#but I do find it very worrisome that we have no officially confirmed cases

[culmaer]

¶

[rwbyinserts]

Marrow and Qrow with a crush headcanons

Marrow

Marrow is a mix between soft and a total showoff when he realizes he likes you - he wants to impress you in whatever way he can, and he’s not going to hesitate to try.

Of course, that’s after the internal struggle and denial that he has to go through when it starts to hit him. It seems like everyone else around him comes to the conclusion before he even does. It’s obvious in how he acts when you’re around - his bravado comes out more, he puffs out his chest as if he has something to prove, etc. Of course all of it is a huge contrast to how his tail wags whenever he notices you.

It would probably be Clover who points it out to him first, to which he denies it. Then Elm and Vine. It takes Harriet straight up calling him out on it though for him to give in just a bit and realize they’re probably onto something. That’s when the internalized panic actually starts. When he’s with everyone else, he’s a showoff if you’re watching. When he’s alone though...

How should he go about this? How might this affect his job? How might this affect his friendship with you? He tries not to let it get the best of him, especially while you’re around, as the very last thing he wants is to let you notice his stress.

Of course, it’s not hard to notice. Regardless of how cool he tries to act he often wears his emotions on his sleeve, and you begin to notice how his tail goes from wagging to drooping a bit when he zones out while you talk. It’s worrisome, to say the least, and though you’d try not to let it get to you it gets hard at times.

It’s when you’re alone together and he realizes something is wrong that he gets concerned and pushes past his own worries, trying to figure out what’s wrong with you. His heart breaks a bit when you answer.

“I just want to know what happened. You were always so… happy? When we talked before. Now you’re not.”

Now more than ever before he wishes his emotions weren’t so easy to read, but he knows not to dwell on that. Now isn’t the time for that. He’s aware of the risks for sure, but it was now or never.

“I just… I realized something.” He starts, and he notices how your attention perks up a bit. He hates how nervous his words made you look, as if you expected bad news. He hoped this wouldn’t be bad news. “Everyone else realized too. I mean, my team. I like you. A lot? I just don’t want to screw this up.” It was almost cute how he worded it, though he certainly didn’t realize that.

Relief only came to him when he saw your worried expression shift into one of surprise and then a sincere happiness that he hadn’t expected, for whatever reason. Apparently just because his emotions were easy to read, he sure wasn’t the best at reading yours when it involved him. When you confirm you feel the same way, his tail finally starts to wag again, and he returns your smile with a softer grin.

From then on, expect him to go a bit overboard in showing off just how cool he really is. He has to make up for lost time after all.

Qrow

Qrow isn’t quite as smooth as he may lead others to think, especially not when it comes to genuine emotion.

This man has been a loner for quite a while. Sure, a lot of it has to do with his semblance and the immense paranoia that must come with it when it comes to getting close to others, but it adds up over time. It’s become difficult for him to process just how to act and what he should do about it.

That’s not to say he’s unbearable to be around once he develops feelings - it’s more an internal struggle with him that he’s very good at playing off. In fact, it may be almost difficult to notice any difference in him. He’ll still probably flirt with you at times, but it comes off as his typical playful, almost teasing way of doing so.

At most, you might notice him slipping away a bit more to drink or being alone with his own thoughts. He doesn’t often drink around you, and when he does it’s not his usual self-destructive amount. Of course if you ever bring this up to him, he’ll wave it off with a bit of a chuckle and a joke.

He can’t deny to himself that you’re right though. Whether it’s because he wants to be more sober in case something does happen to you while you’re in his presence or because he simply doesn’t feel the need to drink as much to distract himself while you’re around, even he’s not completely sure. Probably a mixture of the two though.

You’d notice him occasionally following you in his crow form, too, as by then you no doubt know about it. It’d be almost charming, in a way, and keep you feeling safe. 

On that note it’s almost funny how conflicting he’s being towards himself - on one hand the idea of getting too close terrifies him, lest something happen to you because of it. On the other, being too far away from you makes him worry he won’t be there to protect you if you need him. To say he’s torn is an understatement, but he at least handles it well.

Eventually though if you were to bring up how he acts around you, he wouldn’t deny that too much. At most he might just purse his lips in thought, and it’s clear then that something is very much on his mind. It wouldn’t be too concerning just because that’s how he’s always been - the overthinking brooder of the group. Even so you’d find it in you to ask him if something was the matter.

Despite his concerns, he would tell you straight up. “Y’know what? I think your charm is doing me in. There’s a reason I’m always around even knowing you can handle yourself.”

At first, you think he’s kidding. You think it’s just his usual playful flirting with nothing to really back it up. When you see that look in his eyes though, looking so much more genuine than you’re used to… not to mention the fact he’s as sober as you, it starts to hit you that maybe he isn’t joking.

He chuckles when he sees your expression though, his attention shifting elsewhere. It’s obvious at that moment he doesn’t think that you return the sentiment, and he’s trying to take it in stride.

“I’ve… been hoping, actually. I mean, why else would I not tell you to stop following?” Your voice brought him back to the situation at hand, giving him pause. You had a point. You had always been adamant about fending for yourself in a lot of situations, and he had even thought it was unusual you hadn’t told him to buzz off. 

After that day… you may just have to tell him to let you be once in a while though. If you thought he was protective and careful before, you haven’t anything once you were an official couple.

[foreverlogical]

Donald Trump’s descent into madness continues.

The latest manifestation of this is a report in The New York Times that the president is weighing appointing the conspiracy theorist Sidney Powell, who for a time worked on his legal team, to be special counsel to investigate imaginary claims of voter fraud.

As if that were not enough, we also learned that former National Security Adviser Michael Flynn, who was pardoned by the president after pleading guilty to lying to the FBI, attended the Friday meeting. Earlier in the week, Flynn, a retired lieutenant general, floated the idea (which he had promoted before) that the president impose martial law and deploy the military to “rerun” the election in several closely contested states that voted against Trump. It appears that Flynn wants to turn them into literal battleground states.\

None of this should come as a surprise. Some of us said, even before he became president, that Donald Trump’s Rosetta Stone, the key to deciphering him, was his psychology—his disordered personality, his emotional and mental instability, and his sociopathic tendencies. It was the main reason, though hardly the only reason, I refused to vote for him in 2016 or in 2020, despite having worked in the three previous Republican administrations. Nothing that Trump has done over the past four years has caused me to rethink my assessment, and a great deal has happened to confirm it.

Given Trump’s psychological profile, it was inevitable that when he felt the walls of reality close in on him—in 2020, it was the pandemic, the cratering economy, and his election defeat—he would detach himself even further from reality. It was predictable that the president would assert even more bizarre conspiracy theories. That he would become more enraged and embittered, more desperate and despondent, more consumed by his grievances. That he would go against past supplicants, like Attorney General Bill Barr and Georgia Governor Brian Kemp, and become more aggressive toward his perceived enemies. That his wits would begin to turn, in the words of King Lear. That he would begin to lose his mind.

So he has. And, as a result, President Trump has become even more destabilizing and dangerous.

“I’ve been covering Donald Trump for a while,” Jonathan Swan of Axios tweeted. “I can’t recall hearing more intense concern from senior officials who are actually Trump people. The Sidney Powell/Michael Flynn ideas are finding an enthusiastic audience at the top.”

Even amid the chaos, it’s worth taking a step back to think about where we are: An American president, unwilling to concede his defeat by 7 million popular votes and 74 Electoral College votes, is still trying to steal the election. It has become his obsession.

In the process, Trump has in too many cases turned his party into an instrument of illiberalism and nihilism. Here are just a couple of data points to underscore that claim: 18 attorneys generals and more than half the Republicans in the House supported a seditious abuse of the judicial process.

And it’s not only, or even mainly, elected officials. The Republican Party’s base has often followed Trump into the twilight zone, with a sizable majority of them affirming that Joe Biden won the election based on fraud and many of them turning against medical science in the face of a surging pandemic.

COVID-19 is now killing Americans at the rate of about one per minute, but the president is “just done with COVID,” a source identified as one of Trump’s closest advisers told The Washington Post. “I think he put it on a timetable and he’s done with COVID ... It just exceeded the amount of time he gave it.”

This is where Trump’s crippling psychological condition—his complete inability to face unpleasant facts, his toxic narcissism, and his utter lack of empathy—became lethal. Trump’s negligence turned what would have been a difficult winter into a dark one. If any of his predecessors—Barack Obama, George W. Bush, Bill Clinton, George H. W. Bush, and Ronald Reagan, to go back just 40 years—had been president during this pandemic, tens of thousands of American lives would almost surely have been saved.

“My concern was, in the worst part of the battle, the general was missing in action,” said Maryland Governor Larry Hogan, one of the very few Republicans to speak truth in the Trump era.

In 30 days, Donald Trump will leave the presidency, with his efforts to mount a coup having failed. The encouraging news is that it never really had a chance of succeeding. Our institutions, especially the courts, will have passed a stress test, not the most difficult ever but difficult enough, and unlike any in our history. Some local officials exhibited profiles in courage, doing the right thing in the face of threats and pressure from their party. And a preponderance of the American public, having lived through the past four years, deserve credit for canceling this presidential freak show rather than renewing it. The “exhausted majority” wasn’t too exhausted to get out and vote, even in a pandemic.

But the Trump presidency will leave gaping wounds nearly everywhere, and ruination in some places. Truth as a concept has been battered from the highest office in the land on an almost hourly basis. The Republican Party has been radicalized, with countless Republican lawmakers and other prominent figures within the party having revealed themselves to be moral cowards, even, and in some ways especially, after Trump was defeated. During the Trump presidency, they were so afraid of getting crosswise with him and his supporters that they failed the Solzhenitsyn test: “The simple act of an ordinary brave man is not to participate in lies, not to support false actions! His rule: Let that come into the world, let it even reign supreme—only not through me.

”During the past four years, the right-wing ecosystem became more and more rabid. Many prominent evangelical supporters of the president are either obsequious, like Franklin Graham, or delusional, like Eric Metaxas, and they now peddle their delusions as being written by God. QAnon and the Proud Boys, Newsmax and One America News, Alex Jones and Tucker Carlson—all have been emboldened.

These worrisome trends began before Trump ran for office, and they won’t disappear after he leaves the presidency. Those who hope for a quick snapback will be disappointed. Still, having Trump out of office has to help. He’s going to find out that there’s no comparable bully pulpit. And the media, if they are wise, will cut off his oxygen, which is attention. They had no choice but to cover Trump’s provocations when he was president; when he’s an ex-president, that will change.

For the foreseeable future, journalists will rightly focus on the pandemic. But once that is contained and defeated, it will be time to go back to focusing more attention on things like the Paris Accords and the carbon tax; the earned-income tax credit and infrastructure; entitlement reform and monetary policy; charter schools and campus speech codes; legal immigration, asylum, assimilation, and social mobility. There is also an opportunity, with Trump a former president, for the Republican Party to once again become the home of sane conservatism. Whether that happens or not is an open question. But it’s something many of us are willing to work for, and that even progressives should hope for.Beyond that, and more fundamental than that, we have to remind ourselves that we are not powerless to shape the future; that much of what has been broken can be repaired; that though we are many, we can be one; and that fatalism and cynicism are unwarranted and corrosive.

There’s a lovely line in William Wordsworth’s poem “The Prelude”: “What we have loved, Others will love, and we will teach them how.

”There are still things worthy of our love. Honor, decency, courage, beauty, and truth. Tenderness, human empathy, and a sense of duty. A good society. And a commitment to human dignity. We need to teach others—in our individual relationships, in our classrooms and communities, in our book clubs and Bible studies, and in innumerable other settings—why those things are worthy of their attention, their loyalty, their love. One person doing it won’t make much of a difference; a lot of people doing it will create a culture.

Maybe we understand better than we did five years ago why these things are essential to our lives, and why when we neglect them or elect leaders who ridicule and subvert them, life becomes nasty, brutish, and generally unpleasant.

Just after noon on January 20, a new and necessary chapter will begin in the American story. Joe Biden will certainly play a role in shaping how that story turns out—but so will you and I. Ours is a good and estimable republic, if we can keep it.

PETER WEHNER is a contributing writer at The Atlantic and a senior fellow at the Ethics and Public Policy Center. He writes widely on political, cultural, religious, and national-security issues, and he is the author of The Death of Politics: How to Heal Our Frayed Republic After Trump.

[grootpoepjeplasjehoofd]

Problems with a government-created coronavirus test have limited the United States’ capacity to rapidly increase testing, just as the outbreak has entered a worrisome new phase in countries worldwide. Experts are increasingly concerned that the small number of U.S. cases may be a reflection of limited testing, not of the virus’s spread.

While South Korea has run more than 35,000 coronavirus tests, the United States has tested only 426 people, not including people who returned on evacuation flights. Only about a dozen state and local laboratories can now run tests outside of the Centers for Disease Control and Prevention in Atlanta because the CDC kits sent out nationwide earlier this month included a faulty component.

U.S. guidelines recommend testing for a very narrow group of people — those who display respiratory symptoms and have recently traveled to China or had close contact with an infected person.

But many public health experts think that in light of evidence that the disease has taken root and spread in Iran, Italy, Singapore and South Korea, it’s time to broaden testing in the United States. Infectious disease experts fear that aside from the 14 cases picked up by public health surveillance, there may be other cases, undetected, mixed in with those of colds and flu. What scares experts the most is that the virus is beginning to spread in countries outside China, but no one knows whether that’s the case in the United States, because they aren’t checking.

“Coronavirus testing kits have not been widely distributed to our hospitals and public health labs. Those without these kits must send samples all the way to Atlanta, rather than testing them on site, wasting precious time as the virus spreads,” said Senate Minority Leader Charles E. Schumer (D-N.Y.).

In a congressional hearing Tuesday, Sen. Patty Murray (D-Wash.) pressed Health and Human Services Secretary Alex Azar on whether the CDC test was faulty. He denied that the test did not work.

But in a news briefing that was going on about the same time, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said that she was “frustrated” about problems with the test kits and that the CDC hoped to send out a new version to state and local health departments soon.

“I think we are close,” she said. She said that the agency is working as fast as possible on the tests, but that the priority is making sure they are accurate.

Currently, she said, a dozen state and local health departments can do the testing, although positive results need to be confirmed by the CDC. She also said she hoped that tests from commercial labs would soon come online.

Messonnier said the agency was weighing widening its testing protocols to include people traveling to the United States from countries beyond mainland China, considering the rapid spread of the virus in other places in recent days.

The nation’s public health laboratories, exasperated by the malfunctioning tests in the face of a global public health emergency, have taken the unusual step of appealing to the Food and Drug Administration for permission to develop and use their own tests. In Hawaii, authorities are so alarmed about the lack of testing ability that they requested permission from the CDC to use tests from Japan. A medical director at a hospital laboratory in Boston is developing an in-house test, but is frustrated that his laboratory won’t be able to use it without going through an onerous and time-consuming review process, even if demand surges.

“This is an extraordinary request, but this is an extraordinary time,” said Scott Becker, the chief executive of the Association of Public Health Laboratories, which is asking the FDA for permission to allow the laboratories to create and implement their own laboratory-developed tests.

At one hospital in the Mid-Atlantic region, a patient who recently returned from Singapore, which has 90 cases, was admitted to the hospital with mild upper respiratory symptoms, according to a hospital official who spoke on the condition of anonymity to protect the patient’s privacy. The patient tested negative for flu. Because of underlying medical conditions, the person was at higher risk for severe illness if this was a coronavirus infection.

Even though clinicians suspected coronavirus, and treated the person for it and placed the patient in isolation, the patient was not tested.

“If this person had returned from mainland China, they would have been tested for coronavirus,” the official said. The patient recovered and was discharged to their home.

Testing also affects other aspects of care.

People with confirmed cases can enroll in clinical trials for therapeutics. For patients who need more intense care in a facility with a biocontainment unit, that facility can receive reimbursement from the federal government for care, the official said.

The CDC announced a week and a half ago that it would add pilot coronavirus testing to its flu surveillance network in five cities, a step toward expanded testing of people with respiratory symptoms who didn’t have other obvious risk factors. Specimens that test negative for flu will be tested for coronavirus. But that expanded testing has been delayed because of an unspecified problem with one of the compounds used in the CDC test. About half of state labs got inconclusive results when using the compound, so the CDC said it would make a new version and redistribute it.

To public health experts, the delays — and lack of transparency about what, exactly, is wrong with the test — are extremely concerning.

“We have over 700 flights every month between Hawaii and Japan or South Korea,” where the virus is spreading in the community, said Hawaii Lt. Gov. Josh Green, who is also an emergency physician. It’s unlikely that the CDC would allow state labs to accept a test from another nation, he said, but “this is an exceptional circumstance.”

In a letter to the FDA, the Association of Public Health Laboratories, which represents state and local laboratories, asked the agency to use “enforcement discretion” to allow the laboratories to create and use their own laboratory-developed tests.

“While we appreciate the many efforts underway at CDC to provide a diagnostic assay to our member labs … this has proven challenging and we find ourselves in a situation that requires a quicker local response,” said the letter, which was co-signed by Becker. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories.”

Because a public health emergency has been declared, certified hospital laboratories that usually have the ability to internally develop and validate their own tests can’t use them without applying for an “emergency use authorization,” a major barrier to deploying the test.

“I think a lot of people, myself included, think it’s very likely this virus might be circulating at low levels in the United States right now. We can’t know for sure because we haven’t seen it,” said Michael Mina, associate medical director of clinical microbiology at Brigham and Women’s Hospital. He said the optimal testing scenario for flu is a 30-minute turnaround on a test, but right now, shipping samples to Atlanta to test for coronavirus means a 48-hour wait.

“A lot of hospitals are trying to do something similar, which is get a test up and running on an instrument, get it validated in-house,” Mina said. “I think all of us are coming to the same realization that we can’t do anything as long as this remains under the control of CDC and state labs.”

Marion Koopmans, a virologist at the Erasmus University Medical Center in the Netherlands, which has performed a few hundred tests on behalf of more than a dozen countries, said that developing a test for a new pathogen is complicated and involves refinement and a back-and-forth between researchers who are constantly learning from one another.

“That is typical for a new disease outbreak. No one actually knows how this works, so you really have to build these assays on the fly,” Koopmans said.

But as the United States is still struggling to ramp up its capacity, the coronavirus test was added to the sentinel flu surveillance system in the Netherlands two weeks ago. The test was recently rolled out to 12 high-performing molecular diagnostic laboratories in the Netherlands so that they can be ready to scale up if demand increases.

Part of the problem in the United States is the tension between regulations intended to ensure a high-quality standard for tests and the need to roll out diagnostic capabilities very quickly. No test is perfect, and with high stakes for missing or misidentifying a case, public health officials want to make sure that tests are as accurate as possible and are validated by labs that run them. But the slowness may also reflect years of underinvestment in public health infrastructure — and a bias toward developing treatments that may seem more appealing to the public.

“The public health system is not sufficiently built to surge very rapidly,” said Luciana Borio, the former director of Medical and Biodefense Preparedness Policy at the National Security Council and now a vice president at In-Q-Tel, a strategic investor that supports the U.S. intelligence community. “Over the years, when given limited dollars, we applied it toward vaccines and therapeutics, more so than diagnostic tests. I think there’s this idea: The diagnostic test is not going to save my life. But the fact is they underpin so much of the response and deserve a lot more attention.”

[heartslogos]

the declassified texts of the inquisition’s elite [66]

(512): at the hospital. Kevin drank straight from the river

-

“Alright, I'll bite, who’s Kevin?” Cullen asks about five minutes into the silence following Leliana reading Mahanon’s latest text out loud. “And how many burner phones does Mahanon have that he can keep messaging you without using his official ones? I thought we only gave him one burner phone for this and it was for emergency life or death extraction only.”

“I’ve stopped asking about it. I’ve learned that it’s best that you also stop thinking about logistical questions such as that one when it comes to Mahanon and his resources,” Leliana says. “You’ll only give yourself a headache that only a disorienting sleep would be able to fix.”

“That’s very specific, Leliana,” Josephine replies, eyebrow raising. “Had to practice some of that recently?”

“Often, when Mahanon is concerned. I don’t get this much drama from my other agents. It’s like he’s the drama of an entire dorm of agents rolled into one,” Leliana says, “I can’t believe he wasn’t a person of interest before joining the Inquisition, what with all of the trouble that just seems to swarm towards him. He’s the urban equivalent of releasing Evelyn in a semi-wooded area, or putting Ellana anywhere that’s had at least one unexplained murder.”

“The first one is referencing the bears, yes?” Josephine asks, casting a quick glance at Cullen who nods in confirmation. “What does the latter refer to exactly?”

“If Ellana goes somewhere with at least one unexplained murder there is a very, very high chance that a second unexplained murder will occur or she will stumble upon a series of extremely disturbing crimes, creating a domino chain reaction that will lead us to a conspiracy,” Cullen explains. “So far we’ve uncovered four cults, one cannibal, three serial killers, and two cases of illegal experimentation.”

“The Inquisition’s only been around for three years, that seems extremely high.”

“Well, no, that’s her total for this year thus far. I don’t know her total from her start date to now,” Cullen quickly corrects Josephine, waving his hand, “Amiss of me, but one tends to lose track. It’s become expected at this point. I mean, no one keeps track of how many bear attacks Evelyn’s had.”

“That’s terrible,” Josephine makes a truly worried face, biting her lower lip. “I didn’t realize it was that high. I mean, I knew it was comically high.”

“It comes full circle, Josephine,” Cullen replies. “It starts off comical, takes a turn for extremely worrisome, then towards profoundly disturbing, and rounds off as comical again. Don’t worry about it. There isn’t anything we can do, after all. It’s just the way things are.”

“That’s a very calm approach for you, Cullen,” Leliana says, leaning back in her chair and giving him an appraising look. “How sensible. I’m impressed.”

“Oh, no,” Cullen laughs sheepishly, “This is the outlook I’ve taken towards our various friends’ and acquaintances’ idiosyncrasies. Towards most other things I’m still prone to worry, I’m afraid.”

“Good, because I was worried you might have been body snatched and I’d have to throw you into interrogation.”

“That’s a joke, right?”

Leliana just smiles. Cullen sighs.

“Back to discussing Mahanon’s current drama?” Josephine asks. “I have to admit, it’s quite grown on me. I’m perhaps a bit too invested in finding out what happens next in this story. It’s like a tele-novella or a very bad serial novel.”

“Like Varric’s novels, you mean?”

“Not all of his are terrible. Just…some. And that’s the point of them, I think. Some of them he writes badly on purpose. It’s satire.”

“Sure it is. Did he tell you that?”

“No, actually. He told me quite the opposite and thanked me for trying to have a higher opinion of him and offered to refund me for some of my subscriptions.”

“Noble of him, did you take him up on the offer?” Cullen asks.

“Of course not,” Josephine sounds scandalized at the thought, “I don’t regret a single penny spent. Please let’s get back to Mahanon for a moment? It’s such a refreshing break from.”

She pauses and indicates the array of files, computers, tablets, phones, and other such items cluttered around them.

And then she gestures vaguely outwards towards the rest of Skyhold.

“Well. You know. All of this.”

“The river Kevin drank from was most likely the one so polluted that Ferelden had to get it to flow backwards for their own safety,” Leliana explains.

“They what?” Josephine blinks. “How does one — backwards?”

“It’s not Ferelden as a whole who got it flowing backwards,” Cullen points out, quick to defend his former country. “It’s just one specific city in Ferelden, and by the time the issue went to court it was already done and there was no point in making a ruling over it.”

“I’m sure that the cities who just had the polluted river directed in their direction would disagree with you, Cullen.”

“Yes, well, they could just have the flow go back,” Cullen says. “There’s no one stopping them from doing that.”

“I forget you’re Fereldan sometimes,” Josephine says, shaking her head, “And then you say something like that and it hits me all at once.”

“I don’t see how anyone could forget, considering that Leliana takes great pains in reminding me at least once a day,” Cullen gives Leliana a mock glare. “Speaking of, I feel as though I’m do one right now.”

“It’s better when you don’t know it’s coming, Stanton. And no, that wasn’t it. I just like saying your middle name sometimes. It’s so very blonde.”

“I am blonde.”

“I know. Anyway, Kevin is Mahanon’s key witness, whom he is not yet done with extracting information from. One can only assume that Kevin drank the water out of some intrinsic instinct knowing that death would be better than living at Mahanon’s mercy, or maybe he was drugged. Or maybe just that stupid. It doesn’t matter. He drank the water and now he’s got to get his stomach pumped ASAP and possibly get some kind of fluid drip. Mahanon must be loving his life right now.”

[covid19updater]

COVID19 Updates: 08/25/2021

Spain:  Houston, we have a problem. Deaths in Madrid by age. Summer 2021 vs summer 2020, as of 24 Aug. At least, we seem to have a vaxx problem: More deaths and growing especially in the older/vaccinated groups and residences.

Philippines:  St. Luke's Medical Center on Wednesday announces  that its COVID-19 wards and critical care units are at full capacity.

RUMINT (Arkansas):  My husband who is a physician in Arkansas has been giving me the smallest fraction of grim information. Y'all need to be careful just walking around.

New York:  ALBANY, N.Y. (AP) — Gov. Kathy Hochul acknowledges nearly 12,000 more COVID-19 fatalities in NY than publicized by Cuomo administration.

US:  Latest @AmerAcadPeds report shows an alarming 48% rise in Covid-19 cases in kids —  180,175 from August 12 to 9 (up from 121,427 the previous week). Kids were 22.4% of weekly reported total cases. There were 24 new pediatric deaths.

China:  Golf-LPGA Tour cancels Shanghai tournament due to COVID-19 LINK

Sweden:  Sweden Prime minister Loefven resigns "we have failed with our special-way with Corona"

Tennessee:  16 y.o. Azorean Tatum, vaccinated high school student & football player at Westwood High School in Memphis #Tennessee died from COVID August 22, 2021. Mom believes he caught the virus at school. #SoulsLostToCovid LINK

Japan:  Two more athletes have tested positive for Covid-19 in the Paralympic village, with officials awaiting information to confirm if a cluster of infection has broken out, after a first case was discovered on Tuesday;

China:  Meanwhile, despite serious concerns over the efficacy of its domestically-made jabs, authorities in at least 12 Chinese cities have warned those who refuse to be vaccinated could be punished if found responsible for spreading the virus;

Israel:  COVID: What we know about the new Delta strain could lock Israel down LINK

World:  Should Long Covid be recognised as a disability? LINK

Australia:  NSW COVID IMPORTANT WARNING for some of the thousands of people in NSW now with COVID. If you are at home, and become breathless and dizzy .. call an ambulance. That's the warning from a Lung Specialist at a media conf now on @abcnews channel.

US:  BREAKING: More than 25,000 Americans in ICU with COVID-19, highest since pandemic began

US:  U.S. COVID update: Number in ICU at highest level since pandemic began - New cases: 149,090 - Average: 154,281 (-3,957) - In hospital: 98,674 (+2,931) - In ICU: 25,034 (+1,343) - New deaths: 1,343

Maryland:  “All members of the governor's staff are fully vaccinated,..” It appears we have another cluster of “extremely rare” breakthrough infections as 4 have tested positive.

Illinois:  Only one ICU bed available in southern IL region LINK

US:  Delta Air Lines calling the Delta Variant the B.1.617.2 Variant in their statement is one of the funniest corporate decisions ever.

UK:  NHS bracing for perfect storm winter disaster amid "Mass Exodus" of burnt-out staff. LINK

Maine:  Maine sees sharp increase in people hospitalized with COVID-19 LINK

Oregon:  JUST IN  In Oregon, people will now have to wear masks outdoor even if vaccinated, Governor says

World:  Officials, experts warn against using COVID-19 vaccine in kids under 12 LINK

US:  Covid: 85-90% of the U.S. must be vaccinated ‘if we’re going to get past this,’ warns Dr. Peter Hotez LINK

Texas:  Right now, the state is averaging 1,797 new "lab-confirmed COVID" hospital admissions each day, a new record high. The record for a single day is 1,907, set last Thursday.

Ohio:  Ohio reports highest daily COVID cases, hospitalizations, ICU admissions in months LINK

Mississippi:  For the first time since the pandemic began, Mississippi confirmed more than 100 new COVID-19 deaths in a single day's report. Today's 111 deaths reported surpasses the prior record of 98 deaths on Jan. 12, 2021. LINK

California:  After signs of leveling, COVID-19 hospitalizations in L.A. County tick back up LINK

Texas:  ‘Healthy’ 19-year-old got COVID. Now he faces ‘long-term ventilation,’ Texas family says LINK

US:  As Covid-19 cases spike US orders for monoclonal antibodies up 1200% LINK

World:  31 vaccinated choir members went on tour in Italy - 22 contracted corona

US:  Long Covid limbo: some US patients wait months for diagnosis and treatment LINK

UK:  Our Wednesday summary of English hospital activity sees all metrics increasing over the last week. Admissions have increased by (a slightly slower) 7% over the last week, and are now broadly back to the level seen in mid-July at the peak of the Euro-fuelled surge.

World:  JUST IN - Data on the benefits and safety of a #COVID19 vaccine booster shot is "inconclusive," says WHO Director General Tedros.

Florida:  In Florida, crematories are so overwhelmed with the deceased that bodies are “stacked to the ceiling”. There’s an influx of bodies like never seen before—worse than last year. Crematoriums in Orange County are begging for Florida to “supply some refrigeration”. @WFLA #COVID19

South Africa:  South Africa Reports Emergence Of New Worrisome SARS-CoV-2 Variant C.1.2 That Has Enhanced Transmissibility And Immune Evasion! - Thailand Medical News LINK

US:  BREAKING: More than 100,000 Americans are hospitalized with COVID-19

Iowa:  “Dept of Public Health has classified Covid-19 as endemic. Marion County PH (Iowa) Director Kim Dorn says: ‘It is endemic in the popn. What that means is it’s just expected to be there, kind of like the flu during flu season.. it’s not going to go away.”

Iowa:  Iowa currently ranks 3rd in the nation for %-positive Covid-19 tests at nearly 37%

World:  Study finds recent or current COVID-19 infection linked to increased risk of dangerous blood clots during surgery LINK

UK:  A very worrying trend in the UK Since the beginning of July, all-cause deaths have risen 12% over 2020 and 9% over the 2015-2019 average: 59,877 (2021) 53,435 (2020) 54,716 (2015-19 average) And the gap is widening. For the newest available week (Aug. 13) it was 16% over 2020.  This gap is not due to Covid deaths - though those are now also higher than last summer. Mortality is VERY seasonally predictable (see how close the 2015-19 average is to the 2020 figure). Something bad is going on.

US:  Biden Administration Plans Covid-19 Vaccine Boosters At Six Months Instead Of Eight LINK

Iowa:  7112 new COVID+ Iowans. This should not be confused with positive tests. That number is higher = 7619 positive tests. Some of the tests coming back positive are Iowans who had COVID already earlier in the pandemic.

Florida:  Florida’s COVID-19 resurgence: State reports 26,203 new cases, highest daily total of the pandemic

US:  Formal U.S. approval of the Pfizer/BioNTech COVID-19 vaccine will make it nearly impossible to successfully challenge mandates by employers, according to legal experts LINK

California: Los Angeles:  6,500 students in isolation/quarantine during first week of school LINK

Kentucky: Gov Andy Beshear:  Today I am sad to announce 65 deaths and 4,849 newly reported cases of COVID-19, the third highest report since the pandemic began. Of those cases, 1,518 are kids. Our positivity rate is the highest it’s ever been at 13.16% and hospitalizations have hit another record.

Colorado:  “An Unvaccinated Fitness Coach Thought COVID Antibodies [from his previous #Covid19 infection] Would Protect Him [against a second #Covid19 infection]. He Almost Died.” LINK

Texas:  NEW from @texastribune: COVID hospitalizations in Texas are approaching 14,000 — and an all-time high

Florida:  Tampa is treating tap water with bleach instead of liquid oxygen because hospitals need the chemical to keep ventilated COVID patients alive. They're also asking customers to "eliminate non-essential water uses." LINK

US:  #BREAKING: Disney Cruise Line will require proof of vaccination against COVID-19 for passengers sailing to The Bahamas next month LINK

Michigan: "There's lot of good guys out there ready to do bad things soon" -- an anti-masker goes ballistic at a Board of Commissioners meeting in Ottawa County, Michigan    LINK

World:  Largest safety study ever of Pfizer covid19 vaccine by @RanBalicer @mlipsitch et al on @NEJM LINK

Israel:  Wow. New Israeli preprint shows natural immunity to #SARSCoV2 is FAR superior to the artificial kind - vaccinated people were 13x as likely to be infected and 27x to have symptomatic infections as a matched cohort that was previously infected. And this is with Delta dominant.

Australia:  Two major hospitals in Sydney's west, the epicentre of Australia's coronavirus outbreak, set up emergency outdoor tents on Thursday to help deal with an increase in patients as the city grapples with its worst flare-up in the pandemic. Sydney, Australia's largest city, is struggling to stamp out an outbreak of the highly infectious Delta variant, with daily infections hitting record levels even after two months under a hard lockdown. LINK

World:  Human clinical trials begun for promising, llama-derived COVID antibodies LINK

New Zealand:  New Zealand reports 68 new coronavirus cases, the biggest one-day increase since April 2020.  NEW ZEALAND PM ARDERN: WE DON'T INTEND TO USE LOCKDOWNS FOREVER.

Australia:  Australia reports more than 1,000 new local Covid cases in 24 hours for the first time during the pandemic, as a Delta variant outbreak surges in Sydney

Texas:  Texas now within 300 patients of its all-time level of COVID hospitalizations. It has 306 ICU beds available in the entire state, per the Texas dashboard. 12 of the state's hospital regions have 5 or fewer ICU beds available; some have zero.

Israel:  Israel's grim COVID data suggests vaccines alone won't stop pandemic LINK

UK:  Covid in Scotland: Circuit-breaker lockdown among options to curb surge in cases LINK

US:  U.S. COVID update: Number in hospital reaches 100,000 - New cases: 186,782 - Average: 155,995 (+1,714) - In hospital: 100,592 (+1,918) - In ICU: 25,268 (+234) - New deaths: 1,340

California:�� California Assembly members not vaccinated against COVID-19 should be suspended, lawmaker says LINK

Japan:  NEW  Japan halts use of 1.63 million Moderna vaccine doses over contamination — vaccine have been found to contain foreign materials. - The Japan Times

[orbemnews]

Virus Variant First Found in Britain Now Spreading Rapidly in U.S. A more contagious variant of the coronavirus first found in Britain is spreading rapidly in the United States, doubling roughly every 10 days, according to a new study. Analyzing half a million coronavirus tests and hundreds of genomes, a team of researchers predicted that in a month this variant could become predominant in the United States, potentially bringing a surge of new cases and increased risk of death. The new research offers the first nationwide look at the history of the variant, known as B.1.1.7, since it arrived in the United States in late 2020. Last month, the Centers for Disease Control and Prevention warned that B.1.1.7 could become predominant by March if it behaved the way it did in Britain. The new study confirms that projected path. “Nothing in this paper is surprising, but people need to see it,” said Kristian Andersen, a co-author of the study and a virologist at the Scripps Research Institute in La Jolla, Calif. “We should probably prepare for this being the predominant lineage in most places in the United States by March.” Dr. Andersen’s team estimated that the transmission rate of B.1.1.7 in the United States is 30 percent to 40 percent higher than that of more common variants, although those figures may rise as more data comes in, he said. The variant has already been implicated in surges in other countries, including Ireland, Portugal and Jordan. “There could indeed be a very serious situation developing in a matter of months or weeks,” said Nicholas Davies, an epidemiologist at the London School of Hygiene and Tropical Medicine who was not involved in the study. “These may be early signals warranting urgent investigation by public health authorities.” Dr. Davies cautioned that U.S. data is patchier than that in Britain and other countries that have national variant monitoring systems. Still, he found results from some parts of the United States especially worrisome. In Florida, where the new study indicates the variant is spreading particularly quickly, Dr. Davies fears that a new surge may hit even sooner than the rest of the country. “If these data are representative, there may be limited time to act,” he said. Dr. Andersen and his colleagues posted their study online on Sunday. It has not yet been published in a scientific journal. When the British government announced the discovery of B.1.1.7 on Dec. 20, Dr. Andersen and other researchers in the United States began checking for it in American coronavirus samples. The first case turned up on Dec. 29 in Colorado, and Dr. Andersen found another soon after in San Diego. In short order it was spotted in many other parts of the country. But it was difficult to determine just how widespread the variant was. B.1.1.7 contains a distinctive set of 23 mutations scattered in a genome that is 30,000 genetic letters long. The best way to figure out if a virus belongs to the B.1.1.7 lineage is to sequence its entire genome — a process that can be carried out only with special machines. The C.D.C. contracted with Helix, a lab testing company, to examine their Covid-19 samples for signs of B.1.1.7. The variant can deliver a negative result on one of the three tests that Helix uses to find the coronavirus. For further analysis, Helix sent these suspicious samples to Illumina to have their genomes sequenced. Last month Helix reached out to Dr. Andersen and his colleagues to help analyze the data. Analyzing 212 American B.1.1.7 genomes, Dr. Andersen’s team concluded that the variant most likely first arrived in the United States by late November, a month before it was detected. Updated  Feb. 7, 2021, 11:07 a.m. ET The variant was separately introduced into the country at least eight times, most likely as a result of people traveling to the United States from Britain between Thanksgiving and Christmas. The researchers combined data from the genome sequencing with Helix’s overall test results to come up with an estimate of how quickly the variant had spread. It grew exponentially more common over the past two months. In Florida, the scientists estimate that more than 4 percent of cases are now caused by B.1.1.7. The national figure may be 1 percent or 2 percent, according to his team’s calculations. If that’s true, then a thousand or more people may be getting infected with the variant every day. The C.D.C. has recorded only 611 B.1.1.7 cases, attesting to the inadequacy of the country’s genomic surveillance. In parts of the country where Helix doesn’t do much testing, it is likely delivering an underestimate of the spread, Dr. Andersen cautioned. “It’s clearly not enough,” he said. “I can guarantee you that there are places where B.1.1.7 might be relatively prevalent by now that we would not pick up.” Nathan Grubaugh, a virologist at Yale University who was not involved in the new study, says the data makes it clear that the incidence of B.1.1.7 is increasing just as scientists warned it would. But he does not think the new study reveals exactly how it is growing. “It doesn’t really reveal the cause at this point,” he said. It’s possible that chains of B.1.1.7 transmission are spreading faster than other viruses. Or it might be that B.1.1.7 was more common among incoming travelers starting new outbreaks. “I still think that we are weeks away from really knowing how this will turn out,” Dr. Grubaugh said. The contagiousness of B.1.1.7 makes it a threat to take seriously. Public health measures that work on other variants may not be enough to stop B.1.1.7. More cases in the United States would mean more hospitalizations, potentially straining hospitals that are only now recovering from record high numbers of patients last month. Making matters worse, Dr. Davies and his colleagues at the London School of Hygiene and Tropical Medicine posted a study online on Wednesday suggesting that the risk of dying of B.1.1.7 is 35 percent higher than it is for other variants. The study has yet to be published in a scientific journal. Communities can take steps to fight variants like B.1.1.7, as Dr. Grubaugh and his Yale University colleagues recently described in the journal Cell. For instance, they said, health officials should reinforce messaging about wearing effective masks, avoiding large gatherings and making sure indoor spaces are well ventilated. The scientists also urged governments to require sick leave for people diagnosed with Covid-19 to stop workplace spread. “Such measures could help to significantly reduce community transmission,” Dr. Grubaugh and his co-authors wrote. Vaccinations can also be part of the strategy to fight B.1.1.7. In Israel, where the variant is now predominant, new cases, severe illnesses and hospitalizations have already dropped significantly in people over 65, a group that was given top priority for vaccines. “What we need to do with the current vaccines is get them into as many people as we can as quickly as possible,” Dr. Andersen said. Driving down B.1.1.7 will also reduce the risk that the variant will evolve into something even worse. Already in Britain, researchers have found samples of B.1.1.7 that have gained a new mutation with the potential to make vaccines less effective. It’s not clear whether these viruses will become common. But they demonstrate that the coronavirus has a lot of evolutionary space left to explore. “We should expect them to crop up here,” Dr. Andersen said. “Whatever was true elsewhere is going to be true here as well, and we need to deal with it.” Source link Orbem News #Britain #rapidly #Spreading #Variant #Virus

[bigyack-com]

They Recovered From the Coronavirus. Were They Infected Again?

Can people who recover from a bout with the new coronavirus become infected again — and again? The Japanese government reported this week that a woman in Osaka had tested positive for the coronavirus for a second time, weeks after recovering from the infection and being discharged from a hospital. Combined with reports from China of similar cases, the case in Japan has raised some uncomfortable questions. Reinfections are common among people who have recovered from coronaviruses that cause the common cold. But those pathogens are very different from the new coronavirus, and experts said it’s unlikely that these are cases of people getting infected a second time. “I’m not saying that reinfection can’t occur, will never occur, but in that short time it’s unlikely,” said Florian Krammer, a virologist at the Icahn School of Medicine at Mount Sinai in New York. Even the mildest of infections should leave at least short-term immunity against the virus in the recovering patient, he said. More likely, the “reinfected” patients still harbored low levels of the virus when they were discharged from the hospital, and testing failed to pick it up. Even if there were occasional cases of reinfection, they do not seem to be occurring in numbers large enough to be a priority at this point in the outbreak. Updated Feb. 26, 2020 What is a coronavirus? It is a novel virus named for the crownlike spikes that protrude from its surface. The coronavirus can infect both animals and people and can cause a range of respiratory illnesses from the common cold to more dangerous conditions like Severe Acute Respiratory Syndrome, or SARS. How do I keep myself and others safe? Washing your hands frequently is the most important thing you can do, along with staying at home when you’re sick. What if I’m traveling? The C.D.C. has warned older and at-risk travelers to avoid Japan, Italy and Iran. The agency also has advised against all nonessential travel to South Korea and China. Where has the virus spread? The virus, which originated in Wuhan, China, has sickened more than 80,000 people in at least 33 countries, including Italy, Iran and South Korea. How contagious is the virus? According to preliminary research, it seems moderately infectious, similar to SARS, and is probably transmitted through sneezes, coughs and contaminated surfaces. Scientists have estimated that each infected person could spread it to somewhere between 1.5 and 3.5 people without effective containment measures. Who is working to contain the virus? World Health Organization officials have been working with officials in China, where growth has slowed. But this week, as confirmed cases spiked on two continents, experts warned that the world was not ready for a major outbreak. A report published Thursday in JAMA supports the idea that people may test positive for the virus long after they seem to have recovered. In four medical professionals exposed to the virus in Wuhan, China, the epicenter of the epidemic, a test that detects the viral genetic material remained positive five to 13 days after they were asymptomatic. This does not necessarily mean that they were still able to infect others, however. The PCR diagnostic test is highly sensitive and can amplify genetic material from even a single viral molecule. As such, the test could merely be picking up fragments of the virus. PCR tests may detect remnants of the measles virus months after people who had the disease stop shedding infectious virus, Dr. Krammer said. The other possibility is that the negative test was done poorly, or the samples were stored at a temperature at which the virus deteriorates. The throat swab may also simply miss the virus that is hiding elsewhere in the body. “A virus test is positive if the virus was there on the swab in sufficient quantities at the time you swabbed the person,” said Marc Lipsitch, an epidemiologist at the Harvard T.H. Chan School of Public Health. “A negative test is not a definitive that there is no more virus in that person.” Dr. Lipsitch offered an analogy: a jam jar with mold on top. Scraping off the surface might give the impression that the jam is now mold-free, but in fact the jar may still contain mold that continues to grow. The Japanese woman initially had mild symptoms of coronavirus infection and tested positive in late January. She was released from the hospital on Feb. 1. She tested positive again on Wednesday after coming in for a sore throat and chest pain. “That certainly sounds like it could be an actual resurgence of the virus in infectious form,” Dr. Lipsitch said. But, he added, “Single anecdotes are really hard to interpret.” One worrisome possibility is that the coronavirus follows what is known as a biphasic infection: the virus persists and causes a different set of symptoms than observed in the initial bout. In patients infected with Ebola, the virus may persist for months in the testes or eyes even after recovery — and can infect others and keep the epidemic going. The recovered person, too, can develop other symptoms, including insomnia and neurological problems, said Angela Rasmussen, a virologist at Columbia University. “We don’t know if that’s the case with this coronavirus,” Dr. Rasmussen said. “We don’t know anything about this virus.” Coronaviruses are on the whole poorly understood, she said. Before the SARS epidemic, coronaviruses were not known to cause serious illnesses. Some scientists have said that people infected with the new coronavirus produce antibodies that will protect them in the future. And a single-patient report suggests that the immunity may last at least seven days. But this finding is neither surprising nor reassuring, said Dr. Stanley Perlman, a coronavirus expert at the University of Iowa. “The issue is whether you’ll see it in seven months or in a year,” he said. “That’s what you care about.” The new coronavirus closely resembles the ones that cause SARS and, to a lesser extent, MERS. There are no reports of reinfections with the SARS virus, Dr. Perlman said, and only one that he has heard of in a patient recovering from MERS. Dr. Perlman’s research with MERS has shown that the strength of the immune response depends on the severity of the infection, but that even in those with severe disease — which should produce the strongest immune responses — the immunity seemed to wane within a year. How long immunity lasts will also be a key question to resolve when designing a vaccine for the new coronavirus, particularly if the virus becomes a seasonal threat like influenza. “What is the nature of immunity to this virus after infection?” Dr. Lipsitch said. “That’s a research question that’s urgent.” Read the full article

[vinayv224]

Foreign intelligence operations are not meant to leave traces behind that could be used in a courtroom.

After nearly two years of investigation by Special Counsel Robert Mueller on what’s generally referred to as the question of collusion between Russia and Donald Trump’s presidential campaign, Attorney General William Barr has informed us in precisely worded language that Mueller “did not establish that members of the Trump Campaign conspired or coordinated with the Russian government in its election interference activities.”

There is interesting mystery and ambiguity in this statement, however, just as in any spy story.

A footnote in Barr’s letter says Mueller defined “coordination” as an “agreement — tacit or express — between the Trump campaign and the Russian government on election interference.” Note the three key elements: a tacit or express agreement, with the Russian government, about election interference.

The wording is important, particularly given how intelligence operations work. And so it is worth parsing this a bit, not only because Trump has declared this means he was exonerated, but also to highlight the lurking uncertainties at a moment when Congress is deciding how hard to press for direct access to the report itself, or at a minimum, to sworn testimony by Barr and Mueller about any hidden elements.

One of the core functions of the CIA, where I worked, is to carry out covert action. Covert action is defined as “a special activity abroad in support of foreign policy where the role of the US government is neither apparent nor publicly acknowledged.”

Both Barr’s letter and Mueller’s indictments make clear Russian intelligence services aimed to disrupt the 2016 election. Those intelligence operations against our democratic institutions, which persist, operate in similar ways to the aforementioned covert action. They are designed to support and advance Russia’s foreign-policy agenda while hiding the hand of the Russian government.

How does an intelligence service hide its government’s involvement? It does this by building into the operation what we call “plausible deniability” — more colloquially known as a cover story.

Remember in high school when you sent a friend over to the girl you liked to get a sense of whether she would go out with you if you asked? The friend could claim he was asking out of his own curiosity, to save you from embarrassment if the girl was uninterested. You could claim you never asked your friend to talk to the girl. The girl might guess you sent your friend, but she might not be able to prove it. That is plausible deniability. Your friend was acting as a “cutout” — to hide your involvement — with a cover story, that he was asking for his own curiosity.

In an intelligence operation, plausible deniability is a bit more sophisticated. Intelligence officers use individuals or businesses that are not part of the government but are, at arm’s length, working on behalf of the government as cutouts, and they can develop much more complex cover stories by using witting and unwitting foreign agents and front companies.

Another country’s intelligence services might be able to uncover some of these cutouts and cover stories. Using their own intelligence methods, they might collect information that points to the conclusion that a particular government is behind those cutouts and cover stories — a task that US intelligence agencies were able to accomplish not only in the case of the Russian influence operation but also in some notorious hacking incidents. Or they might not be able to do this, depending on how well the opposing service did its job. And even if the opposing service does leave some traces, the targeted country could still find it challenging to develop the sort of evidence that a prosecutor could bring to a courtroom.

Think of it like this: You’re a detective working on a murder case, and you come upon a safe that is smoking and smells of gunpowder. But without being able to open that safe, there is no way to say with certainty that a smoking gun sits inside.

The narrow wording of Mueller’s partial sentence that Barr quoted in his letter limits the question of coordination to a “tacit or express” agreement “with the Russian government.” Yet the Russians’ interventions — which aimed, in part, to help Trump win and to denigrate Hillary Clinton — were surely meant to hide those two elements. This wording leaves open the possibility that Mueller found plentiful coordination with others who were not part of the government but were a step, or several steps, removed.

A Russian lawyer such as Natalia Veselnitskaya, who has connections to the Kremlin but is not herself a member of the government, and who participated in a meeting with campaign officials where Russian dirt on Clinton was supposed to be shared, certainly fell into this category. And Mueller’s investigation and public reporting have surfaced a variety of other characters — such as Joseph Mifsud, Aras Agalarov, Rinat Akhmetshin, Konstantin Kilimnik, and Oleg Deripaska — who had some Kremlin connections without evidently being direct employees and who were in discussions with Trump campaign officials.

What does Mueller’s report actually say?

The bracket around the first letter of the Mueller quote is another small clue that more may be behind the curtain than we’ve been allowed to see so far. “[T]he investigation did not establish that the Trump campaign conspired or coordinated with the Russian government in its election interference activities.” The bracket around the T indicates there is a phrase that begins that sentence.

This, of course, is speculation, but the first part of that sentence — at one end of the spectrum — might be: “Although we detailed a number of troubling links between the Trump campaign and people associated with the Russian government, including links with worrisome national security implications, the investigation did not establish that the Trump campaign conspired or coordinated with the Russian government in its election interference activities.”

Alternatively, the first part of that sentence might also more reassuringly read: “After running every lead to the ground, the investigation did not establish that the Trump campaign conspired or coordinated with the Russian government in its election interference activities.”

But without seeing the actual report, we just don’t know. And given the public record of the Trump campaign’s contacts with many Russians and its officials’ repeated lies about those contacts, it is difficult to believe Mueller found nothing with national security implications.

Barr’s letter also states Mueller did not find anyone in the campaign who participated in the specific crimes of the Internet Research Agency influence operations or in the hacking and stealing of Democratic emails by Russian military officers.

But Barr’s letter does not address whether Mueller concluded that Trump or his associates were compromised by Trump’s efforts to build a Trump Tower Moscow, a project that required Russian government approval and was slated to net him hundreds of millions of dollars, at precisely the time the Russian government was running an intelligence operation aimed at helping him win the presidency.

Such a project might not amount to “tacit or express” coordination on “election interference,” but the overlapping timing of the campaign and the construction planning leaves open the possibility that Trump was vulnerable to manipulation. An intelligence asset might be unwitting — a “useful idiot,” as we say in the intelligence world — but that doesn’t diminish the threat that asset might be to national security, nor negate that he may actively have been used to some end.

The president’s son-in-law and senior adviser Jared Kushner told some interns in July 2017, for example, that the campaign was so disorganized or decentralized “we couldn’t even collude with our local offices,” according to Foreign Policy. But intelligence officers are skilled at gaining someone’s cooperation without them directly knowing what they are doing or why — and none of that sort of connivance would be readily prosecutable.

The language in Barr’s letter also does not address if Trump made an agreement to change US foreign policy — on issues such as the sanctions imposed over Ukraine — in order to get his coveted tower. Such an agreement would not fall under the narrow definition of “election interference” and would not even necessarily be illegal, but would still be a grave US counterintelligence concern.

A case that may not be black and white

None of this is to say Trump is a foreign agent under Vladimir Putin’s control. It’s important to know there is a gray area between “no collusion” and “Trump is a foreign agent.” We don’t know from what we’ve been able to read so far in whose interest he is acting. Even if he is acting in his own interest and solely on his own accord, many of his public actions (and we don’t know how many of his private actions) have fulfilled Russia’s overarching agenda of vilifying America’s institutions and hurting US national security. Supporting, and even publicly encouraging, a hostile foreign power to hack a former secretary of state’s emails is, to say the least, reckless. Mueller’s report likely would help put context to the many disturbing episodes we know about and help the public understand the nature of those meetings and relationships with Russians, from those at the lowest levels to Putin at the very top.

Importantly, Barr’s letter says Mueller’s investigation does back up the intelligence community’s overall findings that Russia interfered in the election, an idea Trump has consistently refused to accept. Furthermore, the letter confirms that “Russian-affiliated individuals” made “multiple offers” to assist the campaign. Notably, no one on the campaign ever reported those offers to the FBI and everyone consistently lied about them when asked. We need to discuss, as a nation, if this is acceptable for US politicians going forward. The standard of merely having “no criminal liability” is comically low for the position of US president; other, higher standards of ethics and morality should be discussed.

Because Russia’s interference in our democratic institutions involves covert action designed to hide the Russian government’s hand, drawing a conclusion about how successful Russia was with their many approaches to Trump and his team is difficult without access to the underlying intelligence that Mueller saw and the information gathered from more than 2,800 subpoenas, 500 search warrants, 230 orders for communication records, and nearly 50 orders to monitor phone call records. And given the nature of intelligence, coming as it does from classified sources and methods, we, the public, may never see it.

Even if we did, it might not rise to the level of criminality, which is why setting that bar was never going to be satisfactory. Many things intelligence officers from all countries get people to do are not illegal, but they can still be unethical or even dangerous to US security. Our laws also allow all kinds of unethical behavior at the nexus of money and politics.

In the end, the question comes down to this: Has the president faithfully executed the responsibilities of the office, free of untoward foreign influence? Without access to Mueller’s report, we cannot say for sure.

The only thing that Barr’s summary of Mueller’s report tells us for sure is that Mueller could not establish a “tacit or express” agreement with the Russian government as fact. That is, he did not feel he could prove it in court. This does not mean Mueller found no links between the Trump campaign and the Russian government’s actions.

While most have painted this partial sentence to mean Mueller found no evidence of collusion, it actually states Mueller could not find enough evidence to state conclusively, at a level that would stand up in court, that members of the Trump campaign coordinated with the Russian government.

Amid all the lingering questions, one thing is utterly clear from Barr’s summary: Until we see a fuller picture, the president’s “no collusion” victory lap feels premature.

Alex Finley (@alexzfinley) is the pen name of a former journalist and an officer of the CIA from 2003 to 2009, who is now writing analyses of Robert Mueller’s investigation. She is the author of Victor in the Rubble, a satire about the CIA and the war on terror. The Center for Public Integrity is a nonprofit, nonpartisan investigative journalism organization in Washington, DC.

from Vox - All https://ift.tt/2FwsbBr

[brajeshupadhyay]

Even Asymptomatic People Carry the Coronavirus in High Amounts

Of all the coronavirus’s qualities, perhaps the most surprising has been that seemingly healthy people can spread it to others. This trait has made the virus difficult to contain, and continues to challenge efforts to identify and isolate infected people.

Most of the evidence for asymptomatic spread has been based on observation (a person without symptoms nevertheless sickened others) or elimination (people became ill but could not be connected to anyone with symptoms).

A new study in South Korea, published Thursday in JAMA Internal Medicine, offers more definitive proof that people without symptoms carry just as much virus in their nose, throat and lungs as those with symptoms, and for almost as long.

“It’s important data, that’s for sure,” said Benjamin Cowling, an epidemiologist at the University of Hong Kong who was not involved in the work. “And it does confirm what we’ve suspected for a long time — that asymptomatic cases can transmit infection.”

Discussions about asymptomatic spread have been dogged by confusion about people who are “pre-symptomatic” — meaning they eventually become visibly ill — versus the truly asymptomatic, who appear healthy throughout the course of their infection.

The new study is among the first to clearly distinguish between these two groups.

“There’s been this big question pretty much since January, since data started coming out of China, about people that were asymptomatic or pre-symptomatic,” said Jason Kindrachuk, a virologist at the University of Manitoba who was not involved in the work. “What we haven’t really had any clue of yet is what role people who are asymptomatic play in transmission of disease.”

The new study measured the virus’s genetic material in the patients; the researchers did not follow the chain of transmission or grow live virus, which might have more directly confirmed active infections.

Still, experts said the results strongly suggest that asymptomatic people are unwitting broadcasters of the virus.

“They don’t look any different from the symptomatic population” in terms of how much virus they carry, said Marta Gaglia, a virologist at Tufts University in Massachusetts who was not involved in the work. “There’s no actual reason to believe a priori that they would transmit any differently.”

Dr. Cowling was more circumspect. Because asymptomatic people do not cough or sneeze, he said, it is possible that they are less efficient at expelling the virus than those who are clearly unwell.

On the other hand, Dr. Gaglia offered, people who feel ill tend to take to the bed or couch, whereas the infected but unaware may carry on with their business, sickening others along the way.

The South Korean team analyzed samples taken between March 6 and March 26 from 193 symptomatic and 110 asymptomatic people isolated at a community treatment center in Cheonan. Of the initially asymptomatic patients, 89 — roughly 30 percent of the total — appeared healthy throughout, while 21 developed symptoms.

The participants were mostly young, with a median age of just 25. (A study last week found that children, who are mostly mildly infected, also harbor at least as much virus as adults do.)

“The real strength of the study is they have a very large number of patients and they have very good follow-up,” Dr. Gaglia said. “When they talk about asymptomatic patients, they really, really know that these were true asymptomatics.”

The study’s estimate that 30 percent of infected people never develop symptoms is in line with findings from other studies. In a television interview on Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, tendered 40 percent as the figure.

“The good news about Covid-19 is that about 40 percent of the population have no symptoms when they get infected,” Dr. Fauci said. But “even though you are likely not going to get symptoms, you are propagating the outbreak, which means that you’re going to infect someone, who will infect someone, who then will have a serious consequence.”

The participants in the new study were all isolated when they tested positive for the virus and did not have the opportunity to infect others. Doctors and nurses tracked their temperatures and other symptoms, and tested their sputum — which indicates virus present in the lungs — as well as their noses and throats.

“Both groups had similar amounts of virus pretty much throughout the entire course of infection,” Dr. Kindrachuk said. Asymptomatic people became virus-free a little sooner: around Day 17, compared with Day 19 or 20 for those with symptoms.

The Coronavirus Outbreak ›

Frequently Asked Questions

Updated August 6, 2020

Why are bars linked to outbreaks?

Think about a bar. Alcohol is flowing. It can be loud, but it’s definitely intimate, and you often need to lean in close to hear your friend. And strangers have way, way fewer reservations about coming up to people in a bar. That’s sort of the point of a bar. Feeling good and close to strangers. It’s no surprise, then, that bars have been linked to outbreaks in several states. Louisiana health officials have tied at least 100 coronavirus cases to bars in the Tigerland nightlife district in Baton Rouge. Minnesota has traced 328 recent cases to bars across the state. In Idaho, health officials shut down bars in Ada County after reporting clusters of infections among young adults who had visited several bars in downtown Boise. Governors in California, Texas and Arizona, where coronavirus cases are soaring, have ordered hundreds of newly reopened bars to shut down. Less than two weeks after Colorado’s bars reopened at limited capacity, Gov. Jared Polis ordered them to close.

I have antibodies. Am I now immune?

As of right now, that seems likely, for at least several months. There have been frightening accounts of people suffering what seems to be a second bout of Covid-19. But experts say these patients may have a drawn-out course of infection, with the virus taking a slow toll weeks to months after initial exposure. People infected with the coronavirus typically produce immune molecules called antibodies, which are protective proteins made in response to an infection. These antibodies may last in the body only two to three months, which may seem worrisome, but that’s perfectly normal after an acute infection subsides, said Dr. Michael Mina, an immunologist at Harvard University. It may be possible to get the coronavirus again, but it’s highly unlikely that it would be possible in a short window of time from initial infection or make people sicker the second time.

I’m a small-business owner. Can I get relief?

The stimulus bills enacted in March offer help for the millions of American small businesses. Those eligible for aid are businesses and nonprofit organizations with fewer than 500 workers, including sole proprietorships, independent contractors and freelancers. Some larger companies in some industries are also eligible. The help being offered, which is being managed by the Small Business Administration, includes the Paycheck Protection Program and the Economic Injury Disaster Loan program. But lots of folks have not yet seen payouts. Even those who have received help are confused: The rules are draconian, and some are stuck sitting on money they don’t know how to use. Many small-business owners are getting less than they expected or not hearing anything at all.

What are my rights if I am worried about going back to work?

What is school going to look like in September?

It is unlikely that many schools will return to a normal schedule this fall, requiring the grind of online learning, makeshift child care and stunted workdays to continue. California’s two largest public school districts — Los Angeles and San Diego — said on July 13, that instruction will be remote-only in the fall, citing concerns that surging coronavirus infections in their areas pose too dire a risk for students and teachers. Together, the two districts enroll some 825,000 students. They are the largest in the country so far to abandon plans for even a partial physical return to classrooms when they reopen in August. For other districts, the solution won’t be an all-or-nothing approach. Many systems, including the nation’s largest, New York City, are devising hybrid plans that involve spending some days in classrooms and other days online. There’s no national policy on this yet, so check with your municipal school system regularly to see what is happening in your community.

Both estimates are much longer than the period of isolation required in most countries, Dr. Gaglia noted. The Centers for Disease Control and Prevention recently decreased the recommended isolation for infected people without symptoms to 10 days from 14.

Several studies have suggested that infected people shed — or pass into the environment — live coronavirus for only about a week, even though the tests may pick up viral fragments in their bodies for much longer.

Dr. Cowling also noted that the study was retrospective, meaning the researchers looked at samples collected from people who had tested positive earlier, instead of following a group of people over time, identifying everyone who became infected as well as their contacts, and assessing their symptoms and virus levels.

“It would still be valuable to design a study like that,” he said. Still, he conceded that comparing people with symptoms and without was challenging because infected people are found in varying ways.

Most testing plans focus on people who need medical care, and rarely whole groups regardless of symptoms — especially in places like the United States, where tests are often scarce to begin with.

A lack of testing can also influence how much asymptomatic people contribute to the size of an outbreak.

With enough testing, everyone found to be infected could be separated from others. But if the testing is barely enough to catch the visibly ill, then asymptomatic people — particularly the young and social — may fan out into society and keep the virus circulating at high levels.

Many other viruses can be spread by people without symptoms, usually at negligible levels, Dr. Kindrachuk said.

It’s still unclear whether the new coronavirus is unusual in this respect, able to spread widely from asymptomatic people, he added, or whether it just seems so prolific because of the scale of the pandemic. Studies addressing those questions are underway.

“There are all these small nuances about this virus that are coming to light each day,” Dr. Kindrachuk said.

The post Even Asymptomatic People Carry the Coronavirus in High Amounts appeared first on Shri Times News.

via Blogger https://ift.tt/3fF8reW

[stephenmccull]

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Email Sign-Up

Subscribe to KHN’s free Morning Briefing.

Sign Up

Please confirm your email address below:

Sign Up

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire published first on https://smartdrinkingweb.weebly.com/

[gordonwilliamsweb]

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Email Sign-Up

Subscribe to KHN’s free Morning Briefing.

Sign Up

Please confirm your email address below:

Sign Up

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire published first on https://nootropicspowdersupplier.tumblr.com/

[dinafbrownil]

As Problems Grow With Abbott’s Fast COVID Test, FDA Standards Are Under Fire

In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test that for weeks had received high praise from the White House because of its speed: Test results could be wrong.

The agency at that point had received 15 “adverse event reports” about Abbott’s ID NOW rapid COVID test suggesting that infected patients were wrongly told they did not have the coronavirus, which had led to the deaths of tens of thousands of Americans. The warning followed multiple academic studies showing higher “false negative” rates from the Abbott device, including one from New York University researchers who found it missed close to half of the positive samples detected by a rival company’s test.

But then, in a move that confounded lab officials and other public health experts, a senior FDA official later that month said coronavirus tests provided outside lab settings would be considered useful in fighting the pandemic even if they miss 1 in 5 positive cases — a worrisome failure rate.

The FDA has now received a total of 106 reports of adverse events for the Abbott test, a staggering increase. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an agency spokesperson said.

In a statement, Abbott Laboratories said the NYU research was “flawed” and “an outlier,” citing studies with higher accuracy rates.

Email Sign-Up

Subscribe to KHN’s free Morning Briefing.

Sign Up

Please confirm your email address below:

Sign Up

Though the Abbott rapid test is one of over 100 COVID-19 diagnostic tests to receive FDA emergency use authorization during the pandemic, President Donald Trump has featured the product in the White House Rose Garden and the Health and Human Services Department’s preparedness and response division has issued more than $205 million worth of contracts to buy the test, according to federal contract records.

“Everybody was raving about it,” a former administration official said, speaking on the condition of anonymity to discuss internal deliberations. “It’s an amazing test, but it has limitations which are now being better understood.”

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95% of positive samples.

But medical professionals are split over the lower 80% threshold for the Abbott and other point-of-care tests’ “sensitivity” — a metric showing how often a test correctly generates a positive result. They are debating whether it’s sufficient, given the risks that an infected person unwittingly spreads COVID-19 after receiving a negative result.

False negatives increase the risk that patients will not self-isolate or exercise other precautions — such as wearing a mask — and make more people sick than if they had had an accurate diagnosis. Evaluations of the Abbott test have been among the most mixed, with some researchers finding that the test has bigger accuracy problems, but others saying it isn’t likely to miss sicker patients.

“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center. Whittier and co-authors found that the Abbott test correctly identified 74% of positive samples compared with a rival test from Roche, another diagnostics giant. A point-of-care test from Cepheid, a rival company, correctly identified 99% of positives.

An FDA official cited the 80% accuracy minimum for point-of-care tests in late May even after two White House aides tested positive for the virus. The Executive Office of the President has spent roughly $140,000 on Abbott test kits, according to contract records.

In a statement, Abbott said when its test is used as intended it “is delivering reliable results and is helping to reduce the spread of infection in society by detecting more positive results than would otherwise be found.” Studies from University Hospitals Cleveland Medical Center and OhioHealth found that its test detected at least 91% of positives.

In March, HHS officials announced that Cepheid would receive approximately $3.7 million through its Biomedical Advanced Research and Development Authority for coronavirus diagnostic development work; the Strategic National Stockpile also made a one-time $2.3 million purchase of Cepheid’s point-of-care tests, according to an agency spokesperson.

“Knowing the true performance of such a point-of-care test and knowing that it may be less sensitive than a central lab molecular test is important, but also can play a role in triaging patients who are suspected of having COVID-19,” Dr. Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said on the call when discussing the Abbott warning. “If we are able to determine that sensitivity of the assay in controlled trial circumstances is at least 80%, we feel like that test has a valuable place going forward in this pandemic.”

Until the FDA can complete post-market studies to verify performance, he said, negative results with the Abbott rapid test will be treated as “presumptive” negatives.

Despite that note of caution, governors were also told during a June 3 call with Vice President Mike Pence that the fast Abbott test should be used to test residents and staff in long-term care settings, according to two sources with knowledge of the discussions. As of May 31, more than 95,000 people in nursing homes have tested positive for COVID-19 and nearly 32,000 have died, according to the Centers for Medicare & Medicaid Services. If 20% of tests are false negatives, personnel with COVID-19 could be going about their normal activities, spreading the virus.

Spokespeople for Pence did not respond to requests for comment.

No test is perfect, whether it’s for a common illness like the flu or for COVID-19, which has killed nearly 120,000 Americans. Federal officials contend that the trade-off with point-of-care tests — especially ones as fast as Abbott’s, which can turn around a positive result in as little as five minutes and a negative one in 13 minutes — is that the tests can be used in spots where traditional lab tests aren’t as accessible. There’s also a greater risk of operator error when administering the test in the real world given the way patient specimens are collected and handled.

An FDA spokesperson said officials’ “general expectation” is that companies’ test validation data indicate a sensitivity of at least 95%; however, “based on the available information, FDA has issued EUAs [emergency use authorizations] to some tests that presented data indicating a sensitivity below 95%.”

“Rapid and reliable detection of positive patients can be important for public health,” the spokesperson said.

Cepheid would not comment on FDA’s 80% standard but pointed to a Northwell Health Laboratories study finding its test was 98% accurate in detecting positives. The company has shipped approximately 6 million tests since getting FDA authorization in March.

“Experience has shown that in COVID testing, pre-analytical variables such as the site of sample collection (nasal, nasopharyngeal, throat, saliva) and the quality of the sample collected can have a large impact on test performance,” Dr. David Persing, Cepheid’s chief medical and technology officer, said in a statement. “Tests with higher sensitivity have a natural advantage in this setting.”

As far as Abbott’s test, “there are certainly some elements of it that could be improved, but I think it’s a great assay,” said Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, who said the NYU study was “flawed” in part because of the number of patients researchers included with such low viral loads that they wouldn’t be infectious. An NYU spokesperson has defended the research.

Mina and others also took issue with the FDA’s threshold.

“For them to just say 80%, it lets people game the system,” he said. Companies presented with a single figure for sensitivity could manipulate which patients they test to exceed the minimum — for example, by including only very sick patients, which most tests would have an easier time detecting as a positive.

“They really need to fix this issue,” Mina said.

Abbott has already made several revisions to its materials for how its test should be performed. It removed prior language in its instructions saying swabs could be placed in a type of liquid — known as viral transport medium — before the test is run because doing so caused patient specimens to be too diluted. Now, the company says only direct swabs from patients should be inserted into the machine. It also revised its instructions for handling patient specimens following a KHN story in which lab professionals voiced safety concerns.

Christopher Polage, the medical director of Duke University Health System’s clinical microbiology lab, said experts have known for years that point-of-care tests are not as good at identifying known positives, but there are still legitimate situations in which they are used clinically.

“The difference now,” he said, “is that people are so fearful and tolerance for false negatives is just zero.”

Abbott’s rapid COVID-19 test isn’t the only point-of-care test to receive FDA authorization during the pandemic, but Trump has touted it the most by far, hailing the speed at which results can be given. To date, Abbott has delivered more than 3.6 million of the rapid tests to customers in all 50 states, including urgent care clinics, physicians’ offices, the federal government and hospital emergency departments.

In Washington, D.C., the city government has distributed 11 Abbott testing instruments across homeless shelters, jails, long-term care facilities, a clinic that largely serves lower-income Latinos and two public hospitals in the district’s poorest neighborhoods. Mobile testing units were also equipped with five Abbott machines, using them to test 40 to 50 people per site mostly at long-term care facilities, according to city officials.

The district has not found that the Abbott test has a higher rate of false negatives compared to other tests, said Dr. Jenifer Smith, director of the city’s Department of Forensic Services, which oversees the city’s public health lab.

“We test every test before we put it online,” she said. “We didn’t find the successively high rate of false negatives. In fact, we found we were getting the same results.”

But several labs have found the test with the presidential seal of approval to be less accurate than some of its competitors in detecting known positives.

“Without confirmation of negatives, I wouldn’t want to use it in hospitals,” said Gregory Berry, director of molecular diagnostics at Northwell Health Laboratories in New York. Berry co-authored the analysis finding that the Abbott ID Now test detected nearly 88% of positive samples compared with 98% from Cepheid, whose point-of-care test takes 45 minutes. Abbott contested the findings of the Northwell and Columbia papers because it said the tests were run in a way that diluted the specimens.

Berry and other lab personnel also said that a key metric Abbott reported as part of the process for receiving FDA authorization — known as the limit of detection, which specifies how little of the virus is needed for the test to reliably detect it — doesn’t match up with their own findings, and, in at least one instance, by a huge margin. A higher limit of detection means more viral material is needed for the test to detect the coronavirus. And a higher limit of detection increases the risk of false-negative results if a patient’s viral burden isn’t high.

Berry’s analysis determined that the lowest quantity of the virus needed to identify 100% of positive cases was 20,000 copies per milliliter. Abbott’s self-reported standard is a fraction of a percent of that.

Abbott said the limit of detection it provided to the FDA is accurate.

Of Abbott’s stated limit, Polage said: “I’m not sure what they were thinking.”

from Updates By Dina https://khn.org/news/abbott-rapid-test-problems-grow-fda-standards-on-covid-tests-under-fire/

[day0one]

At Senate Hearing, Government Experts Paint Bleak Picture of the Pandemic

WASHINGTON — Two of the federal government’s top health officials painted a grim picture of the months ahead on Tuesday, warning a Senate panel that the coronavirus pandemic was far from contained, just a day after President Trump declared that “we have met the moment and we have prevailed.”

The officials — Dr. Anthony S. Fauci, the nation’s top infectious disease expert, and Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention — predicted dire consequences if the nation reopened its economy too soon, noting that the United States still lacked critical testing capacity and the ability to trace the contacts of those infected.

“If we do not respond in an adequate way when the fall comes, given that it is without a doubt that there will be infections that will be in the community, then we run the risk of having a resurgence,” said Dr. Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, who is at the forefront of efforts to find a coronavirus vaccine.

Sign Up For the Morning Briefing Newsletter

If states reopen their economies too soon, he warned, “there is a real risk that you will trigger an outbreak that you may not be able to control,” which could result not only in “some suffering and death that could be avoided, but could even set you back on the road to trying to get economic recovery.”

Dr. Fauci’s remarks, during a high-profile — and partly virtual — hearing before the Senate Committee on Health, Education, Labor and Pensions, along with those of Dr. Redfield, made clear that the nation had not yet prevailed.

Bing COVID-19 tracker: Latest numbers by country and state

They appeared to rattle the markets, driving the S&P 500 down as investors weighed the potential of a second wave of infections against Mr. Trump’s promises that the economy would bounce back once stay-at-home restrictions were lifted. Worrisome reports of spikes in infections in countries like China, South Korea and Germany, where lockdowns had been lifted, seemed to confirm the American officials’ fears.

Here in Washington, Dr. Fauci and Dr. Redfield, who have been barred by the White House from appearing before the Democratic-controlled House, drew a very different picture of the state of the pandemic than the president, who has cheered for a swift reopening, championed protesters demanding an end to the quarantine and predicted the beginning of a “transition to greatness.”

Dr. Fauci told senators that coronavirus therapeutics and a vaccine would almost certainly not be ready in time for the new school year, that outbreaks in other parts of the world would surely reach the United States and that humility in the face of an unpredictable killer meant erring on the side of caution, even with children, who have fared well but have recently shown new vulnerabilities.

Dr. Redfield pleaded with senators to build up the nation’s public health infrastructure, even as he acknowledged that the C.D.C. had not filled 30 jobs authorized by Congress last year to expand its capacity to track outbreaks, and had yet to put in place a “comprehensive surveillance” system to monitor outbreaks in nursing homes, which have been hard hit by the pandemic.

“We are not out of the woods yet,” he said, “but we are more prepared.”

The two were among four government doctors — the others were Dr. Stephen Hahn, the commissioner of food and drugs, and Adm. Brett P. Giroir, an assistant secretary for health ��� who testified remotely during the hearing. Senator Lamar Alexander, Republican of Tennessee, who like Dr. Fauci, Dr. Redfield and Dr. Hahn is in quarantine after being exposed to the coronavirus, presided as the committee’s chairman from his home in Maryville, Tenn.

The doctors’ downbeat assessments came as the death toll in the United States surpassed 81,000 — a figure that Senator Tim Kaine, Democrat of Virginia, noted was “45 times the rate of South Korea.” The hearing, titled “Covid-19: Safely Getting Back to Work and Back to School,” offered little concrete advice on how that would happen. It was the first chance lawmakers have had to publicly question the officials in Congress since Mr. Trump declared a national emergency two months ago — and to do so without Mr. Trump standing nearby.

Despite the gloomy predictions for the months ahead, the experts drew a somewhat more upbeat picture over the long term. Asked by Senator Mitt Romney, Republican of Utah, if the scientists would ultimately develop a vaccine, Dr. Fauci said: “It’s definitely not a long shot, Senator Romney. I would think that it’s more likely than not that we will.”

And Admiral Giroir assured Senator Bernie Sanders, independent of Vermont, that his office was determined to see to it that a vaccine “reaches all segments of society regardless of their ability to pay.”

Some Republicans sounded their own upbeat note. Mr. Alexander proclaimed testing in the United States “impressive” and “enough to begin going back to work.” Senator Mike Braun, Republican of Indiana, agreed, saying in an interview, “I have great optimism that we won’t backslide.”

But the sentiment was not universal. Mr. Romney drew an unfavorable comparison between South Korea, which conducted 140,000 tests by March 6 and has had 258 deaths from Covid-19, and the United States, which had conducted about 2,000 tests by March 6.

“I find our testing record is nothing to celebrate,” Mr. Romney said.

For Dr. Redfield, who has largely been sidelined by Mr. Trump — at least in the administration’s public response — the hearing was a rare opportunity to speak directly to Americans, though he often seemed at pains not to showcase any disagreements with the president. Dr. Fauci, one of the most visible federal health officials and voices in the pandemic, has had less frequent appearances at the podium the past two weeks, since Mr. Trump abandoned his daily coronavirus task force briefings. Often the subject of speculation that the president will fire him, Dr. Fauci reassured senators that their relationship was intact.

“There is certainly not a confrontational relationship between me and the president,” he said, adding that when he gives Mr. Trump advice, “he hears that, he respects it, he gets opinions from a variety of other people.”

The hearing scene was extraordinary. The wood-paneled hearing room, in the Dirksen Senate Office Building, was set up with tables along all four walls, so senators — some of whom were wearing masks that they removed while speaking — could sit a reasonable distance apart. Those who participated virtually gave viewers a peek into their private lives. Senator Patty Murray of Washington, the top Democrat on the panel, appeared beside a pine cabinet in her home office. Mr. Alexander’s dog, a Cavalier King Charles spaniel named Rufus, slept in the background as he spoke.

The mood was at times tense. Mr. Alexander put Democrats on notice not to engage in “finger pointing” and insisted that “even the experts underestimated Covid-19.” Ms. Murray followed that by calling Mr. Trump’s response “a disaster,” adding: “The president isn’t telling the truth. We must, and our witnesses must.”

Across the Capitol, House Democrats on Tuesday unveiled a $3 trillion economic stimulus measure to respond to the pandemic, including $1 trillion in aid to state, local and tribal governments, another round of $1,200 direct payments to American families, and more money for jobless aid and food assistance.

Ms. Murray used her time to make a pitch for the package, saying Republicans — who have already joined with Democrats in approving nearly $3 trillion in government aid — had not done enough.

“What good is a bridge that only gets you to the middle of the river?” she asked.

There were flash points between the witnesses and the senators, as well. In one sharp exchange, Senator Rand Paul, Republican of Kentucky, pressed his belief that children needed to return to school and told Dr. Fauci that his voice was not the only one senators would listen to.

“I think we ought to have a little bit of humility in our belief that we know what’s best for the economy,” Mr. Paul said. “And as much as I respect you, Dr. Fauci, I don’t think you’re the end-all. I don’t think you’re the one person who gets to make a decision.”

Dr. Fauci replied, “We should be humble about what we don’t know.” But, he continued, “we really better be very careful, particularly when it comes to children,” because new research is showing that they may not be “completely immune to the deleterious effects” of Covid-19.

The White House has put out guidelines for states to follow, called “Opening Up America Again,” in planning how to reopen businesses and get people back to work and school. The plan recommends, among other things, that before reopening, states should have a “downward trajectory of positive tests” or a “downward trajectory of documented cases” of the coronavirus over two weeks, while conducting robust contact tracing and “sentinel surveillance” testing of asymptomatic people in vulnerable populations, like nursing homes.

But the guidelines are not mandatory, and many states are reopening without adhering to them, seeking to ease the pain as millions of working people and small-business owners are facing economic ruin while sheltering at home.

Senator Christopher S. Murphy, Democrat of Connecticut, complained on Tuesday that Dr. Fauci and the other witnesses were “trying to have it both ways” by saying that states should not reopen too early while giving governors guidance that was “criminally vague.” The C.D.C. has been working on a more specific plan that has been held up by the White House. Mr. Murphy demanded to know when it would be released — especially given that states were reopening.

“Is it this week? Is it next week?” the senator asked. Dr. Redfield replied that the guidance would be on the C.D.C.’s website “soon,” after being reviewed by Mr. Trump’s coronavirus task force.

“Soon isn’t terribly helpful,” Mr. Murphy shot back.

[bountyofbeads]

A FAULTY CDC CORONAVIRUS TEST DELAYS MONITORING OF DISEASES SPREAD

By Carolyn Y. Johnson, Laurie McGinley and Lena H. Sun | Published February 25 at 1:00 PM EST | Washington Post | Posted February 25, 2020 |

Problems with a government-created coronavirus test have limited the United States’ capacity to rapidly increase testing, just as the outbreak has entered a worrisome new phase in countries worldwide. Experts are increasingly concerned that the small number of U.S. cases may be a reflection of limited testing, not of the virus’s spread.

While South Korea has run more than 35,000 coronavirus tests, the United States has tested only 426 people, not including people who returned on evacuation flights. Only about a dozen state and local laboratories can now run tests outside of the Centers for Disease Control and Prevention in Atlanta because the CDC kits sent out nationwide earlier this month included a faulty component.

U.S. guidelines recommend testing for a very narrow group of people — those who display respiratory symptoms and have recently traveled to China or had close contact with an infected person.

But many public health experts think that in light of evidence that the disease has taken root and spread in Iran, Italy, Singapore and South Korea, it’s time to broaden testing in the United States. Infectious disease experts fear that aside from the 14 cases picked up by public health surveillance, there may be other cases, undetected, mixed in with those of colds and flu. What scares experts the most is that the virus is beginning to spread in countries outside China, but no one knows whether that’s the case in the United States, because they aren’t checking.

“Coronavirus testing kits have not been widely distributed to our hospitals and public health labs. Those without these kits must send samples all the way to Atlanta, rather than testing them on site, wasting precious time as the virus spreads,” said Senate Minority Leader Charles E. Schumer (D-N.Y.).

In a congressional hearing Tuesday, Sen. Patty Murray (D-Wash.) pressed Health and Human Services Secretary Alex Azar on whether the CDC test was faulty. He denied that the test did not work.

But in a news briefing that was going on about the same time, Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, said that she was “frustrated” about problems with the test kits and that the CDC hoped to send out a new version to state and local health departments soon.

“I think we are close,” she said. She said that the agency is working as fast as possible on the tests, but that the priority is making sure they are accurate.

Currently, she said, a dozen state and local health departments can do the testing, although positive results need to be confirmed by the CDC. She also said she hoped that tests from commercial labs would soon come online.

Messonnier said the agency was weighing widening its testing protocols to include people traveling to the United States from countries beyond mainland China, considering the rapid spread of the virus in other places in recent days.

The nation’s public health laboratories, exasperated by the malfunctioning tests in the face of a global public health emergency, have taken the unusual step of appealing to the Food and Drug Administration for permission to develop and use their own tests. In Hawaii, authorities are so alarmed about the lack of testing ability that they requested permission from the CDC to use tests from Japan. A medical director at a hospital laboratory in Boston is developing an in-house test, but is frustrated that his laboratory won’t be able to use it without going through an onerous and time-consuming review process, even if demand surges.

“This is an extraordinary request, but this is an extraordinary time,” said Scott Becker, the chief executive of the Association of Public Health Laboratories, which is asking the FDA for permission to allow the laboratories to create and implement their own laboratory-developed tests.

At one hospital in the Mid-Atlantic region, a patient who recently returned from Singapore, which has 90 cases, was admitted to the hospital with mild upper respiratory symptoms, according to a hospital official who spoke on the condition of anonymity to protect the patient’s privacy. The patient tested negative for flu. Because of underlying medical conditions, the person was at higher risk for severe illness if this was a coronavirus infection.

Even though clinicians suspected coronavirus, and treated the person for it and placed the patient in isolation, the patient was not tested.

“If this person had returned from mainland China, they would have been tested for coronavirus,” the official said. The patient recovered and was discharged to their home.

Testing also affects other aspects of care.

People with confirmed cases can enroll in clinical trials for therapeutics. For patients who need more intense care in a facility with a biocontainment unit, that facility can receive reimbursement from the federal government for care, the official said.

The CDC announced a week and a half ago that it would add pilot coronavirus testing to its flu surveillance network in five cities, a step toward expanded testing of people with respiratory symptoms who didn’t have other obvious risk factors. Specimens that test negative for flu will be tested for coronavirus. But that expanded testing has been delayed because of an unspecified problem with one of the compounds used in the CDC test. About half of state labs got inconclusive results when using the compound, so the CDC said it would make a new version and redistribute it.

To public health experts, the delays — and lack of transparency about what, exactly, is wrong with the test — are extremely concerning.

“We have over 700 flights every month between Hawaii and Japan or South Korea,” where the virus is spreading in the community, said Hawaii Lt. Gov. Josh Green, who is also an emergency physician. It’s unlikely that the CDC would allow state labs to accept a test from another nation, he said, but “this is an exceptional circumstance.”

In a letter to the FDA, the Association of Public Health Laboratories, which represents state and local laboratories, asked the agency to use “enforcement discretion” to allow the laboratories to create and use their own laboratory-developed tests.

“While we appreciate the many efforts underway at CDC to provide a diagnostic assay to our member labs … this has proven challenging and we find ourselves in a situation that requires a quicker local response,” said the letter, which was co-signed by Becker. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories.”

Because a public health emergency has been declared, certified hospital laboratories that usually have the ability to internally develop and validate their own tests can’t use them without applying for an “emergency use authorization,” a major barrier to deploying the test.

“I think a lot of people, myself included, think it’s very likely this virus might be circulating at low levels in the United States right now. We can’t know for sure because we haven’t seen it,” said Michael Mina, associate medical director of clinical microbiology at Brigham and Women’s Hospital. He said the optimal testing scenario for flu is a 30-minute turnaround on a test, but right now, shipping samples to Atlanta to test for coronavirus means a 48-hour wait.

“A lot of hospitals are trying to do something similar, which is get a test up and running on an instrument, get it validated in-house,” Mina said. “I think all of us are coming to the same realization that we can’t do anything as long as this remains under the control of CDC and state labs.”

Marion Koopmans, a virologist at the Erasmus University Medical Center in the Netherlands, which has performed a few hundred tests on behalf of more than a dozen countries, said that developing a test for a new pathogen is complicated and involves refinement and a back-and-forth between researchers who are constantly learning from one another.

“That is typical for a new disease outbreak. No one actually knows how this works, so you really have to build these assays on the fly,” Koopmans said.

But as the United States is still struggling to ramp up its capacity, the coronavirus test was added to the sentinel flu surveillance system in the Netherlands two weeks ago. The test was recently rolled out to 12 high-performing molecular diagnostic laboratories in the Netherlands so that they can be ready to scale up if demand increases.

Part of the problem in the United States is the tension between regulations intended to ensure a high-quality standard for tests and the need to roll out diagnostic capabilities very quickly. No test is perfect, and with high stakes for missing or misidentifying a case, public health officials want to make sure that tests are as accurate as possible and are validated by labs that run them. But the slowness may also reflect years of underinvestment in public health infrastructure — and a bias toward developing treatments that may seem more appealing to the public.

“The public health system is not sufficiently built to surge very rapidly,” said Luciana Borio, the former director of Medical and Biodefense Preparedness Policy at the National Security Council and now a vice president at In-Q-Tel, a strategic investor that supports the U.S. intelligence community. “Over the years, when given limited dollars, we applied it toward vaccines and therapeutics, more so than diagnostic tests. I think there’s this idea: The diagnostic test is not going to save my life. But the fact is they underpin so much of the response and deserve a lot more attention.”

*********

[oswald-hanciles-posts]

THE OSWALD HANCILES COLUMN (July 25th 2019 edition)

PONDER MY THOUGHTS BY Andrew KeiliPRES. BIO: “THE REPORTS OF MY DEATH ARE GREATLY EXAGGERATED.” Who wants our President dead? Well, President Bio should not be unduly worried as he is in good company as we learn later in this article. The fact is that conspiracy theorists also abound.I, more than most people acknowledge that conspiracy theorists are in our midst. One of my uncles in my village of Baiima prevailed on my dad to open a shop for him. Unfortunately, he got his two rascally sons to run the shop, which obviously ran at a loss as things kept disappearing. He was made to believe by his sons that his neighbor across the road, another relative had “Indian magic” and made things disappear from the shop with a wave of the hand. This was the story line he had for us when we visited on holidays. The neighbour had one ear clipped off during an altercation with someone on the train, who chewed off one of his ears and the half ear was very noticeable. My uncle was explaining this “Indian magic” phenomenon to me on one occasion when the neighbour popped up in his front verandah in his “bobani”, yawned and stretched his arms up-obviously out of tiredness. “You see what I was telling you, Karmoh”, my uncle exclaimed. What?, I asked. He hid behind the door, peeped through a small door opening and touched his ear as if he was going to clip it- obviously calling my attention to the neighbor with the clipped ear. “Shhhh-He is signaling again. More things are going to disappear soon”, he tried to convince me. No matter what my protestations were, he kept insisting the neighbour had “Indian magic”. The poor neighbour did not even notice he had such powers! The sons emptied the shop in no time and that was the end of the business!The way some people try to convince others that the President is sick is worrisome. It has been going on for quite a while and more recently the rumour has got translated to death. There was a time when the rumour mill was rife with talk that President Kabbah had died when he was in office. President Koroma also endured “many sicknesses” and “near deaths”. But why do people wish our leaders dead? Why the false news and exaggeration? In May 1897, the great American humorist, novelist and social critic Mark Twain was in London. It was one of the stops on a round-the-world speaking tour he’d embarked on in 1895. He hoped to use the fees from speaking engagements to pay off the considerable debts he owed in the United States, due to a series of unsuccessful investments and publishing ventures. While Twain was in London, someone started a rumor that he was gravely ill. It was followed by a rumour that he had died. According to a widely repeated legend, one major American newspaper actually printed his obituary and, when Twain was told about this by a reporter, he quipped: “The reports of my death are greatly exaggerated.”   The story is also told of Northeastern University political economy professor Barry Bluestone who found himself quickly eating his words after publicly wishing death on President Trump. During a lecture about the rule of law and inequality in the U.S., Bluestone told his students, “Sometimes I want to just see him impeached. Other times, quite honestly — I hope there are no FBI agents here — I wouldn’t mind seeing him dead." The video was posted on YouTube, causing controversy for the private Massachusetts-based university. Northeastern quickly issued a statement to the Boston Globe condemning the video. “The university and its leaders steadfastly oppose violence in all its forms,” the statement read. ……As a result, we have decided to take down the video of this event.” Realizing that the university didn’t back him and that his 17-year career at the school may be at risk, Bluestone attempted to conduct some quick damage control, calling his comments “stupid”. "What I should have said is, ‘I would love to see him disappear, I’d like him out of the White House,’” Poland's leading Archbishop deplored comments by a senior conservative priest who had wished Pope Francis a quick death if he does not open to "wisdom." Krakow Archbishop Marek Jedraszewski said he heard about the comments with "great pain and regret". In his speech, Staniek, who is a prominent theologian, said he was praying for wisdom for Francis and a "heart open to the Holy Spirit, and if he does not do that, for a quick passage to the House of the Father," meaning death. He said that Francis has departed from the teaching of Jesus and was wrongly interpreting mercy as opening up to Muslims and allowing communion for divorced Catholics, who, according to the church, live in mortal sin and are not allowed communion. Nigeria has had its share of Presidential deaths and “exaggerated deaths”. From the reality of death for Sani Abacha and Yar’Adua to the constant rumours about President Buhari, the rumour mill has always churned. In the case of Abacha, one columnist quipped “Till now, we cannot tell with confirmed certainty if it was liver cirrhosis that killed Abacha or the mysterious “Indian escorts.” In Buhari’s case the President’s spokesmen constantly talked about his  “annual vacation” and “medical trip” to the United Kingdom. As rumours swirled about the President’s death, one supporter wrote: “Those who want the President dead are malevolent souls who are still sore Buhari defeated their candidate in the 2015 election”.Let’s come back to our own President. Seriously, why would anyone want our President dead? Rumours have swirled a while about him not being well, only to find out that he robustly copes with his punishing schedule. It would seem this time the rumour went from sickness to death. The situation was not helped by the President’s spokesmen keeping mute on his whereabouts. Rumours were rife that he was in a hospital in London.  When nobody could trace our President, the Deputy High Commissioner in the UK muddied the waters, lending credence to the maxim “silence is golden”. No doubt the Press release was puerile and further raised suspicions.The Release started with- “This is to inform all that our President Julius Maada Bio is very Well and Hearty.  He is only relaxing and enjoying a little break from his very hectic schedule in London.”. She might as well have said “Our President is chilling!”  It continued- “VP The Honourable Mohamed Juldeh Jalloh is holding the fort and he knows that the President is very well and fit and that there is nothing to worry about.”. Why for goodness sake was the VP brought into the equation? “There is nothing to worry about” reminds one of the Krio statement attributed to a thief -“Una lef me, a nor go run away”.  Suspicions were further raised. Then the press release went for the jugular of detractors- “It is unfortunate that some people are still bent on spreading lies. It is unfortunate that the rumour is said to come from the High Commission. I can authoritatively state that it just a figment of someone’s imagination and nothing else.” Come to think of it, Governor Clarkson’s prayer could have come in handy here! Non-government commentators like Dr Sylvia Blyden seemed to tell us more about the President’s whereabouts in Kenya-with pictures and all, than any government spokesperson. Anyway, all is well that ends well. Someone said, “Being a good Catholic, he resurrected from the dead three days later in Kenya”. We were all pleased that our President was vacationing with his family in Kenya and even had time to discuss ways of promoting tourism and boosting trade between Kenya and Sierra Leone with the Kenyan President.The President’s media team has not covered itself on this issue with glory. There is nothing wrong for the President and family to go on vacation, especially with his recent punishing schedule of local and international travels. Many others have also legitimately questioned his spate of overseas visits with a coterie of government functionaries to a host of countries and wondered about the costs and benefits to the nation. This is always fair comment that  his spokesmen have an obligation to address. A President is not judged by the number of trips he makes to foreign countries. There are legitimate questions to be asked-“Does he bring home the bacon?. “Is he running to stay in the same place?”. When there is a news blackout, the rumour mill takes over. Such rumour mongering may be a response to the failures of the government to properly communicate with people. When people cannot get reliable official information, they make up their realities and hawk them around until they acquire some truth value.One Nigerian columnist writing on such an issue opined: “Until our leaders learn to preempt rumours by making their health conditions public information, they will expend themselves putting out fires. In the post-truth world, rumours and fact-free truths travel the world without a visa and debunking them, unfortunately, sometimes assert their validity.”I wonder the point of rejoicing at someone’s death when none of us is beyond mortality. Death is one of life’s many realities. We must instead pray for our leaders. Nowhere is prayer more needed than for the leaders of our government and nation. Whether your prayer is for the President, Parliament or the Judges of our land, they need prayer support. Even our Policemen!No matter who is leading our country as President, we offer our prayers on behalf of his/her position. I rather like this prayer I have edited for our President after all this death wish. “Almighty God, thank You for our President who has pledged his life in service to our country. Give him a true servant spirit. Anoint him with the Holy Spirit’s power, that he might feel Your strength in every situation. Let integrity and honesty guide every decision as He first looks to You for divine help. Turn his heart from distractions and temptations that could bring harm rather than help to his life, his family, and to the people he serves. Make him a leader in every respect, morally and spiritually strong. Enlighten his mind with discernment, wisdom, and fairness. When others tempt him to embrace arrogant power rather than humble service, give him an undivided heart. Help him to stand firm, knowing that You will fight his battles with him. As You surround him with godly counselors, give him accountability to them and the people he serves, but first and foremost to You. Bless him with joy when righteousness and goodness prevail. But give him a heart that weeps for the injustices and sorrows around him. Guard our President against unfair criticism and unfounded accusations. When he stumbles, give him the courage to admit his mistakes. Strengthen his character, guard him against hurtful compromise, and give him a listening ear for the people he serves. In danger, surround him and our country with Your angel protection. From the time he begins in office until his time is complete, may he serve you and our country as a true leader with an undying love, an unswerving faith, and an unending hope in the only One who can make our country great.Amen” The death of our President is greatly exaggerated. Let us pray for him that he may lead us with discernment, wisdom and fairness. Ponder my thoughts lled from SLAVE SHIP-FREEDOM SHIP Group 1 forum ☝🏾Posted by Engineer Andrew Keili in SLAVE SHIP-FREEDOM SHIP Group 3 forum. (Engineer Andrew Keili has over 20 years as a mining engineer in the diamond and titanium industries in Sierra Leone.  After the RUF rebels attacked the Sierra Rutile mining where he was working in 1996, Andrew Keili joined two other veteran  mining engineers  - Alex Kamara; and Tani Pratt  - to establish the engineering consultancy, CEMMATS. CEMMATS has grown up to be incomparably successful in Sierra Leone; clinching engineering contracts in African and Asian countries; providing employment for hundreds of Sierra Leoneans over the past twenty years.   Andrew Keili was an aspirant for the SLPP candidacy a couple of years ago. He failed there!Andrew Keili was Vice Presidential candidate to the candidacy of Kande Yumkella of the NGC in the 2018 presidential election.  He failed there!!Methinks, Engineer Andrew Keili should just eschew politics and stick to writing where his talent obviously shines. I pause, Oswald Hanciles, The Guru.  July 25, 2019 12:40 hours in Freetown, Sierra Leone When I grow up, I will want to be an excellent a writer as Engineer Andrew Keili!! Look for the three best Sierra Leonean writers today and Andrew Keili will be one of them.   Andrew Keili is probably the best columnist in Sierra Leone today! (Of course, that does NOT include "The Guru" - of THE OSWALD HANCILES COLUMN  -  in that contest!!💪🏾💪🏾). Andrew Keili writes his wisdom, and profundity with captivating wit.  'Nar Andrew Keili wan grain normore sabi cuss man pan ee article dem and di cussed would applaud him! The downside of Andrew Keili's writings is that he is always too nuanced; using a surgeon's scalpel even when a butcher's axe would be  necessary.  But, then, what would you expect of this son of the first non-Krio bishop  of the preeminent Krio church in Sierra Leone? I pause, Oswald Hanciles, The Guru.   July 25, 2019 12:24 hours in Freetown, Sierra Leone