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Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

“However, we are actively looking into what we can do,” she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a covid-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to tell [patients] a variant was detected,” he said.

Complying with the lab rules “is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires,” the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

“Can our investigations be better if we can disclose that information to the patient?” she said. “I think the answer is yes.”

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― “results from sequencing will not be communicated back to the provider.”

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a covid variant is “not allowed currently” because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University’s Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government’s genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

“We’ll identify covid variants sooner and better target our efforts to stop the spread. We’re quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants,” Carole Johnson, testing coordinator for President Joe Biden’s covid-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B117 in my backyard, that’s going to make me think a little differently about how we do business.”

It’s the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won’t affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

“There wouldn’t be any difference in medical treatment whether they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in a public health emergency it’s really important for doctors to know this information.”

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of covid. “So all the issues you note on notifying patients and using [the] results will not be a problem,” he said in an email.

Companies including San Diego-based Illumina have approved covid-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn’t specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina’s chief medical officer.

He said they haven’t asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

“I think right now there’s no need for individuals to know their strains,” he said.

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As the pandemic sends thousands of recovering alcoholics into relapse, hospitals across the country have reported dramatic increases in alcohol-related admissions for critical diseases like alcoholic hepatitis and liver failure.

Alcoholism-related liver disease was a growing problem even before the pandemic, with 15 million people diagnosed with the condition around the country, and with hospitalizations doubling over the past decade.

But the pandemic has dramatically added to the toll. Although national figures are not available, admissions for alcoholic liver disease at Keck Hospital of the University of Southern California were up 30% in 2020 compared with 2019, said Dr. Brian Lee, a transplant hepatologist who treats the condition in alcoholics. Specialists at hospitals affiliated with the University of Michigan, Northwestern University, Harvard University and Mount Sinai Health System in New York City said rates of admissions for alcoholic liver disease have leapt by up to 50% since March.

High levels of alcohol ingestion lead to a constellation of liver diseases due to toxic byproducts associated with the metabolism of ethanol. In the short term, these byproducts can trigger extensive inflammation that leads to hepatitis. In the long term, they can lead to the accumulation of fatty tissue, as well as the scarring characteristic of cirrhosis — which can, in turn, cause liver cancer.

Since the metabolism of alcohol varies among individuals, these diseases can show up after only a few months of heavy drinking. Some people can drink heavily without experiencing side effects for a long time; others can suffer severe immune reactions that rapidly send them to the hospital.

Leading liver disease specialists and psychiatrists believe the isolation, unemployment and hopelessness associated with covid-19 are driving the explosion in cases.

“There’s been a tremendous influx,” said Dr. Haripriya Maddur, a hepatologist at Northwestern Medicine. Many of her patients “were doing just fine” before the pandemic, having avoided relapse for years. But subject to the stress of the pandemic, “all of a sudden, [they] were in the hospital again.”

Across these institutions, the age of patients hospitalized for alcoholic liver disease has dropped. A trend toward increased disease in people under 40 “has been alarming for years,” said Dr. Raymond Chung, a hepatologist at Harvard University and president of the American Association for the Study of Liver Disease. “But what we’re seeing now is truly dramatic.”

Maddur has also treated numerous young adults hospitalized with the jaundice and abdominal distension emblematic of the disease — a pattern she attributes to the pandemic-era intensification of economic struggles faced by the demographic. At the same time these young adults may be entering the housing market or starting a family, entry-level employment, particularly in the vast, crippled hospitality industry, is increasingly hard to come by. “They have mouths to feed and bills to pay, but no job,” she said, “so they turn to booze as the last coping mechanism remaining.”

Women may be suffering disproportionately from alcoholic liver disease during the pandemic because they metabolize alcohol at slower rates than men. Lower levels of the enzyme responsible for degrading ethanol leads to higher levels of the toxin in the blood and, in turn, more extensive organ damage in women than in men who drink the same amount. (The CDC recommends that women have one drink or less per day, compared with two or fewer for men.)

Socially, the “stress of the pandemic has, in some ways, particularly targeted women,” said Dr. Jessica Mellinger, a hepatologist at the University of Michigan. Lower wages, less job stability and the burdens of parenting tend to fall more heavily on women’s shoulders, she said.

“If you have all of these additional stressors, with all of your forms of support gone — and all you have left is the bottle — that’s what you’ll resort to,” Mellinger said. “But a woman who drinks like a man gets sicker faster.”

Nationwide, more adults are turning to the bottle during the pandemic: One study found rates of alcohol consumption in spring 2020 were up 14% compared with the same period in 2019 and drinkers consumed nearly 30% more than in pre-pandemic months. Unemployment, isolation, lack of daily structure and boredom all have increased the risk of heightened alcohol use.

“The pandemic has brought out our uneasy relationship with alcohol,” said Dr. Timothy Fong, an addiction psychiatrist at UCLA. “We’ve welcomed it into our homes as our crutch and our best friend.”

These relapses, and the hospitalizations they cause, can be life-threatening. More than 1 in 20 patients with alcohol-related liver failure die before leaving the hospital, and alcohol-related liver disease is the leading cause for transplantation.

The disease also makes people more susceptible to covid: Patients with liver disease die of covid at rates three times higher than those without it, and alcohol-associated liver disease has been found to increase the risk of death from covid by an additional 79% to 142%.

Some physicians, like Maddur, are concerned the stressors leading to increased alcohol consumption and liver disease may stretch well into the future — even after lockdowns lift. “I think we’re only on the cusp of this,” she said. “Quarantine is one thing, but the downturn of the economy, that’s not going away anytime soon.”

Others, like Lee, are more optimistic — albeit cautiously. “The vaccine is coming to a pharmacy near you, covid-19 will end, and things will begin to get back to normal,” he said. “But the real question is whether public health authorities decide to act in ways that combat [alcoholic liver disease].

“Because people are just fighting to cope day to day right now.”



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MFish • 11/10/2020 at 04:59PM • Like 1 Profile

What a petulant child. Time to grow up.

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