of the fastest growing human cancers, with tumor cell doubling times measured in mere hours in some patients. Therefore patients can present critically ill with white blood cell counts in the hundreds of cells/mcl compared to the normal range of 4-11 cells/mcl," said leukemia specialist Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. "Because blood cells are found in every organ of the body, the sheer volume of rapidly growing cancer cells can overwhelm multiple organ systems in a very short amount of time. These rapid growing cells and the fact that the median age of diagnosis with AML is 67-70 years old makes this a clinically challenging cancer to treat. Chemotherapy strong enough to kill cancer cells run the risk of also harming the patient as well."

Also, older patients often have comorbidities, and they face risks of infection from both the disease and its treatments, said AML specialist Nicole R. Grieselhuber, MD, PhD, of the Ohio State University, Columbus, in an interview.

Enter targeted therapy, which "has allowed individuals who previously were not candidates for cytotoxic chemotherapy because of their age or possible toxicities to receive effective therapy for AML," Dr. Wang said. "Therapy directed at specific biological features of AML cells such as mutations (FLT3, IDH1, IDH2) or surface proteins (CD33) can augment the efficacy of conventional chemotherapy or in some cases (i.e., FLT3 inhibitors) be more effective than chemotherapy in controlling AML."

Targeted therapy drugs "are expected to more selectively kill cancer cells and spare normal counterparts," she added.

The FDA has approved nine targeted therapy drugs for AML in the last few years.

Retinoic acid and arsenic trioxide therapy for acute promyelocytic leukemia "has transformed this AML subtype into one of the most curable AML diseases," Dr. Wang said. A 2017 long-term analysis of the drug combination found that complete remission was reached in 96% of 54 high-risk patients and 133 low-risk patients; the 5-year survival rate was 88%. (Some patients also received gemtuzumab ozogamicin, a CD33 antibody-drug conjugate.)

According to Dr. Wang, three FLT3 inhibitors have been approved for AML with the FLT3 mutation: midostaurin and quizartinib in the frontline setting in conjunction with intensive chemotherapy and gilteritinib for relapsed/refractory FLT3-mutant AML.

A 2017 study linked midostaurin plus chemotherapy to longer survival (hazard ratio for death = 0.78; = .009), versus placebo plus chemotherapy, in patients aged 18-59. This year, a phase 3 randomized trial of quizartinib versus placebo linked the drug to longer survival median overall (31.9 months versus 15.1 months; = .032) In a 2019 trial, patients who took gilteritinib had longer median overall survival (9.3 months versus 5.6 months; HR for death = 0.64; < .001).

The success of these treatments "has led FLT3 mutant AML to be reclassified from a poor risk AML subtype to intermediate risk AML," Dr. Wang said.

2022 report about FLT3 inhibitors cautioned, however, that "several drug resistance mechanisms have been identified" and added that "the benefit of FLT3 inhibitor maintenance therapy, either post-chemotherapy or post-transplant, remains controversial, although several studies are ongoing."

Gemtuzumab ozogamicin is a monoclonal antibody connected to a chemotherapy drug, according to the American Cancer Society. "The addition of gemtuzumab ozogamicin to intensive chemotherapy has enhanced outcomes of favorable and intermediate risk disease," Dr. Wang said.

Ivosidenib, olutasidenib, and enasidenib target the IDH1 or IDH2 genes in ADL. "These drugs seem to work by helping the leukemia cells mature (differentiate) into more normal cells," according to the American Cancer Society. "Because of this, they are sometimes referred to as differentiation agents."

In older adults, a combination treatment with venetoclax, a BCL-2 inhibitor, and a hypomethylating agent has become standard, Ohio State's Dr. Grieselhuber said. The treatment is FDA approved.

There are caveats to targeted therapy in AML. The treatments can be enormously expensive, "and even patients with insurance are often shocked by the copay," Dr. Grieselhuber said. It helps to work with pharmacists, social workers, or nurse navigators to help patients afford the treatments, she said.

Side effects vary by therapy and can include QT elongation and differentiation syndrome.

Most challenging of all, many AML patients still face shortened lifespans even if new treatments are available for them.

"Typically for older patients with AML, the lifespan of patients with therapy was 5-7 months and without therapy was 2-3 months," Dr. Wang said. "Now, with regimens specifically designed for elderly and/or unfit subjects, many individuals are now routinely living more than a year: 14-18 months to 3-4 years."

But "the vast majority of AML patients will still die of their disease with overall 5-year outcomes still less than 30% in all age categories," she said. In addition, "fewer than 50% of AML patients are eligible for treatment with FDA-approved targeted therapies, as their disease biology does not express the mutation or protein needed for efficacy."

Still, she said, "this represents a vast improvement." And, she added, "in younger individuals, the combination of chemotherapy followed by allogeneic transplant has now permitted more of these individuals to be cured of their disease." Dr. Grieselhuber noted that transplants are now considered appropriate even for patients in their 60s or early 70s, and they can be combined with targeted therapy.

Dr. Grieselhuber urged colleagues to keep in mind that quality-of-life preferences will play a role in some patient choices. For example, a elderly patient may reject burdensome infusion therapy and choose a pill instead, even if it has less efficacy. "There's really no one-size-fits-all," she said.

And, she added, it can be difficult to make choices about treatment because of the lack of randomized, head-to-head data regarding new therapies.

What's on the horizon? Dr. Wang highlighted a novel class of targeted therapies called menin inhibitors for patients with NPM1-mutated AML, which she said accounts for one-third of patients with the disease. A treatment targeting disease in the 5%-10% patients with the KMT2A gene is also in the works, she said.

For now, Dr. Wang said it's essential for clinicians "to perform timely comprehensive molecular and genomic tests on all AML patients at diagnosis and relapse to determine which individuals would benefit from targeted therapy versus cytotoxic chemotherapy. And participation in clinical trials at every stage of AML therapy can help accelerate clinical development of new agents for this disease."

Dr. Fathi discloses relationships with Daiichi Sankyo, Pfizer, Rigel, Autolus, Amgen, Servier, Takeda, Orum, Menarini, Remix, AbbVie, Astellas, BMS, Ibsen, Gilead, Genentech, and AstraZeneca. Dr. Wang discloses ties with AbbVie, Astellas, BMS, CTI Biopharma, Daiichi Sankyo, Gilead, GSK, Johnson & Johnson, Kite, Kura, Novartis, Pfizer, Rigel, Sellas, and Sumitomo Pharma. Dr. Grieselhuber has no disclosures.

https://www.medscape.com/s/viewarticle/996821

First dog Commander Biden bites another Secret Service agent

 President Biden’s dog, Commander, bit another Secret Service agent at the White House on Monday, the Secret Service confirmed.

“Yesterday around 8pm, a Secret Service Uniformed Division police officer came in contact with a First Family pet and was bitten. The officer was treated by medical personnel on complex,” spokesperson Anthony Guglielmi said in a statement Tuesday.

More Than 1,800 Apply For Obesity Medicine Certification

 A record 1,889 physicians applied to take the 2023 American Board of Obesity Medicine (ABOM) certification exam, which tests doctors for their competency in treating obesity. Physician candidates will take the test between October 2-14, 2023 at Pearson VUE computer-based testing centers throughout the United States and Canada.

The 1,889 exam candidates represent more than a dozen fields of medicine including internal medicine (38%), family medicine (30%), pediatrics (6%), endocrinology (5%), surgery (4%), gastroenterology (3%) and obstetrics/gynecology (3%). They come from all 50 states, the District of Columbia, Puerto Rico, and include 57 physicians from Canada.

The exam candidates will look to join the more than 6,700 physicians who are already certified ABOM Diplomates. Since 2020, ABOM has added more than 2,500 new Diplomates.

“We hear from our Diplomates that they seek certification to demonstrate their knowledge and skill in treating obesity—an area that many have learned little about during their prior medical training,” said ABOM Board Chair Judith Korner, MD, PhD. “With recognition of obesity as a complex chronic disease and continuing advancements in effective treatment options, we believe the desire to provide the best possible care for patients with obesity will continue to attract physicians to this rapidly growing field.”

https://www.abom.org/more-than-1800-apply/

'Long COVID Blood Tests Show Distinct Immune and Hormone Function'

 Long COVID patients had specific differences in immune and hormone function than other people, blood tests showed.

Compared with matched controls, people with long COVID had marked differences in circulating myeloid and lymphocyte populations, reported Akiko Iwasaki, PhD, of Yale University in New Haven, Connecticut, and co-authors in Natureopens in a new tab or window.

Long COVID patients had exaggerated humoral responses directed against SARS-CoV-2. In addition, their antibody responses were higher against other pathogens that weren't SARS-CoV-2, especially Epstein-Barr virus (EBV).

An algorithm that incorporated blood test and self-reported survey data showed diagnostic potential with an area under the curve (AUC) of 0.94, Iwasaki and co-authors found.

"We found a number of immunological and hormonal factors that collectively are able to distinguish people with versus without long COVID at 94% accuracy," Iwasaki told MedPage Today. "This study speaks to the underlying biological causes of long COVID and provides a basis for future studies that interrogate various therapies that target the root causes of this disease."

"The reduced cortisol levels found in the long COVID patients suggest hypothalamus-pituitary-adrenal imbalance," she pointed out. "The elevated activated B cells and exhausted T cells suggest persistent antigen and potentially persistent virus infection. The EBV reactivation, which was demonstrated by others also, inform about a subset of patients who may benefit from EBV-targeting therapies."

This work is "a crucial first step towards identifying a set of biological differences between people with and without long COVID" and may lead to novel blood biomarkers for an objective diagnosis of long COVID, co-author David Putrino, PhD, of Icahn Mount Sinai in New York City, told MedPage Today.

The study "provides physicians with important insights by highlighting the fact that people with long COVID show measurable signs of hormonal and immunological dysfunction, which should serve as further irrefutable evidence that long COVID is not a functional or psychosomatic diagnosis," Putrino said.

Long COVID symptoms -- ones that lasted more than 3 months after acute infection -- affected 7.5% of U.S. adults according to 2022 CDC dataopens in a new tab or window. By June 2023opens in a new tab or window, that percentage fell to 6%.

Symptoms of long COVID can includeopens in a new tab or window postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements.

In their analysis, Iwasaki and colleagues evaluated data from about 273 people with and without long COVID from Yale and two Mount Sinai locations.

The researchers looked at several groups, including people with no previous SARS-CoV-2 infection, those who had fully recovered after COVID, and those with active long COVID symptoms for 4 months or longer after COVID. The median length of symptoms in the last group was 12 months after acute infection.

Participants completed questionnaires about symptoms, medical history, and health-related quality of life, and provided blood samples. Most acute infections in the long COVID group occurred early in 2020, when parental SARS-CoV-2 strains drove most new cases.

Long COVID participants had a mean age of 46 and convalescent controls had a mean age of 38, but the two groups did not differ in sex or hospitalization for acute COVID. The aggregated medical history of the two groups did not differ in baseline prevalence of anxiety or depression.

Fatigue (87%), brain fog (78%), memory difficulty (62%), and confusion (55%) were the most common self-reported symptoms in the long COVID group. Postural orthostatic tachycardia syndrome (POTS) also was prevalent; 38% of people with long COVID in the study had formal diagnostic testing and clinical evaluation. Half of participants with long COVID reported negative effects on employment status.

Serum cortisol was the most significant predictor of long COVID status. Other biomarkers indicated abnormal T cell activity and reactivation of multiple latent viruses, including EBV and other herpesviruses.

The findings on EBV, herpesviruses, and low cortisol are especially important, observed Ziyad Al-Aly, MD, of Washington University in St. Louis and chief of research and development at the VA St. Louis Healthcare System, who wasn't involved with the research.

"They may help inform treatment trials," he told MedPage Today. "For example, whether treating EBV or cortisol replacement would ameliorate symptoms and improve outcomes would need to be considered in the light of these findings."

People with long COVID often are told the disease is "all in your head," Al-Aly noted.

"This study provides objective evidence of significant differences in the immune profiles of people with long COVID versus matched controls." he said. "I hope this puts the 'it's all in your head' idea to rest."

Disclosures

This work was supported by the National Institute of Allergy and Infectious Diseases, FDA Office of Women's Health Research Centers of Excellence in Regulatory Science and Innovation, Emergent Ventures at the Mercatus Center, the Howard Hughes Medical Institute Collaborative COVID-19 Initiative, and the Howard Hughes Medical Institute.

Researchers reported relationships with UnitedHealth, Element Science, Identifeye, F-Prime, Refactor Health, Hugo Health, CMS, FDA, Johnson & Johnson, Google, Pfizer, Thyron, Boehringer Ingelheim, Pliant, AstraZeneca, RoBar, Veracyte, Galapagos, FibroGen, BMS, RIGImmune, Xanadu Bio, PanV, Paratus Sciences, InvisiShield Technologies, Roche, and Seranova Bio, and are inventors of a patent describing REAP technology.

Primary Source

Nature

Source Reference: opens in a new tab or windowKlein J, et al "Distinguishing features of long COVID identified through immune profiling" Nature 2023; DOI: 10.1038/s41586-023-06651-y.


https://www.medpagetoday.com/neurology/longcovid/106485