COVID-19 News

[Gunky]

The FDA should not have caved to Trump’s latest covid-19 demand

More of the same dangerous stuff, an ignorant fool who keeps insisting that he knows better than all the doctors, scientists and researchers. Why the entire country is not up in arms over this idiot sticking his oar in every five minutes and managing to fuck up the response at every turn, I'll never know. It's not just that he is wrong, often dangerously so. He should not be interfering in medical matters affecting the health and safety of all of us! No president should do that but especially not an undisciplined, chaotic, shambling moron who listens to chance acquaintances (and above all moronic talking heads on Fox News - Trump's cable cabinet) and decides to substitute their opinions for the science being offered by the experts. Why is that so hard to comprehend?

 

[Tranquility]

The FDA should not have caved to Trump’s latest covid-19 demand

More of the same dangerous stuff, an ignorant fool who keeps insisting that he knows better than all the doctors, scientists and researchers. Why the entire country is not up in arms over this idiot sticking his oar in every five minutes and managing to fuck up the response at every turn, I'll never know. It's not just that he is wrong, often dangerously so. He should not be interfering in medical matters affecting the health and safety of all of us! No president should do that but especially not an undisciplined, chaotic, shambling moron who listens to chance acquaintances (and above all moronic talking heads on Fox News - Trump's cable cabinet) and decides to substitute their opinions for the science being offered by the experts. Why is that so hard to comprehend?

Part of the charm of Trump is that he breaks through the regulatory barriers enacted in non-pandemic times. Obviously, some don't find the charm. I take it you disagree that it was a good thing to get the plasma treatments out there now rather than wait for testing. That's fine. There are other programs out there too that are acting similarly. There is the U.S. program called "warp speed" that is designed/hoped to bring about a vaccine faster than ever accomplished in human history. Part of that program is the removal of regulatory barriers all the doctors, scientists and researchers have put in place.

Is that a good thing or a bad thing?

-------------------------
A pretty good description of a study on antibody guideline issues:
New guidelines say coronavirus antibody tests are pointless
An interesting insight in the article mentions that, because of how the antibodies can seem to disappear over time, there won't be any "immunity pass" type of identifications based on an antibody test.

The guidelines are at:
Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serologic Testing
Recommendations

• Recommendation 1: The IDSA panel suggests against using serologic testing to diagnose SARS-CoV-2 infection during the first two weeks (14 days) following symptom onset (conditional recommendation, very low certainty of evidence).
• Recommendation 2: When SARS-CoV-2 infection requires laboratory confirmation for clinical or epidemiological purposes, the IDSA panel suggests testing for SARS-CoV-2 IgG or total antibody three to four weeks after symptom onset to detect evidence of past SARS-CoV-2 infection (conditional recommendation, very low certainty of evidence).
  • Remark – When serology is being considered as an adjunct to NAAT for diagnosis, testing three to four weeks post-symptom onset maximizes the sensitivity and specificity to detect past infection.
  • Remark – Serosurveillance studies should use assays with high specificity (i.e., >99.5%), especially when the prevalence of SARS-CoV-2 in the community is expected to be low.
• Recommendation 3: The IDSA panel makes no recommendation either for or against using IgM antibodies to detect evidence of past SARS-CoV-2 infection (conditional recommendation, very low certainty of evidence).
• Recommendation 4: The IDSA panel suggests against using IgA antibodies to detect evidence of past SARS-CoV-2 infection (conditional recommendation, very low certainty of evidence).
• Recommendation 5: The IDSA panel suggests against using IgM or IgG antibody combination tests to detect evidence of past SARS-CoV-2 infection (conditional recommendation, very low certainty of evidence).
  • Remark – IgM or IgG combination tests are those where detecting either antibody class is used to define a positive result.
• Recommendation 6: The IDSA panel suggests using IgG antibody to provide evidence of COVID-19 infection in symptomatic patients with a high clinical suspicion and repeatedly negative NAAT testing (weak recommendation, very low certainty of evidence).
  • Remark – When serology is being considered as an adjunct to NAAT for diagnosis, testing three to four weeks post-symptom onset maximizes the sensitivity and specificity to detect past infection.
• Recommendation 7: In pediatric patients with multisystem inflammatory syndrome, the IDSA panel suggests using both IgG antibody and NAAT to provide evidence of current or past COVID-19 infection (strong recommendation, very low certainty of evidence).
• Recommendation 8: The IDSA panel makes no recommendation for or against using capillary versus venous blood for serologic testing to detect SARS-CoV-2 antibodies (knowledge gap).

 

[Siebter]

Part of that program is the removal of regulatory barriers all the doctors, scientists and researchers have put in place.

Like they did in Russia?

Is that a good thing or a bad thing?

Bad thing.

 

[Tranquility]

Like they did in Russia?



Bad thing.

Obviously not like they did in Russia. Otherwise, we'd have dozens of vaccines already. However, there is risk.

Just as there is risk to not having a vaccine at warp speed. Remember, it's not just inventing it, it is manufacturing and distributing it as well.

I remember when we discussed Japanese experiments in WWII data in school. I was rather appalled at NOT using the data as, while horrific and in no way should have been gathered, it was data and was useful to Science!. It was explained that it is of greater benefit to show the world we won't use data gathered immorally than it would be to use the data to help people. It's like that here too.

The choice is between if we will offer a treatment in a pandemic to sick people with no other choice or to give 1/2 of the people we choose to be in a study the treatment. If the treatment is of higher benefit than risk, we're making a similar moral choice as we did with the Japanese data albeit coming to a different conclusion. (In that we accept the death of some to help the greater good.) Of course, if the risk is of higher benefit than the benefit, we have Science! to thank for not putting those who would have gotten the treatment otherwise at risk.

I think we all accept we will balance the risk/reward to effective treatment differently if we're talking about ourselves or our mother against the greater good than against some random guy we don't even know versus it. But, don't tell me we need to wait years for the clinical trials to complete before we can use it to fight the disease in very sick people.

As to the warp speed vaccine, I can go either way as well. As I wrote earlier, the first vaccine through phase III trials is probably going to be the vaccine with the least effect. Going fast in getting the vaccine is not necessarily the best path. However, once it is found and determined to be the one to manufacturer, I hope we can quickly ramp up making and distributing it and would need to see what is proposed in regulatory relief to see if I agree. Most who look at it think it a good thing.

 

[macbill]

California: Crazy Enough For You?

Anti-masker ‘Karen’ is physically dragged out of store after assaulting and pepper-spraying people

A video uploaded to Twitter this Saturday shows a woman being physically dragged out of a California supermarket after she became violent when she was asked to wear a mask, according to the person who uploaded the video.


WTF is wrong with people? It’s like everybody’s social filters died in a grievous stroke

 

[Gunky]

California: Crazy Enough For You?

Anti-masker ‘Karen’ is physically dragged out of store after assaulting and pepper-spraying people

A video uploaded to Twitter this Saturday shows a woman being physically dragged out of a California supermarket after she became violent when she was asked to wear a mask, according to the person who uploaded the video.


WTF is wrong with people? It’s like everybody’s social filters died in a grievous stroke

Wouldn't it be great to have a leader who enthusiastically pushed for mask use and modeled the proper behavior personally? I wonder if we could have avoided all these batshit incidents...

 

[Siebter]

@Tranquility – Well, if you ask me, those „regulatory barriers all the doctors, scientists and researchers have put in place” are there for a reason. It's not like in the past we were not interested in using medical solutions of any kind as quick as possible – but focusing on this aspect alone (and scientist all around the world already do so much more than it is common btw) has some drawbacks we have to keep in check.

Just as a side note: it's interesting that for „Operation Warp Speed“ they chose a name that may sound cool, but also describes a principle that when it comes to science is just not possible.

Edit:

WTF is wrong with people? It’s like everybody’s social filters died in a grievous stroke

It's quite amazing indeed.

 

[Gunky]

@Tranquility – Well, if you ask me, those „regulatory barriers all the doctors, scientists and researchers have put in place” are there for a reason. It's not like in the past we were not interested in using medical solutions of any kind as quick as possible – but focusing on this aspect alone (and scientist all around the world already do so much more than it is common btw) has some drawbacks we have to keep in check.

Just as a side note: it's interesting that for „Operation Warp Speed“ they chose a name that may sound cool, but also describes a principle that when it comes to science is just not possible.

-snip-

The thing is you can administer a potential vaccine to animals and then to several people and get encouraging results. This, by the way, is the point where you know who starts screaming what's the harm let's deploy it. The difficulty at that point is: we have not yet established that the vaccine doesn't kill more people than it saves. If, for example, it turns out that one out of every thousand getting this dies, then it's not a slam dunk. This is a pretty important distinction, one that very likely will fly right over the head of you know who. That is why it is very, very dangerous to let an unscrupulous person who desperately wants to save himself from electoral defeat improperly push to deploy a vaccine, or any medicine, too early and before the proper trials have been done.

And if you don't think he would gamble your life on the chance that it would help him win re-election you haven't been paying attention.

 

[florduh]

We Still Don't Know All the Long-Term Consequences of 'Mild' COVID-19

Surviving COVID-19 is one thing. Becoming healthy again is another. Recent studies have found that even people who didn’t seem to have life-threatening cases show signs of damage to their heart. We don’t know what the future has in store for them.

While I’m thinking specifically about this study from Germany showing heart damage in 80% of the patients examined, there are other clues that there’s a large, murky gray area on the spectrum of illness in between dying and surviving unscathed.

For example, we’ve known for a while that even patients who have cleared the infection and tested negative twice may have lingering symptoms, leaving them officially “recovered” but hardly feeling that way.

 

[Tranquility]

Science!
Recommendations for Investigational COVID-19 Convalescent Plasma

 

[florduh]

Science!
Recommendations for Investigational COVID-19 Convalescent Plasma

So if these guidelines are followed, this may not be a bad thing. My concern with an EUA was that we don't know the best way to make blood plasma work. The best way to find out is conducting randomized trials, where some get the plasma and some get a placebo. An EUA that allows any patient access wouldn't allow us to know how, at what point, or even if plasma treatments work.

That having been said, it's hard to argue against allowing critically ill patients access to treatment, which is what the FDA guidelines call for. But if it turns into a free for all where any patient can request it regardless of how severe their symptoms are... I worry it will greatly muddy the waters for understanding how to most effectively employ convalescent plasma, (or as the President calls it "plahhs-mah").

 

[Tranquility]

So if these guidelines are followed, this may not be a bad thing. My concern with an EUA was that we don't know the best way to make blood plasma work. The best way to find out is conducting randomized trials, where some get the plasma and some get a placebo. An EUA that allows any patient access wouldn't allow us to know how, at what point, or even if plasma treatments work.

That having been said, it's hard to argue against allowing critically ill patients access to treatment, which is what the FDA guidelines call for. But if it turns into a free for all where any patient can request it regardless of how severe their symptoms are... I worry it will greatly muddy the waters for understanding how to most effectively employ convalescent plasma, (or as the President calls it "plahhs-mah").

You mean if we actually look at the facts it was not an orangemanbad shitshow?

Can't be true.

 

[macbill]

Trump supporters in Ohio are trying to impeach GOP Gov. DeWine for trying to prevent the spread of coronavirus

Ohio Gov. Mike DeWine is among the Republican governors who has been applauded by medical experts for his response to the coronavirus pandemic and implementing social distancing measures in his state. But some Republicans in Ohio’s state legislature believe that DeWine committed an unforgivable sin by trying to slow down the spread of COVID-19 in his state and are calling for his impeachment.

==========================================================================================
Ammon Bundy dragged out of Idaho capitol in handcuffs after arrest

On Tuesday, Boise reporter Ryan Suppe tweeted images of far-right activist Ammon Bundy being dragged out of the Idaho state capitol in handcuffs, after storming the building in protest of mask mandates.

 

[macbill]

No, the Coronavirus Didn’t Kill Corona Beer

The Corona/coronavirus thing was mostly a worry that never materialized. There were a small, small number of people who seemed to consider a connection between the beer and the pandemic for more than a few seconds, but mostly it was fodder for “man on the street” interviews at local TV stations.

==========================================================================================
Almost 50 North Texans Drank Bleach This Month, Poison Center Warns ‘Stop, It Won’t Cure COVID’

Following 46 cases of bleach ingestions in the North Texas Poison Center region since the start of August, experts are again warning people that drinking the chemical won’t prevent COVID-19.

 

[florduh]

Why America’s COVID Testing Is Trash

The United States is still experiencing one of the worst COVID-19 outbreaks of anywhere in the world. And much of that is because many of our communities still haven’t been able to answer one fundamental question: Who has the virus?

Efficient testing would have allowed us to identify superspreaders early on in the pandemic, but now, with so much community spread, it’s a little late to expect testing will help us get out in front of the virus. We still don’t have enough tests, but according to Robinson Meyer, who covers the pandemic for the Atlantic, there is a way we could fix our testing system on a mass scale that might help us get the pandemic under better control, even before a vaccine is made available....

...What this epidemiologist at Harvard, Michael Mina, is calling for is the development and government-funded mass production of rapid tests, which exist right now. They don’t require special machinery; they’re just a paper strip. You would spit on it, put it in a cup, and wait 10 minutes. It would tell you whether you’re infectious right now, delivering a result within 15 minutes.

What Mina says is we should produce these things in the billions at public expense and then make them freely available to anywhere in the country. And then, before you go into a public place like a movie theater, restaurant, school, or office, you take one of these tests. If it’s negative, you’re allowed to proceed. If it’s positive, you go home and wait. He argues that if we had a testing strategy on that scale, we’d be able to bring the virus to heel within three weeks.

 

[Tranquility]

A nice compilation of the Hydroxycloriquine studies coming in.

https://c19study.com/

 

[florduh]

Dexamethasone and Hydroxychloroquine: Why Randomized Controlled Trials Matter

How we know hydroxychloroquine doesn’t have any beneficial effect on COVID-19

David Gorski and other contributors have written numerous posts over the past several months regarding hydroxychloroquine from its anecdotal beginnings based on Chinese hypotheses to observational trials that were published in France. I refer you to those excellent posts if you’re interested in the politics, posturing, and bad arguments in favour of its use. I want to show you why there is now convincing evidence that hydroxychloroquine is ineffective, by looking past the (methodologically) weaker trial designs, and summarizing the six largest, most rigorously conducted trials. Five of these trials have been published, and one is available in pre-print only. (Thank you to Dr. Perry Wilson for the helpful list on Twitter.) Here are the findings and links so you can peruse the research yourself:

1. In patients admitted to a hospital with mild-to-moderate COVID-19 and randomized to hydroxychloroquine or a placebo for 2-3 weeks, there was no difference in terms of improvement (measured by checking if the body had eliminated the virus) at the 28 day point. [Ref: BMJ 2020; 369:m1849]
2. After exposure to someone with COVID-19, patients were randomized to hydroxychloroquine or placebo for five days. There was no difference in terms of the subsequent rate of infections. The hydroxychloroquine group experienced more side effects. [Ref: N Engl J Med 2020; 383:517-525]
3. Non-hospitalized patients with confirmed COVID-19 and less than five days of symptoms were randomized to hydroxychloroquine or placebo for one week. There was no difference in terms of the reduction of viral load, the risk of hospitalization, or the time to resolution of symptoms. [Ref: Clinical Infectious Diseases 2020; ciaa1009]
4. In non-hospitalized adults with confirmed COVID-19 or probable COVID-19, patients were randomized to hydroxychloroquine or placebo for five days. There was no difference in overall symptom severity over 14 days. The hydroxychloroquine group experienced more side effects. [Ref: Ann Int Med 2020; doi.org/10.7326/M20-4207]
5. In hospitalized patients with suspected or confirmed COVID-19 who were receiving supplemental oxygen, patient were randomized to usual care, usual care plus hydroxychloroquine, or usual care plus hydroxychloroquine and azithromycin. There was no difference between the groups in terms of clinical status at day 15. [Ref: N Engl J Med 2020; DOI: 10.1056/NEJMoa2019014]
6. In a preprint article (not yet peer-reviewed), hospitalized patients with COVID-19 were randomized to hydroxychloroquine for 10 days or until discharge, versus usual care. There was no difference with respect to 28 day mortality, but the hydroxychloroquine group had an increased duration of hospital stay and an increased risk of progressing to ventilation or death. [Ref: medRxiv 2020; doi 10.1101/2020.07.15.20151852]

The table is not every RCT, and more RCTs will undoubtedly emerge. But prospectively conducted rigorous trials give a consistent picture: hydroxychloroquine does not have any meaningful effects on the prevention or treatment of COVID-19 infections.

 

[Gunky]

-snip-
The table is not every RCT, and more RCTs will undoubtedly emerge. But prospectively conducted rigorous trials give a consistent picture: hydroxychloroquine does not have any meaningful effects on the prevention or treatment of COVID-19 infections.

Whaddya know, Fauci and all those other health authorities weren't engaged in a giant conspiracy to cover up an effective treatment after all when they said this has no proven benefit. Who woulda thunk it?

 

[macbill]

Yay!
Moderna COVID-19 vaccine appears to work as well in older adults in early study

Moderna Inc (MRNA.O) said on Wednesday its experimental COVID-19 vaccine induced immune responses in older adults similar to those in younger participants, offering hope that it will be effective in people considered to be at high risk for severe complications from the coronavirus.

 

[Gunky]

The C.D.C. was pressured to change guidance on testing asymptomatic people who had been exposed to the virus.
The Centers for Disease Control and Prevention was instructed by higher-ups in the Trump administration to modify its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus, according to two federal health officials.

One official said the directive came from the top down. Another said the guidelines were not written by the C.D.C. but were imposed, Sheryl Gay Stolberg reports.

https://www.nytimes.com/2020/08/26/world/covid-19-coronavirus.html#link-75471d37

Same shit, different day. As with so many other things, this president can't keep his short little fingers off our federal response to the virus. He interferes with medical authorities same as he interferes with women. "When you are a star they let you get away with it." Now he is fucking with all of us. Damn right I'm angry! You don't have to be a genius to understand what they are doing here: lowering the official number of new cases by testing less in an attempt to aid the president's re-election. "So I told my people: slow the testing down!" Scum! Murderers.

Andrew Cuomo
@NYGovCuomo
6h
The CDC reversed its guidance to say that people in close contact with a COVID-positive person don't need to get tested. This is not science. It’s politics. Politics that are dangerous to public health. It's indefensible.

Dr. Tom Frieden
@DrTomFrieden

Two unexplained, inexplicable, probably indefensible changes, likely imposed on CDC's website. * Dammit, if you come from a place with lots of Covid, quarantine for 14 days * If you're a contact, get tested. If +, we can trace your contacts and stop chains of spread. A sad day.

 

[vtac]

Commentary on the first documented case of reinfection and immune memory.

 

[macbill]

FDA gives go-ahead to fast $5 coronavirus test that doesn't require lab equipment

The Food and Drug Administration has authorized emergency use of a coronavirus test that costs $5 and can produce results in 15 minutes without the use of any lab equipment.

The company says it plans to ship “tens of millions” of the tests to customers beginning in September, and is on track to manufacture 50 million tests a month from October on.

 

[Tranquility]

They're gathering info to see if a civil rights investigation regarding the alleged funneling of Covid patients to nursing homes is needed.
Department of Justice Requesting Data From Governors of States that Issued COVID-19 Orders that May Have Resulted in Deaths of Elderly Nursing Home Residents


Here's more on how rapid testing might solve everything. Once it is invented. And, once all the pesky regulations forced on us by the experts are...well, should they be overcome by compliance or by fiat?
‘Instant Coffee’ COVID-19 Tests Could Be the Answer to Reopening the U.S.

Edit:
Oops, I posted before reading. It looks like "fiat" it is. Orangemanbad or orangemangood?

(To be fair, the test approved by the FDA linked by @macbill is NOT the spit-test needed according to the Instant Coffee theory. As the article said, " Health care providers still must administer the test but it can be done in point-of-care settings like offices. ")

Edit, edit:

https://www.nytimes.com/2020/08/26/world/covid-19-coronavirus.html#link-75471d37

Same shit, different day. As with so many other things, this president can't keep his short little fingers off our federal response to the virus. He interferes with medical authorities same as he interferes with women. "When you are a star they let you get away with it." Now he is fucking with all of us. Damn right I'm angry! You don't have to be a genius to understand what they are doing here: lowering the official number of new cases by testing less in an attempt to aid the president's re-election. "So I told my people: slow the testing down!" Scum! Murderers.

Only one of the candidates is credibly accused of sticking fingers where they are unwanted and that's Biden. (See Tara Reade) Sure, you can bring up other things, but to your specific allegation you just needed to put out there because orangmanbad, in reality, puts Sniffy Joe into the dock.

As to the testing, how does testing help in the situation described? What is the purpose? I've posted resources that shouldn't be offensive to the most politically minded whatever, but find your own. Generalized testing does not serve any purpose at a certain point. We've been at that point of wide community spread for a while. For much the same reasons the Obama administration and Sleepy Joe stopped testing in the pandemic they let infect 60 million Americans, the Trump administration (through it's experts) does not think there is a need either. If you have a reason WHY it's a wrong decision, I'd love to hear it.

 

[macbill]

Maine sleep-away camps prevented coronavirus spread among more than 1,000 people, CDC report finds

As school and public health officials look for ways to reopen classrooms safely throughout the country, a potential road map emerges from the experience of four sleep-away camps and the extensive measures they adopted to prevent spread of the novel coronavirus among more than 1,000 campers and staff members.

 

[florduh]

Department of Justice Requesting Data From Governors of States that Issued COVID-19 Orders that May Have Resulted in Deaths of Elderly Nursing Home Residents

I support investigations into America's many COVID failures. I do wonder if the Feds are going to have a hard time going after Governors when Federal guidelines for nursing homes issued 3/13 read in part: "Nursing homes should admit any individuals that they would normally admit to their facility, including individuals from hospitals where a case of COVID-19 was/is present."

Generalized testing does not serve any purpose at a certain point.

That's silly. If someone was exposed to COVID but is currently asymptomatic, of course you'd want them to get a test before they just go out there possibly spreading it around. Asymptomatic patients are still 75% as contagious as more severe cases. That's one reason why the new CDC guidance is stupid.

Americans, the Trump administration (through it's experts) does not think there is a need either. If you have a reason WHY it's a wrong decision, I'd love to hear it.

I already provided the most obvious one. It's also possible this has way more to do with the Trump Administration's political wishes than any expert.
Experts Alarmed as CDC Abruptly Changes COVID-19 Advice Amid Reports of Interference

After previously encouraging people without COVID-19 symptoms to get tested if they have been exposed to someone diagnosed with the virus, US health authorities have abruptly reversed their position without a clear explanation.

The changes in guidance were quietly made to the Centers for Disease Control and Prevention (CDC) website on Monday amid US media reports of political interference from the White House.

President Donald Trump has repeatedly said that the US should do less testing, and blamed testing for making it appear as though the country is doing poorly against the pandemic.

This is not true: though the US is testing at a high level, that is because its outbreak is worse than any other country in the world, with more than 5.8 million confirmed cases and almost 180,000 deaths.