Search This Blog

Sunday, May 2, 2021

Real-world effectiveness of Ad26.COV2.S (J&J) adenoviral vector vaccine for COVID-19

 Juan Corchado-Garcia, 

David Puyraimond-ZemmourTravis HughesTudor Cristea-PlatonPatrick LenehanColin PawlowskiSairam BadeJohn C. O’HoroGregory J. GoresAmy W. WilliamsAndrew D. BadleyJohn HalamkaAbinash VirkMelanie D. SwiftTyler WagnerVenky Soundararajan

SARS-CoV-2 antibodies detectable 12 months after infection; antibody magnitude tied to age, COVID severity

 Eric Laing, Nusrat J Epsi, Stephanie A Richard, Emily C Samuels, Wei Wang, Russell Vassell, Daniel F Ewing, Rachel Herrup, Spencer L. Sterling, David A Lindholm, Eugene V Millar, Ryan C Maves, Derek T Larson, Rhonda E Colombo, Sharon Chi, Cristian S Madar, Tahaniyat Lalani, Anuradha Ganesan, Anthony Fries, Christopher J Colombo, Katrin Mende, Mark P Simons, Kevin L Schully, Carol D Weiss, David R Tribble, 

Brian K AganSimon D PollettChristopher C BroderTimothy H Burgess

Biden Preps Stealth Food Stamp Hike Of Up To 20% Without Congress' OK

 The Biden administration is planning to use an obscure US Department of Agriculture instrument to lay the groundwork for a long-term increase in food aid for tens of millions of Americans.

The instrument, known as the 'market basket,' is a shopping list used to determine food stamp benefits, and which can be adjusted without risking an impasse in Congress from Republican lawmakers, according to Bloomberg.

A review of the so-called Thrifty Food Plan, ordered by Biden two days after he took office, could trigger an automatic increase in benefits as soon as Oct. 1, a day after expiration of a temporary 15% boost in food stamp payments that Biden included in his $1.9 trillion Covid-relief package.

James Ziliak, director of the Center for Poverty Research at the University of Kentucky, said the re-evaluation “could result in an upward adjustment of 20% or more in the benefits.” That would amount to roughly a $136-a-month increase in the maximum benefit for a family of four, which was $680 before the temporary pandemic-related increase. -Bloomberg

"This is really meaningful," according to Harvard professor Jason Furman, who was chairman of former President Obama's Council of Economic Advisers. "It’s one of the bigger things government can do for poverty without Congress."

According to Furman, the Obama administration didn't adjust the market basket because Republicans then controlled both houses of Congress.

"We made a pragmatic decision that it not only could be overridden by a Republican Congress, but they could put something worse in its place. So we decided not to poke the bear," he said.

The decision follows a years-long campaign by anti-hunger advocates, after the basket hasn't been adjusted for six decades aside from inflation. According to the report, "The move is emblematic of a broad commitment to anti-poverty programs across the Biden administration ... In April, the Agriculture Department extended a universal free school lunch program tied to pandemic relief through the entire 2021-22 school year."

President Biden has been telegraphing the move for months - frequently reading his speechwriters' descriptions of cars lined up for miles outside food banks for boxes of groceries. Most recently Biden invoked the imagery last week during his first address to Congress.

"I didn’t ever think I’d see that in America," he said.

Advocates argue that the $22-a-day food budget USDA currently sets for a family of four is woefully inadequate and relies on outdated, unrealistic assumptions. The market basket assumes a family eats more than five pounds of beans a week, for example. And outside studies have found that the food plan requires spending about two hours a day preparing meals, largely from scratch, at a time the average American family spends just a half hour on daily food preparation.

SNAP benefits are calculated on a sliding scale based on income and the number and age of people in a household. Recipients are expected to spend 30% of their net income on food, with food stamps making up the deficit from the USDA food budget. Benefits can only be used to purchase groceries. -Bloomberg

According to a 2011 study, over 25% of SNAP recipients exhaust their monthly benefit within one week of issuance, while over half exhaust it by the second week.

We can't imagine why.

While historical reviews of the market basket - the most recent being in 2006 - aimed to keep costs constant, this time the USDA won't require it to be cost-neutral according to official Stacy Dean, who's leading the review on behalf of Agriculture Secretary Tom VIlsack.

"A core goal of the secretary is to assure nutrition security, not just food security," said Dean. "We want to make sure the benefits we are providing really and truly can support a nutritious and healthy diet."

And according to March comments from Vilsack, "It’s fair to say that the SNAP benefit is in many cases not adequate enough to provide the help and assistance that is needed," adding "I suspect that we’re going to find that the foundation of that program doesn’t meet the activities of normal American families today, and that may result in some adjustment in terms of the benefit."

https://www.zerohedge.com/personal-finance/biden-prepares-stealth-food-stamp-increase-20-without-congressional-approval

Milestone in muscular dystrophy therapy

 Muscle stem cells enable our muscle to build up and regenerate over a lifetime through exercise. But if certain muscle genes are mutated, the opposite occurs. In patients suffering from muscular dystrophy, the skeletal muscle already starts to weaken in childhood. Suddenly, these children are no longer able to run, play the piano or climb the stairs, and often they are dependent on a wheelchair by the age of 15. Currently, no therapy for this condition exists.

"Now, we are able to access these patients' gene mutations using CRISPR-Cas9 technology," explains Professor Simone Spuler, head of the Myology Lab at the Experimental and Clinical Research Center (ECRC), a joint institution of the Max Delbrück Center for Molecular Medicine in the Helmholtz Association and Charité - Universitätsmedizin Berlin. "We care for more than 2,000 patients at the Charité outpatient clinic for muscle disorders, and quickly recognized the potential of the new technology." The researchers immediately started working with some of the affected families, and have now presented their results in the journal JCI Insight. In the families studied, the parents were healthy and had no idea they possessed a mutated gene. The children all inherited a copy of the disease mutation from both parents.

Edited human muscle stem cells developed into muscle fibers in mice

The term "muscular dystrophy" is used to refer to some 50 different diseases. "They all take the same course, but differ due to the mutation of different genes," explains Spuler. "And even within the genes, different sites can be mutated." Following a genomic analysis of all patients, the researchers chose one family because of their particular form of the disease: Limb-girdle muscular dystrophy 2D/R3 is relatively common, progresses rapidly, and has a suitable docking site for the "genetic scissors" close to the mutation on the DNA.

For the study, the researchers took a sample of muscle tissue from a ten-year-old patient, isolated the stem cells, multiplied these in vitro, and used base editing to replace a base pair at the mutated site. They then injected the edited muscle stem cells into mouse muscles, which can tolerate foreign human cells. These multiplied in the rodent and most developed into muscle fibers. "With this, we were able to show for the first time that it is possible to replace diseased muscle cells with healthy ones," says Spuler. Following further tests, the repaired stem cells will be reintroduced to the patient.

Base editing - a sophisticated technique

Base editing is a newer and highly sophisticated variant of the CRISPR-Cas9 gene-editing tool. Whereas in the "classic" method, both strands of DNA are cut by these molecular scissors, the Cas enzymes used for base editing merely snip off the residual glucose from a particular base and attach a different one, thus creating a different base at the targeted site. "This tool works more like tweezers than scissors, and is perfect for carrying out targeted point mutations in a gene," says Dr. Helena Escobar, a molecular biologist in Spuler's team. "It is also a much safer method, because unwanted changes are extremely rare. In the genetically repaired muscle stem cells, we have not witnessed any misediting at unintended regions of the genome." Escobar is the study's lead author and the one who developed the technique for the muscle cells.

Autologous cell therapy - which involves removing a patient's own stem cells, editing them outside the body and then injecting them back into the muscle - will not enable sufferers who are already wheelchair-bound to walk again. "We cannot repair muscle that has already atrophied and been replaced by connective tissue," Spuler stresses. And the number of cells that can be edited in vitro is also limited. However, the study provides the first proof that a form of therapy may even be possible for a group of previously incurable diseases, and it could be used to repair small muscle defects, such as those in the finger flexor.

One step closer to a cure

But this is just the first step. "The next milestone will be to find a way to inject the base editor directly into the patient. Once inside the body, it would 'swim' around for a short while, edit all the muscle stem cells, and then quickly break down again." The team wants to start the first trials in a mouse model soon. If this also works, newborns could be tested for corresponding gene mutations in the future and the curative therapy could be initiated at a time when comparatively few cells would need to be edited.

So, what might an in vivo therapy for muscular dystrophy look like in concrete terms? This is something that scientists have been testing on animal models for some time using viral vectors. However, Helena Escobar explains that because these vectors remain in the body for too long, the risk of misediting and toxic effects is too high. "An alternative would be for mRNA molecules that contain the information for the editor to synthesize the tools in vivo," says the molecular biologist. "mRNA breaks down very quickly in the body, so the therapeutic enzymes can only remain in an active state for a short time." The therapy could probably also be repeated, if necessary. "We do not yet know whether this would need to be a therapy cycle involving several applications."

This therapeutic avenue would mean that, unlike with autologous cell therapy, not every patient would need to be treated individually. For each form of muscle therapy, one "tool" would be sufficient to cure muscle atrophy before major damage even occurred. But, for now, that is still a long way off.

###

Scientific contacts

Prof. Simone Spuler
Experimental and Clinical Research Center (ECRC)
Myology Lab
+49 30 4505-40501
simone.spuler@charite.de or simone.spuler@mdc-berlin.de

Dr. Helena Escobar
Experimental and Clinical Research Center (ECRC)
Myology Lab
+49 30 4505-540526
helena.escobar@charite.de or Helena.escobar@mdc-berlin.de

https://www.eurekalert.org/pub_releases/2021-04/mdcf-ami043021.php

Heart transplant using donation after cardiac death feasible

  A new study, presented today at the AATS 101st Annual Meeting, found that heart transplantation using donation after cardiac death (DCD) with normothermic regional perfusion (NRP) is feasible in the United States. Broader application of DCD heart transplantation has the potential to increase cardiac allograft availability by 20-30 percent. Over a one-year period, from January 2020 to January 2021, eight heart transplants were performed using cardiopulmonary bypass (CPB) for immediate regional reperfusion and cardiac unloading to accomplish optimal myocardial salvage. All hearts were successfully resuscitated and weaned from CPB with no inotropic support and all were accepted for transplantation. Post-transplant cardiac function was excellent in all recipients.

Improving the number and quality of organs available for transplantation is a key objective that improves outcomes for patients. The DCD process has been used with success in the United Kingdom, Belgium and Australia. This study is the first to measure outcomes in the United States.

"Our study addresses an important concept - the relative shortage of donors and the need for organs," explained Dr. Nader Moazami, Surgical Director of Heart Transplantation and Mechanical Circulatory Support at NYU Langone Health. "The DCD process taps into potential donors that have been used in the past for abdominal transplants but not for cardiac patients. We are excited about expanding the potential donor pool in the United States."

Preliminary data shows that DCD heart transplant with CPB allows immediate reperfusion and complete unloading of the heart, correction of metabolic derangements and real-time in-situ assessment of the heart prior to acceptance. Post-transplant cardiac function has been excellent in all cases with excellent early survival. This approach is readily adoptable for more widespread use, and will increase donor availability in the United States. During the study, six livers and 14 kidneys were recovered from the same donors, which could indicate success in increasing organ availability for non-cardiac patients as well.

Because the DCD process allows surgeons to resuscitate and assess the organ better before transplantation, the strategy should improve outcomes for patients. "This is the first study of DCD-NRP transplantation in the United States, and we already have many patients at least six months out from the transplant experiencing positive results," explained Deane Smith, MD, Assistant Professor of Cardiothoracic Surgery and Surgical Director of the Adult ECMO Program at NYU Langone Health. "Using traditional methods, there is not an effective way to assess the heart on the pump, but using DCD-NRP, we can measure cardiac output and hemodynamics before a decision is made to accept the heart, and hopefully we will improve the quality of the other organs.


"The First Clinical Heart Transplantation in The United States from Donation After Cardiac Death (DCD) using Normothermic Regional Perfusion (NRP)," Deane E Smith, Zachary N Kon, Julius A Carillo, Claudia G Gidea, Greta L Piper, Amy L Friedman, Jennifer Pavone, Alex Reyentovich, Robert Montgomery, Aubrey C Galloway, Nader Moazami , NYU Langone, New York, NY

Presented by Deane E. Smith, III, MD, May 2, 2021 at the AATS 101st Annual Meeting.

https://www.eurekalert.org/pub_releases/2021-05/aaft-sfh042821.php

How to tackle clinical trials in a pandemic

 One of the hardest lessons Feinstein Institutes for Medical Research CEO Kevin Tracey, MD, learned in 2020 was how difficult conducting successful clinical trials during a pandemic is.

"The last thing any patient wants to do is make special trips to any doctor's office or any hospital because they're in a clinical trial," he said.

The physician and his team were among the first in the U.S. to stand up trials for COVID-19 treatments. As the COVID-19 Clinical Trials Unit of New Hyde Park, N.Y.-based Northwell Health, they managed to get seven trials off the ground and enroll 1,300 patients.

"I felt like I was on a team that had been training for their whole life for a specific event, and when the time came to do their part in this event, everyone did it."

Over the course of the pandemic, Dr. Tracey realized the value a virtual trial would bring to the table. With Christina Brennan, MD, the Feinstein Institutes' vice president of research, Dr. Tracey launched Northwell Health's first at-home trial. At its center was famotidine, a heartburn drug some studies suggest could protect from serious complications and death in COVID-19 patients.

The study, which is still in progress, is designed to keep patients entirely out of the hospital during treatment. Participants, who have all been diagnosed with mild to moderate cases, receive tools including an iPad, spirometer and 240 milligrams of famotidine or placebo to be taken for 14 days. Lab and blood work is completed at home.

Dr. Tracey is looking forward to using the virtual approach in future trials; cancer trials in particular. 

"We have learned a huge amount about how to do clinical trials in an impactful way," he said. "That kind of learning will continue to improve our research enterprise at Northwell for years to come."

https://www.beckershospitalreview.com/hospital-management-administration/tackling-trials-in-a-pandemic-what-feinstein-institutes-ceo-dr-kevin-tracey-has-learned.html

Kentucky judge throws out $8B in state Medicaid contracts

 A Kentucky judge threw out $8 billion in Medicaid contracts awarded to six different insurance companies, citing multiple flaws in the state's bidding process, according to the Courier Journal

It is the state's second failed attempt at seeking bids for Medicaid contracts with outside healthcare companies. 

In a 35-page order issued April 28, Judge Phillip Shepherd cited the refusal to consider all aspects of bids and a potential conflict of interest at one of the companies as reasons. The judge also said officials refused to allow companies to make lawful oral presentations, and that they had directed state employees that won bids to dispose of their notes, according to the article.

Payers that originally scored contracts were Aetna, Humana, Wellcare Health Insurance of Kentucky, UnitedHealthcare, Molina and Anthem.

Medicaid is Kentucky's largest health plan, with 1.5 million people receiving coverage through the program. Mr. Shepherd said all current contracts will remain in place to ensure health services are not disrupted.

https://www.beckershospitalreview.com/payer-issues/kentucky-judge-throws-out-8b-in-state-medicaid-contracts.html