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Tuesday, November 9, 2021

Chinese city offers big cash rewards for clues to coronavirus outbreak

 

  • A city in China is offering nearly $16,000 to residents with information about its latest COVID-19 outbreak.
  • People should report instances of illegal hunting, animal smuggling, and border crossing to fish, and those who withhold information will be severely punished.
  • The move is part of China’s wider effort to contain the virus as it faces its worst outbreak since the start of the pandemic.

Authorities in China are offering cash rewards to residents of one city with information about the spread of the delta variant of COVID-19.

City officials in Heihe, a northeastern Chinese city that shares a border with Russia, said on Monday that 100,000 yuan, or just under $16,000, would be given in exchange for tips on the city’s latest COVID-19 outbreak, with new infections totaling 240, the Guardian reported.

“It is hoped that the general public could actively cooperate with the tracing of the virus and provide clues to the probe,” officials said in a statement, according to state media. Residents of the city should immediately report instances of illegal hunting, animal smuggling, or crossing the border into Russia to fish.

People who intentionally withhold or conceal information related to the probe will face “severe punishment” if caught, while those who have committed minor violations and have turned themselves in could be pardoned.

China’s government has recently been struggling to maintain its zero-COVID policy, which includes tight border control and lengthy quarantines for international travelers, and is currently facing its most widespread outbreak since the start of the pandemic.

South of Heihe, authorities in China’s Henan province promised this week to contain the virus’ resurgence by Nov. 15 after kindergarten children in at least five places fell ill. Party secretary Lou Yangsheng said local governments should enhance epidemiological investigations and contact tracing efforts.

Tracing measures have also been expanded in Chengdu, a city in China’s Sichuan province, where people are subject to mandatory testing and self-isolation if their mobile phones transmit through the same cell tower as someone with COVID-19 over a two-week period.

Meanwhile, health officials are calling for increased vaccinations, particularly for children, and booster shots.

“We have seen increased infections in children, with the rates of severe illness and mortality surpassing influenza in some countries…and the hospitalization rate for children is now more than 10 times higher than earlier this year,” Wang Qinghua, chief immunologist of the Chinese Centers for Disease Control and Prevention, said at a press conference over the weekend, according to state media.

https://thehill.com/changing-america/well-being/prevention-cures/580776-chinese-city-offers-big-cash-rewards-for-clues

Pfizer, BioNTech again seek U.S. nod for COVID-19 vaccine boosters in all adults

 Pfizer Inc and BioNTech once again requested the U.S. Food and Drug Administration on Tuesday to authorize booster doses of their COVID-19 vaccine for all adults.

The FDA in September had authorized Pfizer's boosters for people aged 65 and above, and other individuals at high risk of being infected because of their jobs, after a panel of expert advisers to the agency rejected Pfizer's request for authorization of the booster in all individuals aged 16 and above.

The panelists suggested the evidence supporting broad approval was inadequate, and they wanted to see more safety data, especially concerning the risk of heart inflammation in younger people after vaccination.

Moderna's booster doses have since been cleared for use in similar group of patients, and a booster shot of Johnson & Johnson's COVID-19 vaccine has been authorized for use as well. Roughly 25 million Americans had received a booster, as of Monday.

Pfizer and U.S. health officials have argued that the boosters prevent hospitalizations and deaths and that emerging data indicates they can slow mild infections as well.

U.S. President Joe Biden's administration in August announced plans to roll out booster doses for all adults in September, before the FDA's advisers had recommended a limited authorization.

https://finance.yahoo.com/news/pfizer-biontech-again-seek-u-195225963.html

Biogen's Aduhelm records one patient death. Is the controversial Alzheimer’s drug to blame?

 Doctors already have reservations about Biogen’s controversial Alzheimer’s disease drug, Aduhelm. Now a reported death will likely trigger more doubts around its use.

One patient death after treatment with Aduhelm was reported to the FDA Adverse Event Reporting System (FAERS), according to the agency’s latest update rounding up cases it had received through the end of September. The fatal case came from a 75-year-old female in Canada after she was diagnosed with brain swelling and bleeding, or amyloid-related imaging abnormality (ARIA).

All the recently published side effect cases related to Aduhelm are “under careful review as well as medical evaluation,” including the death, Biogen said in an emailed response to a request for comment. “We continue to work with the reporting physician as well as global regulators to further understand the case.”

ARIA is a known side effect of Aduhelm as well as other similar antibody drugs that target the toxic amyloid plaque build-up in the brain. On Aduhelm’s label, the FDA specifically recommends MRI monitoring of ARIA events before starting the treatment and the 7th and 12th infusions. The risk of ARIA paired with fuzzy clinical trial efficacy data are among the key reasons critics objected to the FDA’s accelerated approval of Aduhelm.

At the FDA-recommended dosing, Aduhelm could lead to ARIA cases, Biogen learned from its clinical trials. But most cases didn’t show any symptoms, and they were largely mild to moderate and transient and could be managed by lowering the dosing strength, according to the company. Notably, no death was reported from the clinical programs. However, researchers have voiced concerns over the lack of longer-term data on ARIA related to Aduhelm treatment.

In addition to the fatal case, the FAERS program also recorded three other new ARIA cases between July and September. All cases were serious and required hospitalization. As they all came from outside the U.S., RBC Capital Markets analyst Brian Abrahams wrote in a Monday note that the cases probably emerged from an open-label phase 3b safety study of Aduhelm dubbed Embark. 

Biogen has found an increased ARIA incidence rate for Aduhelm in carriers of the APOE-4 gene. But the drug’s prescribing information doesn’t require APOE screening.

Despite Aduhelm’s known ARIA risk, it’s still early to draw a causal relationship between the latest death and the Biogen drug, Abrahams noted. That said, he pointed out the patient wasn’t very old and didn’t appear to have any other contributing conditions listed, such as constipation, high cholesterol and insomnia.

If the case were indeed caused by Aduhlem, “[t]his would potentially highlight that ARIA is a real adverse event that can lead to negative outcomes, something that may maintain physician cautiousness on adu use at least initially and limit the medium-term” market opportunity, Abrahams said. 

The ARIA problem “illustrates why physicians may be more conservative about initial prescribing even once there is greater access until experience with benefit-risk accrues,” Abrahams said.

Thanks to wide physician pushback, Aduhelm only brought in $300,000 in third-quarter sales, way below industry watchers’ already depressed expectations.

https://www.fiercepharma.com/pharma/biogen-s-aduhelm-records-one-patient-death-controversial-alzheimer-s-drug-to-blame

Some Babies Get Bad Start on Obesity Risk From Mom

 Babies of mothers who have unhealthy obesity (that is, obesity along with other metabolic comorbidities) appear to have greater levels of adiposity when compared with the offspring of women with metabolically healthy obesity, researchers reported.

At the time of birth, children of mothers with unhealthy obesity weighed an average of 0.62 kg (1.4 lb) more compared with children born to mothers with so-called health obesity (P=0.001), said Emily Flanagan, PhD, a postgraduate researcher at Pennington Biomedical Research Center in Baton Rouge, Louisiana, in a presentation at the ObesityWeek virtual meeting. The findings were also published simultaneously in Obesity.

Flanagan also reported that the children of mothers with unhealthy obesity had 0.27 kg (0.6 lb) more fat mass (P=0.001) and a percentage of fat 5.8% greater (P=0.02) than children of women with healthy obesity.

For the study, she and her colleagues focused on the metabolic conditions in early pregnancy. The team defined the phenotype of mothers with unhealthy obesity according to the National Cholesterol Education Program Adult Treatment Panel III guidelines for metabolic risk.

Unhealthy metabolic risk factors included the following:

  • Systolic blood pressure >130 mm Hg or diastolic blood pressure >85 mm Hg
  • HDL cholesterol <50 mg/dL
  • LDL cholesterol ≥100 mg/dL
  • Triglycerides ≥150 mg/dL
  • Glucose ≥100 mg/dL

Mothers with two or more of these conditions were considered to have unhealthy obesity. The researchers compared the data for seven women who fit the criteria for unhealthy obesity with those of seven other women with healthy obesity who had none of the risk factors. Flanagan noted that there were also 29 women who had one metabolic risk factor, but these women were excluded from the analysis to avoid ambiguous results.

Women with unhealthy obesity had higher levels of glucose and triglycerides (P<0.001), as well as lower activity energy expenditure, the group found.

Gestational age at delivery and infant age at assessment were similar between the infants born to mothers with unhealthy obesity and those with healthy obesity. Maternal body mass index (BMI), gestational weight gain, and fat accretion also were similar between the two groups of mothers.

The women with healthy obesity gave birth to five boys and two girls; the women with unhealthy obesity gave birth to three boys and four girls, but Flanagan said that the sex of the babies was not a significant factor in the study.

"We are the first, to our knowledge, to show that maternal obesity coupled with risk factors for cardiometabolic disease likely results in prolonged fetal exposure to excess growth-promoting substrates," the researchers wrote. "Future studies should examine the influence of the preexisting maternal metabolic milieu on adverse maternal and infant outcomes on a large scale."

The study identifies a population of women with obesity who are "highly vulnerable to adverse offspring outcomes and highlights the importance for prenatal or preconception interventions that alter the metabolic milieu in this population, who are most at need," the investigators continued. "It is possible that different obesity phenotypes may also need to be considered when evaluating prenatal intervention effects on offspring outcomes. Evaluating metabolic health in conjunction with BMI screening at the start of pregnancy may be clinically relevant to understanding the intergenerational transmission of obesity."

Asked for her perspective, Sharon Zarabi, RD, CDN, a registered dietitian nutritionist at Lenox Hill Hospital in New York City, told MedPage Today: "As obesity rates continue to grow, it will be affecting the outcomes of maternal child health. Nutrients are passed to the fetus through the placenta, so it's important that mommy be vigilant with lifestyle, stress management, and of course food choices."

Weight gain is normal, but the question is how much, how fast, and how much inflammation might be causing metabolic syndrome (i.e., preeclampsia, gestational diabetes, triglyceridemia, etc.), said Zarabi, who was not involved with the study.

"Precision medicine is starting to gain traction, personalizing medicine based on medical evaluation and the body's metabolic system," Zarabi continued. "This includes body fat percentage, lipid panels, glucose curves, insulin levels, which give us a deeper dive than just looking at body mass index and classifying a patient with obesity or overweight."

She said it is important to look further at specific conditions as they impact quality of health. If the mother is consuming an energy-dense diet loaded with the "typical western diet of salt, sugar, and fat -- completely devoid of vitamins and minerals -- how would you expect the fetus to develop? We are a product of what we eat, or in prenatal terms, what we are fed."

She said that obstetricians and gynecologists should be more vigilant with their conversations about health and lifestyle medicine, and encourage "walks, physical activity, and clean eating. The stress of pregnancy can lead to missing out on the most important treatment -- food and movement for optimal outcomes to health for both mommy and baby."

Regarding possible study limitations, Flanagan and co-authors acknowledged the small sample size, which likely limits the observed power. However, they said, the study is strengthened by the "conservative delineation of metabolic phenotypes in women with obesity during early pregnancy and the rigorous measurement of potential confounding variables, including maternal energy intake and expenditure. Our gold standard measures allow us to exclude influence of these variables on infant body composition."


Disclosures

Flanagan and co-authors reported no conflicts of interest.

Zarabi disclosed no relevant relationships with industry in relation to her comments.

Is 'Long COVID' All in Your Head?

 Self-reported COVID-19 was more likely to be associated with a variety of prolonged physical symptoms, while laboratory-confirmed infection was more likely to be associated only with persistent anosmia, French researchers found.

Those who self-reported having COVID-19 were more likely to report symptoms such as persistent anosmia, breathing difficulties, chest pain, palpitations, and fatigue, while those who actually had positive serology for SARS-CoV-2 were only more likely to report persistent anosmia (OR 2.72, 95% CI 1.66-4.46), noted Cédric Lemogne, MD, PhD, of Hôpital Hôtel-Dieu in Paris, and colleagues in JAMA Internal Medicine.

There is a lack of data on who suffers from "long COVID," they added. Persistent symptoms "may not emanate from SARS-CoV-2 infection per se but instead may be ascribed to SARS-CoV-2 despite having other causes."

Lemogne's group examined data from the population-based Constances cohort. Participants ages 18 to 69 self-sampled dried blood spots from a provided kit from May to November 2020, which underwent serology testing for COVID-19. From December 2020 to January 2021, they completed a questionnaire, which included the questions, "Since March 2020, do you think you have been infected with COVID-19?" and "Since March 2020, have you had any of the following symptoms that you did not usually have before?"

Overall, 35,852 people were invited to participate, and 26,823 had completed data and were included in the survey. Mean age of participants was 49, and 51% were women. Compared with the whole Constances cohort, participants tended to be older and men, with more education, a higher income, and better self-reported health. There were 1,091 people with a positive serology test for SARS-CoV-2.

After adjustment, positive belief was significantly associated with higher odds of having all persistent symptoms, including:

  • Anosmia (OR 16.37, 95% CI 10.21-26.24)
  • Breathing difficulties (OR 7.75, 95% CI 5.25-11.43)
  • Chest pain (OR 6.58, 95% CI 4.02-10.75)
  • Palpitations (OR 5.14, 95% CI 3.18-8.29)
  • Fatigue (OR 4.90, 95% CI 3.79-6.33)

However, reports of hearing impairment and sleep problems among this group were non-significant.

Interestingly, Lemogne and colleagues then limited their analysis to only those with a positive belief who attributed their persistent symptoms to COVID-19, and found that a positive test result was associated only with anosmia (OR 2.97, 95% CI 1.58-5.57).

"Most previous studies assessing 'long COVID' included only patients who had COVID-19 infection, thus lacking a control group of patients who did not have the infection," they wrote.

They also pointed out that among those who reported they had the disease, half had a negative serology test result.

"From a clinical perspective, patients in this situation should be offered a medical evaluation to prevent their symptoms being erroneously attributed to COVID-19 infection and to identify cognitive and behavioral mechanisms that may be targeted to relieve the symptoms," the authors added.

Limitations to the data included selection biases, a non-comprehensive list of long COVID symptoms, and the fact that the authors analyzed persistent symptoms separately versus "clustering symptoms," which may lead to different outcomes.


Disclosures

The Constances cohort is funded by the French National Research Agency, Caisse Nationale d'Assurance Maladie, the French Ministry of Health, the Ministry of Research, and the Institut National de la Santé et de la Recherche Médicale, as well as AstraZeneca, Lundbeck, L'Oréal, and Merck Sharp & Dohme Corp.

Lemogne disclosed support from Boehringer Ingelheim, Janssen-Cilag, Lundbeck, and Otsuka Pharmaceutical.

Other co-authors disclosed support from Gilead, ViiV Healthcare, Merck Sharp & Dohme Corp, Sanofi, the French Ministry of Research, the French Institute of Health and Medical Research, and Lundbeck.

Assessments in Alzheimer's patients treated with plasma exchange

 Mercè Boada,Oscar L. López,Javier Olazarán,Laura Núñez,Michael Pfeffer,Orlando Puente,Gerard Piñol-Ripoll,José E. Gámez,Fernando Anaya,Dobri Kiprov,Montserrat Alegret

DOI:  https://doi.org/10.1002/alz.12477

PDF: https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/alz.12477

Abstract

Introduction

We report the effects of plasma exchange (PE) with albumin replacement on neuropsychological, neuropsychiatric, and quality-of-life (QoL) outcomes in mild-to-moderate Alzheimer's disease (AD) patients in a phase 2b/3 trial (Alzheimer's Management by Albumin Replacement [AMBAR] study).

Methods

Three hundred forty-seven patients were randomized into placebo (sham-PE) and three PE-treatment arms with low/high doses of albumin, with/without intravenous immunoglobulin (IVIG). Specific test measurements were performed at baseline; month 2 (weekly conventional PE); months 6, 9, and 12 (monthly low-volume PE [LVPE]); and month 14.

Results

The PE-treated mild-AD cohort improved their language fluency and processing speed versus placebo at month 14 (effect sizes: >100%; P-values: .03 to .001). The moderate-AD cohort significantly improved short-term verbal memory (effect sizes: 94% to >100%; P-values: .02 to .003). The progression of the neuropsychiatric symptoms of PE-treated was similar to placebo. Mild-AD patients showed improved QoL (P-values: .04 to .008).

Discussion

PE-treated AD patients showed improvement in memory, language abilities, processing speed, and QoL-AD. No worsening of their psychoaffective status was observed.

https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12477

Hundreds of Doctors Urge Facebook to Disclose 'Disinfo' Data

 More than 500 physicians and public health professionals in the U.S. have signed a letter demanding that Facebook divulge its data around COVID-19 disinformation.

The letter, which was initially shared exclusively with USA Today and then posted on the Doctors for America website, called the lack of transparency "deadly."

"The recent Facebook whistleblower disclosures have confirmed what many of us have suspected for a long time: that Facebook has repeatedly stonewalled the public, lawmakers and academics over the last 18 months despite having had 'deep knowledge' about the scope and nature of COVID-19 and vaccine disinformation across its apps," the letter stated.

"So many deaths could have been prevented, and we must act with haste to prevent more, particularly with vaccines becoming imminently available for young children," it continued. "We simply cannot afford another deadly round of COVID and vaccine misinformation."

The top three signatures were from Céline Gounder, MD, of NYU Grossman School of Medicine in New York City; Kavita Patel, MD, of the Brookings Institution in Washington, D.C.; and Craig Spencer, MD, MPH, of Columbia University Medical Center in New York City.

Doctors for America said it "mobilizes doctors and medical students to be leaders in putting patients over politics on the pressing issues of the day to improve the health of our patients, communities, and nation."

In a Twitter post about the letter, Gounder noted that healthcare professionals and public health officials "have been fighting multiple battles & multiple fronts over the course of the pandemic. Social media is yet another battleground."

She asked why Facebook has yet to de-platform members of the "Disinformation Dozen," referring to the report by the Center for Countering Digital Hate, which found that 12 anti-vaxxers are responsible for some two-thirds of anti-vaccine content on social media.

Some physicians made that list, including Joseph Mercola, DO; Sherri Tenpenny, DO; and Christiane Northrup, MD.

"These people are still out there, spreading dangerous disinformation," Gounder tweeted.

The letter noted that on July 15, U.S. Surgeon General Vivek Murthy, MD, issued a federal advisory about the public health threat posed by misinformation.

Facebook must take "immediate, urgent action to stop the deadly spread of COVID-19 disinformation on its platforms," the letter stressed. "Facebook must disclose all data about the scope, reach, and content of this disinformation and its impact on users for evaluation by independent public health researchers."

The letter stated that data already released by Facebook have "fallen far short of what the public deserves to know."

"For Facebook to achieve actual transparency, it must go beyond providing select data points to the public and provide meaningful data from its vast data trove to the public health community," the letter continued. "This will assist experts in understanding both how disinformation has rampantly spread on the platform and how to overcome the skepticism about vaccines that has arisen from it."

In an emailed statement to USA Today, a spokesperson for Meta (the new parent organization for Facebook) said that the company is working to distribute "reliable information" about COVID-19, and noted that vaccine hesitancy among Facebook users in the U.S. has fallen by 50% since January.

"Tracking and sharing data on the prevalence of misinformation is difficult for any subject, but especially for COVID-19 where the facts and guidance about the pandemic are updated over time. This is why no major tech company releases this data," the spokesperson told USA Today. "Despite all of these complications, we've removed more than 20 million pieces of content that violate our COVID misinformation policies, permanently banned thousands of repeat offenders from our services, and connected more than 2 billion people to reliable information about COVID-19 and vaccines."

"We will continue our dedication to ensuring billions of people are getting reliable information about COVID-19 on our services," the Meta spokesperson said.

https://www.medpagetoday.com/special-reports/exclusives/95541