CORONA Main Coronavirus thread

Heliobas Disciple

TB Fanatic
(fair use applies)

Doctor blunders
Sometimes preprints and press releases save lives; sometimes they are propaganda; You have to use your brain. That's a big ask these days.
Vinay Prasad
15 hr ago

Reading and interpreting medical evidence is its own competency. Being a doctor is surprisingly poor preparation. The vast majority of physicians aren't trained in reading and interpreting medical evidence, and, unfortunately, are not good.

Being a reductionist scientist is suboptimal. You may forget that a mannequin in a chamber is insufficient to infer population level efficacy in the messy real world. You forget the emergent and unanticipated effects that arise as you move from theory to reality.

Two people can both be good at reading papers, but still not see eye to eye because of different priors. Yet, good readers often agree on the limits of evidence. Wrong denominator. Selection bias. Residual confounding. Etc. Good readers often have a mental encyclopedia of similar situations in biomedicine. I consider people like Adam Cifu, Walid Gelad, Venk Murthy, John Mandrola and others to be good readers. Even when we disagree, we agree.

There are many e.g. of poor medical interpretation during COVID-19. MMWR published a steady stream of flawed work. One IFR meta-analysis forced a single point estimate despite sky-high heterogeneity. The authors didn't understand that there was no single IFR, but it varied by setting, and thus forcing a point estimate is a fools’ errand. It was ironic that they simultaneously cast stones at others, while making rookie mistakes.

But in my mind one of the biggest early pandemic errors, which would serve as prelude for many more, was the interpretation of the RECOVERY study.

Remember back to those early days. Doctors panicked and were giving patients random drugs with no credible evidence. Hydroxychloroquine was part of a Harvard hospitals protocol. It wasn’t just Trump’s delusion, let’s not forget.

Anticoagulants were given to thousands at Mt Sinai— in a shameful uncontrolled study. It was the Wild West.

The first light in the darkness was the large RCT RECOVERY. It found dexamethasone improved outcomes for hospitalized patients on O2. Interaction coefficients were significant & the results were parsimonious. It worked as O2 demand rose, and as one was later in the course of illness. The UK investigators held a press conference to disseminate the results.

Many lives could be saved if we listened.

A new article in Nature Medicine describes these events, and is worth reading. It makes this point
Natalie E. Dean, PhD @nataliexdean​
.@PeterHorby on how rapid communication saved lives.​
Why preprints are good for patients

The moment I saw the RECOVERY result, I remembered that I had heard of the trial before. The statistical plan was online, as was the protocol. I read both. Everything was clean and pre-specified.

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But doctors online, including some luminaries, started to say we should wait to treat until we read the full paper.

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But that point of view was just plain stupid. First, those retractions occurred DESPITE a full paper (actually 3!). Proving that waiting for a paper was not a 100% guarantee.

But more importantly: here you had a cheap drug, impartial investigators, and a statistical analysis plan and protocol online. Yes, a paper is great (it’s like a passport), but a press release and SAP and protocol is also great (it like a drivers license, credit card and SS card to boot!) Meanwhile, what we were doing was Wild West medicine based on nothing. Of course we should switch right away. I tweeted as much at the time.


And even had an explainer on when press releases were credible and when they were not.

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But, many doctors not good at appraising evidence piled on.

Of course, they were wrong.

The truth is this has been the root problem with COVID policy.

The same people not good at interpreting RECOVERY are not good at interpreting data for masking toddlers or school kids; not good at interpreting data on vaccines/ myocarditis/ VITT; Not good at reading or interpreting data on kids vaccine/ booster vaccine effectiveness. And terrible at thinking about Long COVID and school closure.

They create pockets on twitter where they are united by Political Ideology and Virtue Signaling and boost each other.

They use hostility to hide their incompetence. This is an ancient practice in medicine, to be fair, and is the reason why some attendings snap at students who ask probing questions that might reveal their own incompetence.

RECOVERY was an early sign that much of #medtwitter would be incapable of handing the issues to come, and that surely came to pass.

It turns out there is a price to not teaching doctors how to interpret evidence, and spending more time focusing on rewarding people to signal virtue than think virtuously. That price is catastrophically bad policy decisions. Sad to watch, worse to experience.

Wanted to update my piece with this walk down memory lane. RECOVERY was a great moment where people who did not know anything about clinical medicine were discounting the results. The error would carry forward.

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Zoner

Veteran Member
Is this a joke you heard or are you being serious? They're really going to call it omega, as in Alpha (first variant) - Omega (last variant)? Someone is making fun of us (the regular folk in the world (vs the deep state)) if this is true...

HD
I heard it suggested but it can’t be since O was already used with omicron.
 

psychgirl

Has No Life - Lives on TB
There is another Geert interview, a lot of the same ground covered, some different ground covered because of the questions asked. It sounds like this was recorded around the same time but before his interview with Del Bigtree was posted based on some of the discussion toward the end.

RightonPoint
58 min 54 sec
May 13 2022
Geert Vanden Bossche discusses natural immunity and why vaccine immunity will be very problematic for so many. Wayne Rohde, host of Right on Point is joined with Ben Smith
Bumping, to watch this one later.
 

Tristan

Has No Life - Lives on TB
This video is not available on youtube so I can't embed it. You can find it on Rumble at this link:


THE VANDEN BOSSCHE WARNING
The HighWire with Del Bigtree
1 hr 55 min
Published May 6, 2022

Acclaimed vaccinologist, Geert Vanden Bossche, sits down for his second groundbreaking interview with Del to explain why the intense pressure mass vaccination is putting on the Covid-19 virus will likely drive it to become catastrophically deadly.



Well, Geert has had some deep insight in the past, during this science-enabled epic disaster.

If he's spot-on in this case, we have perhaps a few weeks to months before new, deadlier super-varientS (perhaps multiples) begin circulating around the globe.

The info was dense and I'm going to invest in another viewing...

One note from the interview: Geert projects that without mass chemo-prophylaxis (safe antivirals such as Ivermectin, maybe Paxlovid are mentioned...) the vaccinated will drive variants till disastrous variants escape - and the vaccinated will bear the brunt of the damage (my paraphrase - hope I got it right)

As we know, prophylaxis has been actively blocked by tptb.

At this point I'm praying Geert is wrong.
 
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Tristan

Has No Life - Lives on TB
There are very few Covid related articles today. It's very quiet out there, even the medical pages have no new articles. I'm not sure what to make of it. I'm not cutting back on the articles I'm posting, there just aren't any articles to post....





(fair use applies)

White House Asks For Another $20 Billion In COVID Money To Stop Winter Wave
by Tyler Durden
Monday, May 09, 2022 - 09:00 AM

Here we go again.

Just when the world (or rather, the US) was finally coming around to the notion that the COVID pandemic might be over, the White House has offered the latest reminder that this is simply not the case. As COVID cases surge in the US, White House COVID response coordinator Ashish Jha said Sunday morning that the Biden Administration will need to authorize another $20 billion+ in COVID spending to pay for the next round of shots needed to stop another brutal winter wave later this year.

Specifically, Jha called on Congress to approve $22.5 billion, a number that will help the federal government replenish its dwindling vaccine supply. If it doesn't the US "is going to run out of treatments...we're going to run out of testing."

Fortunately, at-home tests are available at most pharmacies in the US these days.

If Congress does not approve the White House’s request for an additional $22.5 billion in COVID emergency aid, Dr. Ashish Jha warns that U.S. is "going to run out of treatments, we’re going to run out of testing.” ABC News – Breaking News, Latest News, Headlines & Videos pic.twitter.com/fm75VyjPtP
— This Week (@ThisWeekABC) May 8, 2022

This would imply that the FDA will approve a fourth shot for all Americans (not just the eligible elderly) by the time the winter rolls around, as the general population's immunity begins to wane.

With enough resources to get more people vaccinated and more therapeutics in place, he said, "I do think we can get through this winter without a lot of suffering and death."

Jha cited the Northeastern US, a region with among the highest vaccination rates, as an example of how vaccines can lower the rate of hospitalizations and deaths.

US COVID deaths in the US are slated to pass 1 million as soon as this week (although as we have explained, it's unclear how many of these deaths were actually caused by COVID, as opposed to another co-occurring illness. It's worth noting that the CDC recently revised its figures for COVID deaths among children).


Maybe they're experiencing that moment when they realize things just ain't like they thought...
 

psychgirl

Has No Life - Lives on TB
Well, Geert has had some deep insight in the past, during this science-enabled epic disaster.

If he's spot-on in this case, we have perhaps a few weeks to months before new, deadlier super-varientS (perhaps multiples) begin circulating around the globe.

The info was dense and I'm going to invest in another viewing...

One note from the interview: Geert projects that without mass chemo-prophylaxis (safe antivirals such as Ivermectin, Paxlovid are mentioned) the vaccinated will drive variants till disastrous variants escape - and the vaccinated will bear the brunt of the damage (my paraphrase - hope I got it right)

As we know, prophylaxis has been actively blocked by tptb.

At this point I'm praying Geert is wrong.
You’re correct on all points. I’ve watched two videos, the long one gets tedious but wow! Is that man knowledgeable!

He has a third I’m going to watch when I can.
 

Tristan

Has No Life - Lives on TB
(fair use applies)

NIH Director Says Error Was Made When Chinese Sequencing Data Was Pulled Offline
By Zachary Stieber
May 12, 2022

The National Institutes of Health (NIH) made an error when it took COVID-19 sequencing data offline, the agency’s head said on May 11.

“In the way it was originally eliminated from public view, it was ‘withdrawn.’ And that’s the most difficult for people to access. The error that was made—and we found this out after a review of all of our processes—is, it should have been ‘suppressed,'” Dr. Lawrence Tabak, the acting NIH director, told members of Congress during a hearing in Washington.

Sequences that are withdrawn are kept, but only on a tape drive. In contrast, information that is suppressed can still be accessed by its identifying number, “and so researchers are still able to access that information,” Tabak said.

The doctor did not share more details about the error and the NIH did not respond to a request for comment.

The sequencing data was submitted to the Sequence Read Archive, a database managed by the NIH, in early 2020. The data showed sequences of the CCP (Chinese Communist Party) virus. Also known as SARS-CoV-2, the virus causes COVID-19.

About three months after it was posted, the same researcher who submitted the data asked for it to be “retracted,” according to emails obtained by a nonprofit called Empower Oversight. The NIH agreed to take the information offline.

The action was first disclosed by Jesse Bloom, an American researcher, in June 2021.

The agency “has no plans to change the policy that recognizes submitters rights to their own data and the right to petition that their data be withdrawn,” an NIH spokesperson said in a previous statement in response to Bloom’s paper.

Both Bloom and Dr. Francis Collins, the NIH’s director until late 2021, described what happened as the deletion of data. The NIH has since contested that description.

On Wednesday, Tabak was questioned by Rep. Jaime Herrera Beutler (R-Wash.) as he appeared before the House Appropriations Committee.

Beutler said she’d been tracking reports of the deletions since 2021 and asserted there were “rational concerns that the Chinese Communist Party had something to do” with the sequencing being taken offline and asked what the NIH was doing to secure the archive from such efforts.

“There’s no question that the communication that we had about the sequence archive could have been improved. I freely admit that,” Tabak said. “If I may, the archive never deleted the sequence. It just did not make it available for interrogation. We have the information.”

“Anybody who submits to the Sequence Read Archive is allowed to ask for it to be removed, and that investigator did do that. But we never erase it,” he said.

When the information was withdrawn, it could not be accessed by researchers or other members of the public. When it was changed to a suppressed status at a later time, researchers who knew its identifying number could view it.

Empower Oversight President Jason Foster told The Epoch Times that the way the data was handled effectively deleted it.
“NIH documents released with Empower Oversight’s report demonstrate that the sequencing data was deleted from public view by the NIH at the request of the Wuhan researcher,” he said.

In giving out the emails to the nonprofit and other organizations, the NIH redacted the name of the Chinese researcher who submitted and requested the retraction. Internal emails suggest it was Ming Wang, who works at the Hospital of Wuhan University and later included some of the data in a paper published by Small.

Chinese officials said that the retraction was requested because the researchers found it “unnecessary” to keep their data in the NIH database when it was being published elsewhere.

The emails show Bloom gave top NIH officials, including Collins and Tabak, notice of his forthcoming paper, with Collins calling what Bloom did “clever sleuthing” that discovered sequences “that were deposited (and then deleted)” from the archive.

After Bloom sent the version of his paper to a preprint website, a conference call was held on the subject that included Dr. Anthony Fauci, Collins, Tabak, and Bloom, among others. Bloom alleged that Dr. Kristian Anderson, a critic of the theory that the virus came from a Chinese lab, said he was a screener at the website and could delete the submitted paper or revise it, according to notes from the call (pdf). Andersen told Vanity Fair the allegations were false.

The Epoch Times has submitted Freedom of Information Act requests for information pertaining to the call and for the review of the archive processes.

Mark Tapscott contributed to this report.


Error, or effort?
 

Tristan

Has No Life - Lives on TB
(fair use applies)

China Tightens Restrictions On Overseas Travel While Shanghai Aims For 'Zero COVID' By Mid-May
by Tyler Durden
Friday, May 13, 2022 - 11:15 AM

In what was interpreted as good news by traders, Shanghai is finally looking to unwind certain lockdown measures, while simultaneously tightening the city's restrictions on "non-essential" overseas travel for its citizens to help contain the worst coronavirus outbreak the country has seen in the past two years.

China has said it will impose tight restrictions on "non-essential" overseas travel for its citizens to help contain the worst coronavirus outbreak the country has seen.

Shanghai Vice Mayor said the city is aiming to stamp out all community spread of the virus by mid-May and is considering expanding the scale of production resumption, while they will aim to open up, ease traffic restrictions and open shops in an orderly manner, according to the SCMP.

A statement on the agency's website said the meeting had been called to relay the decisions taken at a meeting of the Politburo Standing Committee chaired by President Xi Jinping on May 5, where the leadership doubled down on China's zero-COVID policy saying it "will stand the test of time".

The city, meanwhile, is expected to prioritize resuming classes for grades 9, 11 and 12, while supermarkets, convenience and department stores will resume offline operations in an orderly manner and other services such as hairdressing will open gradually.

Shanghai is to prioritize the resumption of classes for grades 9, 11 and 12, while supermarkets, convenience and department stores will resume operating offline.

The immigration authorities on Thursday said the curbs were designed to stop infections crossing the border and would include a more rigorous approval process for passports and other travel documents and a crackdown on illegal border crossings.

A meeting of the National Immigration Administration on Tuesday heard that China's COVID situation had reached a "significant and urgent point" and that the city of Beijing was the "most important of the important" places.


Wait, isn't restricting travel supposed to be Racist?
 

Tristan

Has No Life - Lives on TB
Thank you for this head's up. It sounds like it could be Covid. They aren't vaccinated in NK so if it is covid, this is not/can not be the variant Geert is worrying about. It's just them being exposed to a very contagious Omicron without having any natural antibodies and probably an immunocompromised population so more vulnerable in general.

But because it's NK, you have to wonder.... is this a lab leak of some other pathogen that NK was working on in its own biologocial WMD labs? Or is it a testing of a new variant of Covid on the NK population by China or another country? You never know when it's NK. I hope to post some articles about NK later when I post the news articles.

HD


I would not trust any data coming out of North Korea.
 

Heliobas Disciple

TB Fanatic
... At this point I'm praying Geert is wrong.

So am I.

I've watched 4 video interviews he gave in the last few days, most of them more than once. I think I have his theory down now. I wonder though if he could be right about overcoming the infectiousness immunity pressure but that the virus won't be as driven to overcome the virulence pressure. After all, the virus evolutionarily wants to spread to as many hosts as possible, which vaccinating into the pandemic allowed it to do, as we see daily. But maybe the drive to become more virulent isn't baked into its evolution. Maybe, hopefully, ?, he's wrong about that second prong. I think that could be why other experts we've been relying on (Malone, et al) are giving his theory credence but not saying it's a certainty. Bottom line - Geert's theory that this is going to mutate into a highly dangerous strain rests on the virus overcoming the immune pressure to become more virulent - what if there isn't that pressure? What if the only pressure is to spread to as many hosts as possible? that's my hope, but he's the expert, I'm the armchair covid watcher. I'd bet on him before I'd bet on me...

HD

HD
 

Heliobas Disciple

TB Fanatic
In Del's summation, he says "these Scientists have no clue what they're doing to us..."

I think he should give some consideration to the antithesis of that assertion.

I notice they are reallly careful to attribute what's going on to incompetence instead of malfeasance. Probably safer that way, and a good way to insure that the message they are delivering isn't dismissed as 'woo' / conspiracy. But I wonder what they're really thinking in private...

Maybe they're experiencing that moment when they realize things just ain't like they thought...

I thought of that too when I noticed it got quiet out there. I'm starting to find more articles again, but not as many. Hard to report the vaccines don't work which if they want to keep reporting, they're going to have to admit.


Error, or effort?

Exactly!


I would not trust any data coming out of North Korea.

I kind of do. It's not good news, it's news Kim would hide if he could so that makes me believe it more. Are the numbers totally accurate? I don't know. But I do believe he has a major outbreak going on.

That being said, there's so much to be learned from the NK experience right now. Kim has a nation that has been locked down and not exposed to any other variants (unless he kept that secret and only now is revealing an outbreak, which makes no sense). And no one vaccinated. This is a perfect 'laboratory' to test herd immunity. It makes me wonder if this is deliberate - as Geert says, those who get Omicron now who aren't vaccinated are (the equivalent of) getting a live attenuated vaccine. Maybe the NK medical community came to that conclusion on their own, and decided to (equivalent of) "mass vax" its population with the weak Omicron variant and have them build up herd immunity. There are over 1 million cases, and less than 100 deaths. This isn't killing his population but it is giving them immunity. The MSM in the USA continually underestimates Kim to their detriment, he already has nukes, hypersonic missiles, submarine missiles and a space program. While our future scientists are pretending they are the opposite gender and going to Antifa rallies, his are in school studying real science.

HD
 
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Heliobas Disciple

TB Fanatic
Speaking of NK.

(fair use applies)

North Korea Claims over 1 Million Coronavirus Cases in Less than a Month
By Frances Martel
16 May 2022

The government of North Korea announced that it had documented 1,213,550 cases of “fever” in the country, referring to Chinese coronavirus, between “late April” and Monday, an astonishing number given that the communist regime had claimed not to identify a single case of the disease before last week.

The state-run newspaper Rodong Sinmun claimed that 50 people had died in North Korea from Chinese coronavirus so far.
“According to the information of the state emergency epidemic prevention headquarters, over 392,920 new persons with fever, some 152,600 recoveries and 8 deaths were reported from 18:00 of May 14 to 18:00 of May 15 throughout the country,” Rodong Sinmun reported. “As of 18:00 of May 15 since late April, the total number of persons with fever is over 1,213,550, of which more than 648,630 have recovered and at least 564,860 are under medical treatment. The death toll stands at 50.”

The government of dictator Kim Jong-un announced on May 12 that a “break” had occurred in the country’s attempts to keep the disease out of the country and that, for the first time since scientists identified the Chinese coronavirus as a novel pathogen in late 2019, Pyongyang had identified confirmed coronavirus cases. Many international observers loudly questioned the communist Workers’ Party of Korea (WPK) claims that it had kept the disease entirely out of its borders for two year, particularly given rumors circulating in dissident media of infectious disease and a bizarre speech a crying Kim Jong-un issued in October 2020 apologizing for a particularly difficult year for his citizens.

Rodong Sinmun reported that Kim has held at least two high-level WPK meetings since last Thursday to personally oversee the situation, one on Saturday and one on Monday. During the more recent meeting, Kim appeared to scold his officials for failing to provide sufficient access to necessary medication or organize the health response to the reported outbreak properly.

“The Political Bureau of the Party Central Committee issued an emergency order to immediately release and timely supply the state reserve medicines to swiftly contain and control the spread of the epidemic and an order for all pharmacies to switch over to the 24-hour operation system,” the state newspaper observed, “but the orders have not yet been carried out properly and medicines have not been properly supplied to pharmacies.”

“Pointing out that the medicines provided by the state have not been supplied to inhabitants through pharmacies correctly in time,” it continued, “he [Kim Jong-un] said it is because officials of the Cabinet and public health sector in charge of the supply have not rolled up their sleeves, not properly recognizing the present crisis but only talking about the spirit of devotedly serving the people.”

“He [Kim] strongly criticized the Cabinet and public health sector for their irresponsible work attitude and organizing and executing ability,” according to Rodong Sinmun. “Saying that most of pharmacies have not been arranged so as to successfully fulfill their function and they are in such a poor situation as they don’t have medicine store houses except showcases, he referred to the situation in which salespersons offer service without proper white gowns and hygienic environment does not reach the standard.”

The government newspaper seemed to nonetheless blame the documented coronavirus deaths on popular ignorance in a separate article, claiming that some North Koreans had been “careless” in medicating themselves properly.

“As regards the fact that those, careless in taking drugs due to the lack of knowledge and understanding of stealth Omicron variant virus infection disease and its correct treatment method, assumes a large proportion of the dead,”
Rodong Sinmun alleged, “since the outbreak of the present anti-epidemic crisis, various undertakings are being conducted urgently to remedy it.”

In announcing the outbreak last week, the North Korean government, through its popular media arms, called it “a most serious emergency case of the state” and claimed that Kim had ordered a lockdown on “the entire country.”

“Emergency measures are being taken to block all provinces, cities and counties across the country, isolate working units, production units and living unions,” Rodong Sinmun reiterated on Saturday, “make a more strict concentrated medical checkup of all inhabitants to find out all persons with fever and abnormal symptoms and thoroughly isolate them and actively treat them.”

North Korea’s communist regime claimed to have documented zero coronavirus cases before the vague timeline of “late April” prior to last Thursday. It had reported only one “inconclusive” test to the World Health Organization (W.H.O.) in August 2020. North Korea shares borders with China, the origin nation of the Chinese coronavirus, and two of the countries most severely affected by the pandemic, Russia and South Korea, leaving many unconvinced that it had successfully kept the virus out.

The announcement of a “total” lockdown last week makes North Korea one of the few countries left in the world still implementing mass house arrest to attempt to keep case numbers low. Other than the Pyongyang regime, China is the only major country on the world stage to adhere to the policy, continuing to keep 26 million residents of Shanghai, its largest city, locked down as of press time. The Shanghai lockdown has devastated China’s economy and triggered significant civil unrest and global condemnation.

Reports from witnesses inside North Korea suggest that the current large-scale coronavirus outbreak was partially triggered by a giant military parade last month to celebrate the nation’s armed forces. A North Korean border security official stationed near China told Radio Free Asia (RFA) last week that guards near the Yalu River border between the two countries had begun showing coronavirus symptoms in early May.

“Most of the ones who tested positive are officers and soldiers who took part in the military parade … on April 25,” the anonymous guard claimed. “The health authorities reported the incident to the national emergency quarantine command, who in turn sent it in as a No. 1 [top importance] report.”

Another guard told RFA that the regime had ordered soldiers to wear gas masks to prevent the disease from spreading.
The South Korean newspaper JoongAng Ilbo reported on Monday that sources familiar with Pyongyang-Beijing relations have evidence that North Korea reached out to China for help procuring basic supplies like coronavirus testing kits.

“According to the sources, the items specifically requested by North Korea include polymerase chain reaction (PCR) test kits and medicines to treat [Chinese coronavirus],” JoongAng Ilbo reported. “Talks on the delivery methods and amount of equipment are currently underway between the two countries, the sources said.”

Chinese officials had previously expressed openness to helping North Korea with supplies if needed.

South Korean President Yoon Suk-yeol also offered a helping hand on Monday.

“We must not hold back on providing necessary assistance to the North Korean people, who are exposed to the threat of the coronavirus,” Yoon said on Monday, speaking to the National Assembly for the first time since his inauguration on May 10. “If the North Korean authorities accept, we will not spare any necessary support, such as medicine, including [Chinese coronavirus] vaccines, medical equipment and health care personnel.”

North Korean officials have repotedly not responded to the offer at press time.
 

Heliobas Disciple

TB Fanatic
(fair use applies

Spread of Epidemic and Result of Treatment Informed

Pyongyang, May 17 (KCNA) -- According to the information of the state emergency epidemic prevention headquarters, over 269 510 persons with fever, some 170 460 recoveries and 6 deaths were reported from 18:00 of May 15 to 18:00 of May 16 throughout the country.

As of 18:00 of May 16 since late April, the total number of persons with fever is over 1 483 060, of which more than 819 090 have recovered and at least 663 910 are under medical treatment.
The death toll stands at 56. -0-

www.kcna.kp (Juche111.5.17.)
 

Heliobas Disciple

TB Fanatic
(fair use applies)



KPA Surgeons Launch Campaign for Supplying Medicines to Pyongyangites

Pyongyang, May 17 (KCNA) -- On the special orders of the Party Central Committee expecting the Korean People's Army to play the role of the main force in defending the country's safety and people's lives in the present public health crisis, a powerful force of the military medical field was immediately dispatched for the supply of medicines vital to the ongoing anti-epidemic campaign.

Surgeons met at the Ministry of National Defence on Monday to vow to discharge their honorable mission in the struggle for defusing the public health crisis prevailing over the capital city of Pyongyang.

Attending the meeting were those of the military medical field of the Korean People's Army who were to be involved in the supply and transport of medicines in Pyongyang City and officials of the Ministry of National Defence.

Pak Jong Chon, member of the Presidium of the Political Bureau and secretary of the Central Committee of the Workers' Party of Korea, conveyed the special order of the WPK Central Military Commission on urgently dispatching the military medical force of the KPA to the anti-epidemic front of the capital city.

Speeches were made by Colonel General Kwon Thae Yong, first vice-minister of National Defence and director of the KPA General Logistics Department, officer Ryang Chung Sok and non-commissioned officer Choe Tong Ju.

Recollecting the love for the people of General Secretary Kim Jong Un who took an important measure unprecedented in the history of the army-building while guiding in the van the anti-epidemic campaign since the grave situation caused by the inroad of COVID-19 into the country, the speakers expressed their determination to devotedly safeguard the security of the capital city as fortresses and bulletproof walls.

They said they would devote themselves to the transport and supply of medicines with the political awareness that the supply of medicines is not a mere practical work for medical treatment, but a noble patriotic work for conveying the warm sincerity of the respected Comrade Kim Jong Un to the people.

They also expressed their will to convey the precious medicines, elixir of life, associated with the great love of Kim Jong Un for the people to the Pyongyangites, regarding the posts in their charge as frontline trenches as befits those dispatched by the Party Central Committee.

They ardently called for dynamically defusing the public health crisis created in Pyongyang and becoming honorable victors by working heart and soul so that the revolutionary surgeons in the great era of Kim Jong Un can review with pride how they devotedly implement the combat order of the Party in the war against the malignant virus.

A letter of pledge to Kim Jong Un was adopted at the meeting.

The letter reflected the resolution of loyalty of all the participants in the meeting to surely emerge victorious in the anti-epidemic campaign by successfully implementing the special order of the WPK Central Military Commission.

At the end of the meeting, certificates of dispatch in the name of the KPA committee of the WPK were awarded to the officers and non-commissioned officers who were to be urgently dispatched as members of the group for treatment and medicine supply to defuse the public health crisis in Pyongyang City.

The officers and non-commissioned officers were warmly seen off by officials of the Ministry of National Defence, service personnel and their families.

They started the supply of medicines immediately after arriving on the spots with the enthusiasm to faster and more correctly convey the warm love of the mother Party to the citizens. -0-

www.kcna.kp (Juche111.5.17.)
 

Heliobas Disciple

TB Fanatic
(fair use applies)

Former Biden COVID advisor warns long-term virus modeling 'based on pixie dust'
Osterholm said the White House may have predicted massive COVID case numbers in order to secure more pandemic relief funding
By Madeline Hubbard
Updated: May 16, 2022 - 11:35pm

Former Biden COVID task force member Michael Osterholm warned that the public is experiencing "whiplash" with pandemic regulations and any long-term modeling of the virus is "based on pixie dust."

CNN's Peter Bergin asked Osterholm last week about a "big disconnect" between the White House, which predicted up to 100 million COVID cases this fall, and the Centers for Disease Control and Prevention, which is now only recommending masks to be worn on public transportation.

"I think this has been kind of a whiplash moment for the public on Covid-19," Osterholm replied.

Osterholm, the Center for Infectious Disease Research and Policy director at the University of Minnesota, said he has not seen data supporting the possibility of a 100 million case surge this fall.

"No one should make that kind of statement without providing the assumptions behind that number. Could it happen? Sure, but it's more likely if a new variant shows up that is more infectious and more likely to evade existing immune protection than Omicron," Osterholm noted.

"Any modeling that looks beyond 30 days out is largely based on pixie dust," he explained. "I worry that the White House has gotten way ahead of their skis on this one, but I understand the administration is trying to emphasize the need for Covid relief money."
 

Heliobas Disciple

TB Fanatic
(fair use applies)

Shanghai says it will begin lifting COVID-19 lockdown that started over six weeks ago
Shanghai officials expected the lockdown that started March 27 to last only until April 5
By Just the News staff
Updated: May 16, 2022 - 8:41am

Shanghai on Monday announced plans to start as of June 1 a process to end its roughly six-week COVID-19 lockdown in the major Chinese city and economic hub.

Deputy Mayor Zong Ming said Shanghai will reopen in stages and residents' movements will largely remain in place until May 21 to prevent another surge in infections, according to Reuters.

She also said officials would fully restore normal production and life in the city – "as long as risks of a rebound in infections are controlled" – from June 1 to mid- and late June.

However, residents remain skeptical, considering officials have previously changed such schedules for lifting restrictions.

China, where the virus was first detected in late 2019, has over roughly the past two month locked down dozen of cities, impacting hundreds of millions of consumers and workers and hurting its economy – as most other countries have lifted most restriction.

China has the world's second-largest economy after the United States', and its lockdown has resulted supply chains and international trade problems around the globe..

Shanghai officials expected the lockdown that started March 27 to last only until April 5.
 

Heliobas Disciple

TB Fanatic
(fair use applies)

Congress and the Pandemic Response: An Interview with Thomas Massie
By Brownstone Institute
May 16, 2022

Congressman Thomas Massie of Kentucky is the rare example of a statesman in the US who saw the pandemic and response with scientific clarity from the very beginning. He was never shy about sharing his views both in speeches and on social media, even when it contradicted the priorities of his own political party.

He spoke out that “two weeks to flatten the curve” made absolutely no sense. He was also personally responsible for forcing a quorum back to Washington, D.C., only one week into lockdowns, thus earning wild attacks from all sides.

He has been consistent from the beginning to end, sticking to good science and principle but always with charm and intelligence. As a result, he is hugely popular within his district, simply because voters know that he will always tell the truth as he sees it. In that way, he should serve as a model and inspiration for others.

In this interview, Congressman Massie shares the inside story of those absolutely critical first weeks of lockdowns, providing a deep and penetrating look into why he believed what he did and what fallout that brought down on him during a national hysteria.

He further reveals details not reported before such as the role of the White House in lobbying for the disastrous CARES Act (“the we don’t care act”) from March 2020 that set the stage for economic collapse and the current crisis.

The Brownstone Institute is deeply grateful for his time and the compliments he gives to our work. First the video and then the transcript follows.

Congress and the Pandemic Response: An Interview with Thomas Massie
43 min 38 sec



Jeffrey Tucker:

Hi, this is Jeffrey Tucker at the Brownstone Institute, and I’m thrilled to be here with my friend Thomas Massie, Congressman from Kentucky. Thanks for taking the time to be with us.
Thomas Massie:
Hey, thanks for what you’re doing at the Brownstone Institute. And thanks for having me on to set the record straight.
Jeffrey Tucker:
Well, this is what we need to do. I’m very worried about this because I’m getting concerned that we’re not going to tell this history of what happened properly. There’s a few things that I kind of want to get codified for the record about your involvement from the very early days. So if we could go back to March, 2020, and if you could explain to me what your intuitions were initially when we heard the slogans flatten the curve.
Thomas Massie:
Yes, we were going to flatten the curve, right? We were told that we would take just 15 days to slow the spread. On about the fourth day to slow the spread, I woke up early in the morning and did some math. I did some calculations. By the way, I went to MIT, did undergraduate and graduate degrees there in engineering. So I’ve had a little bit of math. I understand differential equations, but it wasn’t even necessary to bust out the differential equations to figure out that 15 days was not going to slow the spread. I calculated, if this strategy was going to have any effect, it would have to last for months and months, that it would go at least through the summer, if it was going to have any effect at all. I waited for my wife to wake up. She also went to MIT. So I got her to check my homework as she did when we were at MIT. She said, “I think you’re right.”
Jeffrey Tucker:
You did this based on the existing case reporting and what was presumed to be the R-naught at the time, the infection rate.
Thomas Massie:
Yes, that’s correct. At the time we had information from cruise ships, for instance, which are kind of like little test tubes or Petri dishes to look at, okay, if you assume complete exposure, how many are going to get it? How many will come down? How many will it be fatal with? So I made some quick estimates and some assumptions. My assumptions were probably too rosy even. Later that week or that day, I broke it to my staff. I told them, I said, I’ve done some math. This is not 15 days. So on Easter, our governors sent out state troopers to take down the license plates of people who defied him to go to church. Also, there was a woman who tested positive for COVID in Kentucky, and they wanted her to sign a document to say that she wouldn’t leave the state.
She wouldn’t leave her house. She agreed not to leave her house, but she refused to sign a document. She thought, well, what if I have to go … if there’s an emergency, life or death situation. They sent police to her house and put an ankle bracelet on her in Kentucky to track her. So all of these horrific things we saw on the news happening in China were happening in the United States. Meanwhile, Jeffrey, and again, let me get us back to about the fourth day of 15 to slow the spread. We’re being told we’re going to vote on a giant spending package. The numbers were changing. We weren’t sure what the numbers would be, how much would the money be. I was waiting, I was on call. I was ready to come to DC and debate that and vote on that.
Meanwhile, they were making preparations for continuity of government. Now, this is where things are going to sound conspiratorial, but I can point you back to articles that show what was happening in the event that the branches of government quit functioning. There’s sort of a military government that would take over in this country to maintain law and order. They were making preparations for that. They were telling people, if you remember also, not to leave your state. There was a discussion whether to shut down all the New England states, whether basically to stop all traffic in and out of New York state. There were discussions, serious discussions about that. You can go back in the news and find these things.
Jeffrey Tucker:
So March 12th, flights from Europe blocked, or at least stopped, and so everybody had to come back by Monday or Tuesday causing massive overcrowding. The Fauci, Birx, and Trump press conference occurs on Monday the 16th, at which Fauci clarified, everything has to shut down, bars, restaurants, all public events. If there’s evidence of community spread, he said. Birx is saying a new rule: Everybody has to stay separate from everybody else. That was on Monday. So by Friday, you’re saying there’s already talk of a gigantic spending bill.
Thomas Massie:
Yes, gigantic, unprecedented. So I’m sitting there at home. Actually, I believe it was a Wednesday or Tuesday evening. I think it was a Tuesday evening. I saw Trump’s people come on TV. Larry Kudlow was one of them. He said, well, it’s not really a $2 trillion bill you’re underselling. It’s a $6 trillion bill. We’re going to give $400 billion to the Federal Reserve. They can loan that out at a 10-to-one ratio and inject another $4 trillion of liquidity into the economy. It’ll be really $6 trillion. When I realized that the Republicans were bragging that this was $6 trillion, not really $2 trillion, don’t undersell it, I thought we are in trouble.
Thomas Massie:
Then shortly thereafter, I get an email from House leadership that says, stay home. We don’t need anybody here, and we’re going to pass this. By the way, we still didn’t have the wording of it. We’re going to pass the bill with nobody in Congress. Now this concerns me on many different levels. Number one, if the branches of government quit functioning, that gives an excuse for the folks who are up there, circling in airplanes, ready to roll out the plan for continuity of government that doesn’t include the legislative branch or even the existing people in the executive branch.
Jeffrey Tucker:
Yeah. Well, that’s what they wanted. I mean, clearly that’s the way they’ve behaved for two years, by the way.
Thomas Massie:
Yes. So it bothered me in that part. It also bothered me that this was the biggest spending bill in history. Even the omnibus bill was half that size. So the omnibus bill, which sets records every year, is typically like a trillion dollars or $1.1 trillion. And this was going to be over $2 trillion. If you listen to Larry Kudlow, it was a $6 trillion bill. The final thing that bothered me the most is it’s just flat out unconstitutional to pass a bill with nobody there. The Constitution says that you have to have a quorum to do business. In other words, to pass bills that are going to have any legal effect.
Jeffrey Tucker:
Meanwhile, you’ve got public health authorities saying quorums are just going to be super-spreader events. So we can’t have them essentially.
Thomas Massie:
Right. Although, by the way, there was a way for Congress to vote one at a time. We could have gone into the chamber one at a time and voted. There’s no requirement that you all be in the room at the same time, unless you’re trying to pass a bill without a quorum and somebody notes the absence of one. By the way, this was a technical detail I argued with Nancy Pelosi on for about 15 minutes, that it would be safer for us to vote on the bill than to have a quorum call, but we’ll get to that point in chronologically three days from what I’m speaking about now.
So at 11:00 PM that evening, I resolved to go to DC and tell them you’re going to have to vote on this. By midnight, I had my bags packed. I got in my car. It typically takes about eight hours to get to DC for me, but I hadn’t slept. So I slept for one hour at a truck stop. By the way, I stopped at three places to buy gasoline in West Virginia and they were all closed. There are the signs erected on the interstate, get off the interstate, trucks only, stay home. If you could remember, the whole world was in a panic at this time, and people were ready to take advantage of it.
Jeffrey Tucker:
Yeah. Everybody’s forgotten this. I’m so glad you’re telling this. Those were terrifying weeks.
Thomas Massie:
The third exit I took off the interstate, I found a gas station where you could buy gas with a credit card. It was unattended. It was like the zombie apocalypse or something. So I filled up my tank with gas. I slept for an hour at a truck stop after that, and then I made it to DC by 9:00 AM. You can go back and look in the record on tweets, in my tweets. This is sort of documented. They knew I was there. So, they were accusing me of trying to delay the vote, but they had fiddle farted around for about a week. The Senate had passed this and the Senate showed up to pass it, by the way.
Two senators were not there who might have objected. Due to COVID, they weren’t there. Rand Paul and Mike Lee were not in attendance because one of them had had COVID and one of them had been exposed to COVID. So that’s another reason why I ended up bearing the brunt of this. So I showed up that morning, and this is documented in social media history, in my tweets. There’s these breadcrumbs in the records you can go back and look at if anybody doubts this. I told people, for instance, tweeted out that the Constitution requires a quorum. I was trying to sort of acclimate my colleagues, in fact, that they were going to have to show up and vote. I did something I almost never do. I told our own whip team what my plans were. The whip team says, don’t surprise us. Just tell us what you’re going to do.
We just don’t want to be surprised. Well, then they take that information and they weaponize it against you. I knew they were going to weaponize it against me. They did. They ginnedit up by Thursday when I, in no uncertain terms, told them we were all going to come and vote because I was going to require it. By the way, the parliamentarian who’s ecumenical, he’s neither Republican nor Democrat. He’d been there for four or five Speakers of the House. He agreed with me. He told them Massie’s right. His interpretation of the Constitution is spot on. The Constitution says the House can make its own rules, but those rules can’t violate the Constitution. The Constitution requires a quorum. So they knew I was right. They were going to have to come and vote. They ginned up the entire media against me.
Even Fox was demonizing me. You can go back and hear Geraldo Rivera saying how bad I was and how this was such a bad thing for me to do. Meanwhile, they did find some things about the bill they didn’t like. They found $25 million for the Kennedy Center for the Arts. As if that was the problem with the bill, that it wasted a little bit of money here or there. Not that it was going to bankrupt our country or that it was going to basically put all the governors in a moral hazard where they had to shut down their own economies.
Jeffrey Tucker:
Right. Maybe we want to go there because I don’t think this critique is widely understood. In other words, every time I make it, people are shocked by the point. I got the point from you. I had never thought about it. Your point is that … it was called the Cares Act. Am I right?
Thomas Massie:
Yes. I called it the Don’t Cares Act.
Jeffrey Tucker:
Yeah. But your argument from the very beginning was that this would operate as a kind of a subsidy for the lockdowns. It would perpetuate lockdowns.
Thomas Massie:
Yes.
Jeffrey Tucker:
Can you explain how that works?
Thomas Massie:
Until a year later there weren’t really any federal lockdowns or mandates or things like that. It was all being promulgated by the governors, but it was done, number one, with the imprimatur of Dr. Fauci and Dr. Birx. They were skirting around, skipping around to all the state health departments and giving the imprimatur of the federal government to do these things. In fact, if the governors had gone the other way after hearing the advice from the federal government, it would’ve opened them up to a lot of lawsuits, because here you had the CDC and the NIH and the top scientists in the federal government advising one thing. So you had the imprimatur of the federal health policy experts that worked for Trump at the time. They had too much slack to go do this. Then meanwhile, you had the funding from the federal government.
One of the arguments my Constitutional conservative colleagues were making, that I was a little bit sympathetic to at first, was that this is a taking, and the Fifth Amendment requires us to compensate people for takings. Here’s the problem. The takings hadn’t happened yet. We were bribing governors to do the takings. By the way, if the state does the taking, it’s not the federal government’s obligation to do the paying back.
Jeffrey Tucker:
Right.
Thomas Massie:
Ultimately, the only thing I thought that would bring the governors to their senses is when they shut down their own economies, they would not have tax revenue, and they can’t print money, and they would be shutting down their own governments.
Jeffrey Tucker:
Right. But then suddenly, after the Cares Act passes, of course there’s tremendous pressure now already from the bottom to give us money, give us money. We want this money. Then after it started arriving, there was no reason to open up. Suddenly, the federal government became benevolent and generous.
Thomas Massie:
Yes.
Jeffrey Tucker:
In a way we had never seen before in our lifetimes.
Thomas Massie:
Right. You had things like minimum basic income. If you look at some of these policies, it was like we’re just going to give you money. By the way, it was a $2 trillion bill, but I said the $1,200 checks were the cheese and the trap. People saw $1,200, but if you multiplied … and I thought I would get some sympathy from the Democrats for this. If you looked at how much money was going out and compared it to the $1,200 checks that were going to go out, it was like 10 to one. The money was going somewhere else. It wasn’t going to individuals, but nobody was doing the math on that. By the way, Jeffrey, just to close out this point, Ron DeSantis, who in my opinion is the best governor, bar none, in the United States, even he shut down Florida for a little while as soon as the Cares Act passed.
He was also put in the same situation, but he did something brilliant. He banned Dr. Fauci and Dr. Birx from coming to Florida and talking to any state employee. That was a stroke of brilliance. So you’re not going to spread the imprimatur, the federal government, and establish that baseline here in Florida. You’re banned. He banned them.
Jeffrey Tucker:
Yeah. So he was suspicious from the beginning about this, but it took him a long time to finally … that sounds like he opened up Florida entirely until about August, right? Or may have been sooner than that, July.
Thomas Massie:
Yeah. I don’t remember the exact timeline, but again, I want to give him a lot of credit because he was at the forefront of this. But what I’m saying is the federal government really put all the governors in a bind by sending out this money. That was my problem with it is the policies were bad. You were going to pay people not to work. By the way, I pointed out at the time for about a month, I went on a road trip of shows, trying to explain to people all the bad things that were going to emanate from this. For instance, I own a farm and I’m connected to a lot of farmers in Kentucky. I realize if you don’t plant fruit trees that summer, it takes three years for a peach tree to bear fruit and five years for an apple tree to bear fruit.
If those people who normally plant those trees aren’t planting them, the tail on these shortages and price increases is at least five years long. I took some of my cattle to a processor that processes beef cattle, and I saw healthy dairy cattle being processed into hamburgers because, at the time, because of the shutdowns, we had dairy that couldn’t go into the market. Farmers were feeding dairy cattle, milking them, and pouring the milk out because it was normally packaged to go to schools and to go to restaurants, and it wasn’t packaged for selling in restaurants. They didn’t even have enough equipment to package it, to sell it in restaurants.
So they then just pour out the milk. You can only do that for so long. Eventually, they were butchering dairy cattle. It takes three years from the time you decide you want a milk cow to create a cow that can milk. The mother has to gestate. It has to be born. It has to reach breeding age. It has to be bred itself. Then it gets its milk when it has its first calf. That’s a 3-year process. Those were the things I was trying to explain at the time that we were touching off by telling everybody to stay home and not go anywhere.

[continued next post]
 

Heliobas Disciple

TB Fanatic
[continued]

Jeffrey Tucker:
That’s just one sector. You’ve got tens of millions of them, you’ve got the chip issue abroad. God knows what happened to baby formula. So these supply chain issues were utterly wrecked by these closures, not just domestically, but internationally.
Thomas Massie:
Absolutely wrecked, and still we’re feeling the long chain of this, the bolus. I don’t even know that we’re at the peak or the tail end of it yet because they sort of compound. These issues compound. Anyways, this was my great fear. By the way, it was a living nightmare for me to see this three years, five years into the future, the kids who are going to miss two years of education and socialization and whatnot. By the way, there was, at the time … this is another bit of irony. This CDC was telling everybody, including Congress, not to wear masks. Just to go back and look at the video of me there in Congress, demanding the roll call vote in the quorum and to see that nobody had a mask on.
Jeffrey Tucker:
Yeah, that’s right. Yeah, I remember that was briefly … That was also the time when the virus was considered to be inside. No, it was considered to be outside, so we had to be inside, and then later the virus moved.
Thomas Massie:
Yeah, and it was droplets. By the way, Nancy Pelosi later created a Plexiglas box in Congress. After accusing me of putting everybody in Congress at risk of losing their lives, come January 3rd of the next year, she created a Plexiglas box with no top in the gallery of Congress, right below the air conditioning vent, where the air is being blown into the House of Representatives for people with COVID to come and vote for her to be speaker.
Okay. So back to the date of … it was, I believe, the 10th day of 15 to slow the spread where I made the motion. It went from Wednesday to Thursday. Again, they’re fiddling around. They came up with this plan. Instead of passing it by unanimous consent, they were able to placate some of my colleagues by offering instead a voice vote instead of unanimous consent, which are virtually the same. In effect, they are the same. The only difference being they would debate the bill. They would spend four hours debating the bill. If you wanted, you could register … instead of voting against the bill, you could register your objection during the debate.
By the way, each side had two hours. The time was equally divided and everybody was here in Washington, DC because I was quoting the Constitution and it required them to show up. I went to the man managing the time on our side, the Congressman. I said, “When can I have a minute or couple minutes or a minute, or 30 seconds even to debate this bill?” He said, “Oh, we didn’t know you wanted to speak on this issue. So you’re not in the queue. We don’t have time for you to debate it.”
Can you imagine that? They all hate me for breathing air because I compelled their attendance on the biggest spending bill in history. They claim that they wouldn’t even yield me 30 seconds because they didn’t know I was interested in discussing the merits or demerits of this bill.
Jeffrey Tucker:
How was the vote finally taken? Was it just a voice vote?
Thomas Massie:
So this is interesting. I had to decide at what point I was going to exhaust all of my avenues of protest. I was on the floor watching the floor. By the way, I was whipped. But if people don’t understand what whipping means, the name is appropriate. When you first hear, oh, they whip members of Congress to get them to do something. You think something bad, and then you find out, oh, it’s just trying to get them to vote a certain way. But then once you understand what the whip process involves, I don’t want to say it’s waterboarding, but it’s an exercise in psychological warfare.
They get your friends to call you. They call you in the middle of the night. They call you in the morning. I was sleep deprived. I had people calling me at midnight. I had people offering me better committee assignments. I received a phone call from the president. At the instant I was supposed to make the motion, it would be in order to make the motion, I got three phone calls from the White House. I presumed, I knew who that was, but I couldn’t leave the floor because there’s a moment where things are in order. And if you miss that 3-second window, it’s gone for all of history. Nobody would even cover that moment if I went to the bathroom. I had to sit there for hours to make sure they didn’t do a sneak, the quarterback sneak.
So I get these calls and I couldn’t take them. Obviously I was busy, occupied, but eventually stepped out when they yielded some time to somebody. I realized there would be a few minutes where they couldn’t sneak the bill through. I walked out into the speaker’s lobby and I called the president back. That was a fun phone call. By the way, I’m not going to go into all the details of it because he has graciously, two years later, he’s now endorsed me this week.
Jeffrey Tucker:
Well, anybody who’s curious can look up the public record about the names you were called and who said what to whom. So I think that’s out there and I encourage everybody to do so. Strange times, because all this happened under a Republican House, Senate.
Thomas Massie:
It was a Democrat House, but a Republican president, but the Republican minority leader was one of the people who was whipping me to vote. Not just to vote for it, but just not to object.
Ultimately, you have to decide what your battle is. As I approached that day, I decided that my battle was just to try and get a recorded vote. So I requested a recorded vote and something that has never happened in the eight years that I had been in Congress, and something that’s never happened since that day, they denied my recorded vote. I had earlier, a few years before, asked the parliamentarian, “What would transpire if you were denied a recorded vote? How would they arbitrate that?” Because you have to count … The Constitution says if 20% of Congress wants a vote, you have to give the vote. I said, “Well, how would you count that? How would you physically … what would be the process for that?” He said, “Mr. Massie, it’s so messy. We’ve never denied anybody a recorded vote, and we likely never would.” Well on this day, they did.
I’m not saying that 20% of Congress did stand. In fact, 20% of Congress did not stand. They were all in their seats. Maybe there were five or 10 out of 435 who stood. Then something else that’s unprecedented in the history, since the beginning of Congress, happened that day. They counted people present who were only in the gallery. Typically, you have to be on the floor to participate, but they recognize people in the gallery as being present. Long story short, they denied the recorded vote. I made note that a quorum was not present. They said a quorum was present. At that point, there may have been other parliamentary avenues for me to pursue. But at that point, I let them own their mistake. At that point I had done everything I could do. By the way, when I stood up, they didn’t give me even 30 seconds or five minutes to debate this bill.
So I did something that is not in order. Instead of just making a motion that a quorum is not present, I got about 20 seconds of speech out before they ruled me out of order. Then I made my order. I said, “Madam Speaker, I’m here today to make sure that our Republic does not die by unanimous consent in an empty chamber. And I object on the basis that a quorum is not present.” I saw them about to gavel me down, but at least I got one sentence into that debate and injected it while I was making my motion.
Jeffrey Tucker:
Absolutely beautiful. Can I ask a slightly naive question? I don’t understand. Nobody understands how this stuff works, but March 12th, we got the shutdown time. HHS on March 13th releases a document that says, oh, if community spread gets bad, we’re going to shut everything down. But Trump has not given the order yet. March 16th, he goes out to the press conference, having been persuaded over the course of the weekend. Oh, now we should shut down. Ten days after that you’ve got a bill. How big?
Thomas Massie:
It was enormous, but I didn’t print it out. I don’t even know that there was time to print it out, but it was, I think, $2.2 trillion in hard dollars. They said $6trillion in spending authority, basically.
Jeffrey Tucker:
Here’s the question I have. Who wrote this? If somebody had to … where does this stuff come from? If all the politicians are panicked at home, worried about COVID, and the government shut down, what are these bills? Is there some machine out there that cranks them?
Thomas Massie:
It was written in part by the White House. The White House had a lot of input into it. In fact, I was told … By the way, one of my best friends is Mark Meadows. You can believe they employed him to whip me. He was chief of staff at the White House at the time. By the way, I have to say, I love Mark Meadows dearly. The two of us architected the coup that took out John Boehner.
So we’ve been in the trenches together and he didn’t really try to whip me that hard, but I told him, I said, “Mark, this is the biggest spending bill I’ve ever seen. It’s way too much money.” He said, “Well, it is. It’s more money than we need. The reason it’s so big is so we don’t have to come back and pass another one.”
He probably thought that at the time. I didn’t believe it. Later we came back and spent another $4 trillion after that first $2 trillion. So he was not correct in his assessment, but he had input into it. I’m telling you that the White House had input into it just based on my discussions with chief of staff Meadows. There were people from Wall Street that had input on it. This is where I would’ve expected AOC and Bernie Sanders to speak up, because this was the biggest transfer of wealth from the middle class to the upper class in the history of humankind. The Roman emperors couldn’t pull this off.
Jeffrey Tucker:
Do you believe that all this happened between the 16th and the 24th? Do you really believe that a bill this size with this level of specificity was hatched in those 10 days?
Thomas Massie:
I don’t know. I can’t go too deep into that, but I can tell you, I think one of the reasons they were so upset with the prospect that I might delay the bill is that some transactions had already occurred and that it would be illegal. What they had done would be illegal if they didn’t quickly also pass the bill to consummate the transfers that were happening. Because you see, this is March 27th. It’s a Friday. Then there’s a weekend, and the quarter ends on March 31st. It was so irrational that they would get so upset, or maybe somebody stood to collect interest on $2 trillion over the weekend. What would be the interest on $2 trillion in somebody’s bank? But it doesn’t make sense. Maybe someday somebody can go back and exhume the artifacts of the transactions and the wire transfers and what actually happened.
Jeffrey Tucker:
There’s a lot of strange things. I even think about this HHS, March 13th document, which is apparently secret. I don’t know if you even saw it at the time, but the New York Times reported on it about a month later. They already had a blueprint out before Trump had been persuaded.
Thomas Massie:
I don’t know if we’re going to get … I want to make sure we don’t forget about this when we’re laying down what’s happened here, because this is one of the most important things. If you go look at the Fed’s balance sheet in March, they did a couple things. One, the balance sheet tripled overnight, somewhere in that period. They say part of that’s due to the redefined certain terms. On the money supply, they show the money supply also went up enormously, and they said, well, that’s because we changed.
Jeffrey Tucker:
I think that was in May. Am I right about that?
Thomas Massie:
Yeah. Well, you may be right, but here’s the main point.
Jeffrey Tucker:
The balance sheet anyway. It was already expanding before the bill was passed.
Thomas Massie:
Yeah. I don’t know when the definition changed, but here’s what happened. There wasn’t $6 trillion to borrow over the last two years. There’s borrowing authority, but then there’s also, who’s going to loan you that money. Up until that point, we had accumulated $24 trillion of debt, primarily by borrowing from other countries, by borrowing from corporations, by selling treasuries to individuals who wanted a safe investment. So we had accumulated $24 trillion, but when you go out to borrow another $2 trillion, it’s not sitting around. People don’t have it to loan to you. So what happened and what has happened again, and is happening over the last two years, is the Federal Reserve created roughly $6 trillion out of thin air.
Jeffrey Tucker:
Right, according to M2 anyway. Right.
Thomas Massie:
Yeah, and according to their balance sheet. They had a fairly large balance sheet with some bad debt and stuff they had accumulated, but nothing compared to the $5 or $6 trillion that they’ve added to it. I’ve got a debt clock here in my office and, in the last two years, it’s jumped from $24 trillion to $30 trillion. But the alarming thing, or maybe it’s comforting to you, we didn’t really borrow $6 trillion. The Federal Reserve created it and then we borrowed it from the Federal Reserve. The Federal Reserve, their balance sheet includes more Treasury securities than anybody else holds. Not Japan, not China. Nobody holds as much Treasury securities as the Federal Reserve right now. It was a shell game. The reason I know I’m chronologically a little bit out of order, because I’m talking also about the next $4 trillion that was spent, but it started on March 27th.
They didn’t find $2 trillion on March 27th to borrow. This is why you have inflation and why it’s not going away. It’s baked in. There’s 30% inflation baked into everything now. That was one of my concerns at the time. I articulated it. Go back in the annals of Twitter and you will find that I am saying this will create inflation and it will create shortages. So some people say, well, what did you accomplish? You didn’t even force the recorded vote. Well, I think I proved that government could still operate, that we didn’t need some contingency government to kick in. I protected the Constitution that day. But also look at what happened after that.
On March 28th, or the next Monday, the White House announced, you know what? We’re not going to shut down New York and other New England states. We’ve decided to leave them open. So it’s sort of like, by compelling all of those members of Congress to engage in interstate travel, I showed that it was still possible. Now some of those members of Congress, there were four members of Congress looking at each other on an empty plane. But because we kept things going, they had to acknowledge you could still travel. So that, I feel like, is one of the things that was accomplished.
Jeffrey Tucker:
It’s hard for people to remember these days. In fact, maybe you sense this too, I see an active campaign to forget, to pretend as if this never happened. Even Fauci yesterday in testimony said “We never locked down. There weren’t really any lockdowns.”
Thomas Massie:
By the way, I just remembered the name General Terrence J. O’Shaughnessy. You can put that in a search engine and a Newsweek article. Also, he showed up on Fox. That was going to be your leader of the contingency government. They were introducing him to people that week. Go look at it. It’s in the record. They can’t memory haul it.
Jeffrey Tucker:
Okay. Okay. Well, there is so much more we could talk about. I think we should maybe I hope do that someday, but I think we should stop here because I know you’re busy and we have covered this early section really, really well. I just think it’s extremely important we know this history because, as I say, I’m sensing there’s an effort to bury all this, pretend like it never happened.
Thomas Massie:
Yeah. There was a phone call with members of Congress and Dr. Fauci, just to sort of close this out. I remember two of the questions that were asked, one by me and one by Representative McClintock from California. Representative McClintock from California asked, and this was around about that time. It may have been April or May, but McClintock asked, “Dr. Fauci, in these policies, have you taken into account the side effects of shutting down the government on the health of people? For instance, poverty is one of the leading indicators of shorter lifespans, and this is going to create some level of poverty. We’re going to impoverish people by shutting down our economy. Have you taken that into account?” Dr. Fauci said, “I’m just singly focused on this one virus and that’s what I’m working on.”
Thomas Massie:
That was a wake-up call to me, very dangerous. The question that I asked was, “I know you can’t tell us the date at which you think everything should be opened up, because there’s so many issues, but what are the criteria that we need to meet in order for you to recommend opening our country back up?” He had no criteria because they really had no criteria other than panic for shutting it down. That’s when I knew we were in for a long haul and we were in for a lot of trouble as long as Dr. Fauci was in charge.
Jeffrey Tucker:
You figured it was going to last till November.
Thomas Massie:
At least until November. Oh, Jeffrey, let me tell you one more thing. It’s so important. So important. Congress and my Republican colleagues in particular were arguing that it was too dangerous to vote in person in March. Then they turned around and, by November, all 50 states implemented methods and procedures for our constituents to vote remotely. For the first time we had a remote election, but Congress was setting the prototype for it on March 27th. This was a chess move.
Jeffrey Tucker:
Amazing, amazing.
Thomas Massie:
I’ll be honest, on March 27th I didn’t recognize it, but very quickly within a couple weeks, I realized they were setting the precedent for remote voting in all 50 states by arguing, if it’s too dangerous for members of Congress who have paid government healthcare, security guards, very good ventilation wherever they meet, if it’s too dangerous for them to show up and vote, how could you then later argue that American people have to show up and vote? So anybody who’s upset about election fraud or how the elections were carried out, or these drop boxes or the mailing in, your Republican members of Congress were arguing that it was too dangerous for them to vote. Then they set the precedent for everybody else to vote remotely.
Jeffrey Tucker:
It’s weirdly ingenious, or maybe it’s accidentally brilliant, or God knows. I don’t know. Well anyway, thank you Congressman for helping us. You’re guiding us through these early days, which are so important. I’m very happy that you’re able to set that record straight. I hope we visit again very soon.
Thomas Massie:
Thank you for documenting this for history. I hope you etched this into a gold CD rom and can put it in a copper container that can’t be corroded and save it in a time capsule, because the winners write history, right?
Jeffrey Tucker:
That’s right.
Thomas Massie:
They’re going to try and rewrite history. They already are. They’re changing definitions. They’re setting up a ministry of truth. They’re doing all this so that they can establish history. God bless you for trying to establish the real history with the facts of what happened.
Jeffrey Tucker:
We’ve just begun. Thank you, Congressman.
Thomas Massie:
Thank you.
 

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Higher COVID-19 Infection Rates Among Vaccinated Children Than Unvaccinated, CDC Data Show
By Harry Lee
May 16, 2022

According to data released by the Centers for Disease Control and Prevention (CDC), higher COVID-19 case rates have been recorded among fully vaccinated children than unvaccinated in the age group 5-11 since February.

On Feb. 12, CDC reported a weekly case rate of 250.02 per 10,000 population in fully vaccinated children aged 5-11, compared to 245.82 for unvaccinated children in the same age group.

That’s the first time CDC recorded a higher case rate among fully vaccinated young children since data was first collected in December 2021. It remains for the following weeks till the third week of March, the latest week with available data.

Epoch Times Photo

COVID-19 case rates between fully vaccinated and unvaccinated children aged 5-11. (CDC/Screenshot via The Epoch Times)
Epoch Times Photo

Data about COVID-19 cases between vaccinated and unvaccinated children aged 5-11. “Crude vax/unvax IR” means the unadjusted incidence rate of the corresponding outcome among the population vaccinated/unvaccinated (per 100,000 population). “Crude IRR” means unadjusted incidence rate ratio (unvaccinated : vaccinated). (Data from CDC. Highlights made by The Epoch Times)

Children aged 5–11 years became eligible for COVID-19 vaccination on Nov. 2, 2021. There are about 28 million children in this age group in the nation.

Currently, about 28.8 percent of children in this age group have been fully vaccinated, according to Mayo Clinic.
CDC’s data also show the gap in rates of cases between fully vaccinated and unvaccinated has become increasingly smaller among other age groups. The death rates show the same trend between fully vaccinated and unvaccinated for people above 50. For people under 50 years old, the death rates have not much difference since the rollout of the vaccine.

Epoch Times Photo

Rates of COVID-19 cases by vaccination status, booster dose, and age group. (CDC/Screenshot via The Epoch Times)

Epoch Times Photo

Rates of COVID-19 deaths by vaccination status and age group. (CDC/Screenshot via The Epoch Times)

The data show that the COVID-19 vaccines have a “negligible effect” on people, said Dr. Peter McCullough, a renowned cardiologist and epidemiologist.

“With these results in hand, it is clear the vaccines are having a negligible effect in populations,” McCullough told The Epoch Times via email. “Given the overall poor safety profile and lack of any assurances on long-term safety, Americans should be cautious in considering additional injections of these products.”

CDC responded that several factors contribute to this phenomenon in the age group 5-11.

“Several factors likely affect crude case rates by vaccination and booster dose status, making interpretation of recent trends difficult,” Jasmine Reed, a CDC spokesperson, told The Epoch Times via email.

“Limitations include higher prevalence of previous infection among the unvaccinated and un-boosted groups; difficulty in accounting for time since vaccination and waning protection; and possible differences in testing practices (such as at-home tests) and prevention behaviors by age and vaccination status. These limitations appear to have less impact on the death rates presented here.”

Reed also directed The Epoch Times to a study published by CDC in March, showing Pfizer’s vaccine reduced the Omicron infection among children and adolescents aged 5-15.

Pfizer’s vaccine is the only COVID-19 vaccine that can be administered to the age group 5-17. Pfizer hasn’t responded to a request for comment.

“CDC is assessing whether to continue using these case rate data to provide preliminary information on vaccine impact,” Reed added.

On May 13, a study published by the Journal of the American Medical Association found that Pfizer’s COVID-19 vaccine turned negatively effective after five months.

The protection also waned considerably against hospitalization over time, the study found. The authors said one way to combat the negative effectiveness was to get a booster dose.

McCullough said most non-randomized studies attempting to estimate vaccine efficacy (VE) had some “common flaws”, including no accounting for baseline prior COVID-19 infection; no reporting for currently boostered within a 6-month time window; and no adjudication of hospitalization or death due to COVID-19 or other conditions.

“As a result, most studies of COVID-19 VE have biases towards overestimating any clinical benefit of vaccination,” said McCullough.

The Food and Drug Administration (FDA) is expected to authorize a booster shot of the Pfizer vaccine for children 5-11 as early as Tuesday, The New York Times reported.

Last month, Moderna requested an emergency use authorization for its COVID-19 vaccine for children 6 months to 6 years of age. As the FDA postponed its decision in February on whether to authorize its COVID-19 vaccine for children six months to four years old, Pfizer is now working on data for a three-dose regimen.

Zachary Stieber contributed to this report.
 

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Pfizer’s COVID Vaccine Protection Against Omicron Fades After a Few Weeks: Study
By Jack Phillips
May 16, 2022

The protection afforded against the Omicron coronavirus variant fades quickly after a second and third dose of Pfizer–BioNtech’s COVID-19 vaccine, according to a peer-reviewed study published in the JAMA Network.

A Danish study published in the JAMA Network on May 13 found that there was a rapid decline in Omicron-specific serum neutralizing antibodies only a few weeks after the administration of the second and third doses of the vaccine.

The study evaluated 128 adults who were vaccinated, and of that number, 73 people received two doses of the Pfizer vaccine, and 55 people received three doses between January 2021 and October 2021 or were previously infected before February 2021, and then vaccinated.

“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses,” an abstract of the study reads. “The observed decrease in population neutralizing antibody titers corresponds to the decrease in vaccine efficacy against polymerase chain reaction–confirmed Omicron infection in Denmark and symptomatic Omicron infection in the United Kingdom.”

The antibody levels, which are associated with protection against future infections, dropped within a few weeks of getting the vaccine doses. They were also much lower than the antibodies specific to the Delta and original COVID-19 strains, according to the study.

The proportion of Omicron-specific antibodies fell to 53 percent between the eighth and tenth week from 76 percent four weeks after the second dose. At weeks 12 to 14, these levels dropped even more to only 19 percent, according to the study.

Those antibodies increased with a third dose, increasing 21-fold three weeks after the dose before dropping to eightfold at week four. But with the third dose, antibody levels dropped as early as three weeks, falling 5.4-fold between the third and eighth week, the researchers said.

They concluded that it may be needed to provide additional booster doses to combat the Omicron variant, which emerged last fall, primarily among older individuals.

However, a study from Israeli researchers published in early April in the New England Journal of Medicine found that a fourth dose, or a second booster, of the Pfizer vaccine, doesn’t offer strong protection.

“Overall, these analyses provided evidence for the effectiveness of a fourth vaccine dose against severe illness caused by the omicron variant, as compared with a third dose administered more than 4 months earlier,” the study’s authors wrote at the time, after analyzing data from the Israeli Ministry of Health. “For confirmed infection, a fourth dose appeared to provide only short-term protection and a modest absolute benefit.”
 

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View: https://www.youtube.com/watch?v=pcWxX68y19E
Disaster in North Korea
20 min 49 sec
May 16, 2022
Dr. John Campbell

North Korea, tragic situation, UK and US slowly stabilising. https://www.theguardian.com/world/202... https://www.telegraph.co.uk/world-new... UK, alpha wave, patients admitted to hospital UK, alpha wave, deaths Omicron started to spread, late April End of two-year coronavirus blockade, maintained at great economic cost Omicron in Pyongyang Factors Long term malnutrition Current malnutrition Untreated long-term diseases Poor housing Limited supply of medicines, steroids, antibiotics Zero vaccination Little previous infection Naïve population Omicron, not delta (Official Korean Central News Agency) Kim Jong Un Covid outbreak is a great disaster for North Korea causing great upheaval Announced 51 new fever deaths First case confirmed Thursday Had activated maximum emergency quarantine system Nationwide lockdowns Up to May 13 1,213,550 cases of fever More than 524,440 fallen sick with fever at least 81,430 were fully recovered Official Korean Central News Agency Over half a million currently receiving medical treatment The spread of malignant disease comes to be a great upheaval in our country since the founding of the DPRK Army to distribute medicines on immediately stabilising the supply of medicines in Pyongyang because officials of the Cabinet and public health sector in charge of the supply have not rolled up their sleeves, not properly recognizing the present crisis strongly criticised the Cabinet and public health sector for their irresponsible work attitude Leif-Eric Easley, professor, Ewha University in Seoul The language he's used suggests the situation in North Korea is going to get worse before it gets better Engagers see this rhetoric preparing the way for international assistance, but Kim may be rallying a population on the verge of further sacrifice Kim Jong Un, meeting on anti-virus strategies in Pyongyang Kim, front and centre (39) minimising the losses in human lives Country will actively learn from China's pandemic management strategy not an uncontrollable spread among regions but transmission within areas that had been locked down Previously turned down offers of Covid vaccines from China and Covax scheme Beijing and Seoul issued fresh offers of aid and vaccines Health and healthcare in North Korea: a retrospective study among defectors (Conflict and Health) https://conflictandhealth.biomedcentr... Public Health Act, comprehensive free care system Widespread informal expenditure Lack of medicines Extensive self-medication with narcotic analgesics Party membership Respondents who could not enjoy political and economic rights were substantially more likely to report illness, and extremely reduced access to care, even with life-threatening conditions. Maxar Technologies New excavation at the Yongbyon facility in North Korea, (plutonium)
 

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Trained Sniffer Dogs Accurately Detect Airport Passengers With COVID-19
By BMJ
May 16, 2022


Likely to be especially valuable in the early stages of any pandemic, suggest researchers.

Trained sniffer dogs can accurately detect airport passengers infected with SARS-CoV-2, the virus responsible for COVID-19, finds research published today (May 16, 2022) in the open access journal BMJ Global Health.

According to the researchers, this form of detection is likely to be very important not just in the early phases of a pandemic when other resources may not yet be accessible, but also in helping to contain an ongoing epidemic.

Dogs have an extremely acute sense of smell, and can pick up a scent at levels as low as one part per trillion, far exceeding any available mechanical techniques.

It is thought that they are able to detect distinct volatile organic compounds released during various metabolic processes in the body, including those generated by bacterial, viral, and parasitic infections.

Preliminary data suggest that dogs can be trained within weeks to detect samples from patients with COVID-19 infection, with a degree of accuracy comparable to that of a standard PCR nose and throat swab test.

While promising, these lab data results needed to be replicated in real-life conditions. The researchers, therefore, trained 4 dogs to sniff out SARS-CoV-2 in Spring 2020. Each of the dogs had previously been trained to sniff out illicit drugs or dangerous goods or cancer.

To test the dogs’ detection skills, 420 volunteers provided four skin swab samples each. The 4 dogs each sniffed the skin samples from 114 of the volunteers who had tested positive for SARS-CoV-2 on a PCR swab test and from 306 who had tested negative. The samples were randomly presented to each dog over 7 trial sessions.

Overall, the diagnostic accuracy of all samples sniffed was 92%: combined sensitivity— accuracy of detecting those with the infection—was 92% and combined specificity—accuracy of detecting those without the infection—was 91%.
Only minor variation was seen among the dogs: the best performance reached 93% for sensitivity and 95% for specificity; the worst reached 88% for sensitivity and 90% for specificity.

Some 28 of the positive samples came from people who had had no symptoms. Only one was incorrectly identified as negative and two weren’t sniffed, meaning that 25 of the 28 (just over 89%) were correctly identified as positive: the lack of symptoms didn’t seem to affect the dogs’ performance.

The 4 dogs were then put to work sniffing out 303 incoming passengers at Helsinki-Vantaa International Airport, Finland, between September 2020 and April 2021. Each passenger also took a PCR swab test.

The PCR and sniffer results matched in 296 out of 303 (98%) of the real-life samples. The dogs correctly identified the samples as negative in 296 out of 300 (99%) PCR negative swab tests and identified three PCR positive cases as negative.
After re-evaluation with clinical and serological data, one was judged to be SARS-CoV-2 negative, one SARS-CoV-2 positive, and one a likely post-infectious positive PCR test result.

Similarly, the dogs indicated 4 PCR negative cases as positive. These were all judged to be SARS-CoV-2 negative.
Because the prevalence of SARS-CoV-2 among the airport passengers was relatively low (less than 0.5%), 155 samples from people who had tested positive on a PCR swab test were also presented to the dogs.

The dogs correctly identified just under 99% of them as positive. Had these ‘spike’ samples been included in the real-life study, the dogs’ performance would have reached a sensitivity of 97% and a specificity of 99%.

Based on these results, the researchers then calculated the proportion of true positive results (PPV) and the proportion of true negative results (NPV) in two hypothetical scenarios reflecting a population prevalence of SARS-CoV-2 of 40% and 1%.

For the prevalence of 40%, they estimated a PPV of 88% and an NPV of 94.5%. This means that the information provided by the dog increases the chances of detection to around 90%.

For a population prevalence of 1%, on the other hand, they estimated a PPV of just under 10% and an NPV of just under 100%.

In both scenarios, the high NPV backs the use of sniffer dogs for screening, with the aim of excluding people who don’t need a PCR swab test, say the researchers.

And they suggest that: “dogs could be used both in sites of high SARS-CoV-2 prevalence, such as hospitals (to prescreen patients and personnel), as well as in low prevalence sites, such as airports or ports (to prescreen passengers).” This could save both considerable time and resource, they say.

The researchers acknowledge that dogs trained to sniff out other substances may mistakenly identify these substances as SARS-CoV-2 positive. The required storage period of the training and spiked samples may also have affected the viability of the volatile organic compounds, they say.

A key finding was that the dogs were less successful at correctly identifying the alpha variant as they had been trained to detect the wild type. But this just goes to show how good dogs are at distinguishing between different scents, say the researchers.

“This observation is remarkable as it proves the scent dogs’ robust discriminatory power. The obvious implication is that training samples should cover all epidemiologically relevant variants. Our preliminary observations suggest that dogs primed with one virus type can in a few hours be retrained to detect its variants.”

Reference: “Scent dogs in detection of COVID-19: triple-blinded randomised trial and operational real-life screening in airport setting” 16 May 2022, BMJ Global Health.

DOI: 10.1136/bmjgh-2021-008024

Funding: Evidensia; Swedish Cultural Foundation in Finland; The Finnish Kennel Club; Finnish Cultural Foundation
 

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COVID-19, MIS-C and Kawasaki Disease Share Underlying Molecular Patterns and Immune Response
By University of California, San Diego
May 16, 2022


COVID-19, MIS-C and Kawasaki Disease
UC San Diego researchers summarize the similarities and differences between COVID-19, MIS-C and Kawasaki disease, three conditions unified by the same immune-associated gene signature. Credit: UC San Diego Health Sciences



The inflammatory disorders share similar underlying molecular patterns, a University of California San Diego (UCSD) study reports; findings may improve disease diagnosis and treatment and support new drug targets for MIS-C.


When COVID-19 emerged and doctors raced to define and treat the new disease, they soon discovered it was not the only novel illness caused by SARS-CoV-2. A subset of children infected by the virus also experienced abdominal pain, headaches, rashes, and vomiting. This new set of symptoms was labeled multisystem inflammatory syndrome in children (MIS-C) and had many of its pediatric patients requiring intensive care.

As the prevalence of MIS-C increased, physicians began to note its similarities to a pre-pandemic illness, Kawasaki disease (KD), which has baffled pediatricians for more than 50 years. MIS-C and KD share many symptoms, including fever, rash, and bloodshot eyes, though KD can also lead to coronary artery aneurysms and heart attacks. Unlike MIS-C, which is associated with a specific virus, KD may be triggered by a variety of infectious and environmental stimuli.

To better understand how these inflammatory syndromes compare and contrast, researchers at the University of California San Diego School of Medicine collected blood and tissue samples from MIS-C and KD patients. Using artificial intelligence tools, they analyzed patterns of gene expression in both conditions and compared them to gene expression markers of COVID-19.

The findings, which will be published today (May 16, 2022) in the journal Nature Communications, reveal that MIS-C and KD are on the same immune response continuum as COVID-19, with MIS-C being a more severe version of the response than KD. Despite these underlying similarities, the conditions do diverge in several laboratory and clinical parameters. Authors said the findings could improve disease diagnosis, monitoring, and treatment in pediatric patients.

“We want our immune system to protect us from harmful stimuli, but some children are genetically predisposed to respond more intensely, leading to inflammation and unwanted symptoms across the body,” said co-corresponding author Jane C. Burns, MD, a pediatrician at Rady Children’s Hospital-San Diego and director of the Kawasaki Disease Research Center at UC San Diego School of Medicine. “The sooner we can identify and understand the child’s inflammatory condition, the better we can tailor our delivery of life-saving support.”

The research team previously identified a set of 166 genes expressed in viral respiratory diseases, including COVID-19, a subset of which also corresponded to disease severity. Researchers found that this same “gene signature” also applied to both MIS-C and KD, suggesting the conditions all stem from a similar underlying mechanism, which involves the rapid release of IL15/IL15RA cytokines.

The team then looked at a separate set of 13 genes used to identify KD, and found that a computer program trained to look for this genetic signature could not tell the KD and MIS-C samples apart.

“We were not expecting that,” said co-corresponding author Pradipta Ghosh, MD, professor of medicine and cellular and molecular medicine at UC San Diego School of Medicine. “We analyzed MIS-C and KD through the lens of two distinct gene signatures, and both experiments told us these diseases are closely related.”

Ghosh said the two gene signatures likely represent different parts of the same broader immune response.

While the study provides a new unifying framework for these diseases, it also identifies a few subtle differences. For example, MIS-C patients had lower blood platelet and eosinophil counts, two features that can be measured from routine blood tests. And, while many serum cytokines were similarly elevated in both conditions, a select few were more elevated in MIS-C than in KD samples.

Authors noted that therapeutics targeting some of these cytokines, including TNFa and IL1ß, have already been approved by the U.S. Food and Drug Administration (FDA) and are being tested as novel treatments for MIS-C.

“We believe our findings have a high potential to impact clinical trial planning immediately, and also shape clinical guidelines and patient care down the line,” said co-corresponding author Debashis Sahoo, PhD, associate professor of pediatrics and computer science at UC San Diego School of Medicine and UC San Diego Jacobs School of Engineering.

Reference: 16 May 2022, Nature Communications.

DOI: 10.1038/s41467-022-30357-w

Co-authors include: Gajanan D. Katkar, Chisato Shimizu, Jihoon Kim, Soni Khandelwal, Adriana H. Tremoulet, John T. Kanegaye, Pediatric Emergency Medicine Kawasaki Disease Research Group and Soumita Das, all at UC San Diego, as well as Joseph Bocchini of the Willis-Knighton Health System.

Funding: National Institutes of Health, UCOP-RGPO, iDASH, Patient Outcomes Research Institute, Gordon and Marilyn Macklin Foundation, American Association of Immunologists Intersect Fellowship Program for Computational Scientists and Immunologists, UC San Diego Stem Cell Center
 

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New study finds worrying linked to more COVID-19 preventative behaviors
by Dickinson College
May 16, 2022

People who worried more about COVID-19 also took more precautions against catching the disease, a new study led by a Dickinson College researcher finds. The journal Psychology & Health published the study. Psychology Professor Marie Helweg-Larsen, Ph.D., and her team looked at the interplay between one's perceived risk of getting COVID-19 and the state of worrying about getting COVID-19 and how they influenced behaviors to prevent getting the disease. Researchers found that worrying about COVID-19 better predicted people taking COVID-19 precautions than did their perceived risk—how much at risk people personally thought they were of getting or dying from COVID-19.

"In the context of COVID-19, fear of the disease predicted precautionary behavior over-and-above a range of other variables including perceived risk and even political attitudes," said Helweg-Larsen, who has made international headlines for her research on how people calculate their personal risk. "Worry and thinking you're at risk certainly are related, but they do not play the same role in the precautions people take. Our analysis shows worry, the emotional response, is stronger, which is interesting in a time when we have so much personalized risk information, like the level of COVID in our immediate area," said Helweg-Larsen.

The study examined the responses of 738 people to two surveys, two weeks apart, in April 2020. The surveys asked participants about their worry and perceived risk of catching COVID-19 and what precautions they were taking to keep themselves safe, like social distancing, handwashing and wearing face coverings. The researchers also compared respondents' perceptions of local COVID-19 outbreaks to actual state data on case numbers at the time of the surveys. They found that people who overestimated the number of COVID-19 cases near them were more likely to worry and to then take precautions against the disease.

These findings show the importance of worry as an emotional reaction that leads directly to taking preventative action, something that could be harnessed in public messaging. "It's critical to note that policymakers should not work to create more worry around COVID-19, but they could harness people's worries to encourage them to take more precautions," said Helweg-Larsen.
 

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MY COMMENT: how many of them were vaccinated. No report of vax status in this study.



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COVID-19's high blood clot risk
by University of Oxford
May 16, 2022

1652779663340.jpeg
Cumulative incidence of venous thromboembolism, arterial thromboembolism, and death in COVID-19 cases Data are stratified by age and sex. Estimates (solid lines) are presented with 95% CIs (dashed lines). Index date refers to the date of first COVID-19 diagnosis or positive RT-PCR test result. CPRD Aurum=Clinical Practice Research Datalink Aurum database. IPCI=Integrated Primary Care Information database. IQVIA DA Germany=IQVIA Disease Analyzer Germany database. IQVIA LPD Italy=IQVIA Longitudinal Patient Database Italy. SIDIAP CMBD-AH=Information System for Research in Primary Care Conjunto Mínimo de Datos Básicos al Alta Hospitalaria data. Credit: The Lancet Infectious Diseases (2022). DOI: 10.1016/S1473-3099(22)00223-7

A recent study of patient health records found that around 1 in 100 people with COVID-19 had a venal or arterial thrombosis, with rates higher still among males, and particularly for those hospitalized.

It has been previously estimated that the risk of venal thrombosis (VTE) among people hospitalized with COVID-19 is around 9% while the risk of an or arterial thrombosis (ATE) is 4%. However, little data exists for these events in patients who have not been admitted to hospital.

A new study published in The Lancet Infectious Diseases, estimates the incidence of VTE and ATE among almost 1 million people with COVID-19, using routinely collected data from across Europe. The study found that for people with COVID-19, the risks ranged from 0.2% to 0.8% for VTE. For ATE it was from 0.1% to 0.8%.

Incidence of these events increased to 4.5% and 3.1% for those hospitalized with COVID-19. Meanwhile, 90-day mortality was between 1.1% and 2.0% among COVID-19 cases and increased to 14.6% for those hospitalized.

Results also showed that being male was generally associated with an increased risk of VTE, ATE, and death, as were various comorbidities and prior medications.

Dani Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology at NDORMS said: "While risks are somewhat low overall, given the vast numbers of people who have been infected with SARS-CoV-2, these relatively small risks translate into large numbers of people being affected. The consequences to health, including risk of death, are significant, underlining the importance of effective treatment strategies in the management of severe COVID-19 to reduce their frequency. We need more research into potential strategies to minimize the risk of thrombosis amongst patients with non-hospitalized COVID-19, including possibly vaccines but also blood thinners."

"Our findings highlight the widespread ill-effects associated with COVID-19," commented Ed Burn, senior researcher at the University of Oxford. "The study was over a time period where few people had been fully vaccinated, and one of the many benefits of vaccines against COVID-19 will likely have been reducing the number of such events occurring in the future."
 

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AI models identify COVID-19 patients at the greatest risk of death, injury
by University of Waterloo
May 16, 2022

New artificial intelligence (AI) models can help doctors prioritize care by predicting which COVID-19 patients are most at risk of dying or developing kidney injuries during hospitalization.

The sophisticated computer software, developed by researchers at the University of Waterloo, identifies vulnerable patients by learning from previous COVID-19 patient cases with known clinical outcomes.

"There is tremendous potential for predictive AI models like this as they can greatly aid clinicians in identifying who needs help the most, and most urgently, to increase survival rates and reduce rates of serious injury," said Alexander Wong, a professor of Systems Design Engineering at Waterloo.

The new models are part of an open-source project called COVID-Net that has produced several other innovations since the start of the coronavirus pandemic.

The new AI models work by analyzing clinical and biochemical markers such as serum ferritin levels, use of therapeutic heparin, heart rate and blood pressure, and automatically discovering patterns that are predictive of a patient dying or developing kidney injuries.

Designed using explainable AI technology, the models also explain which indicators they relied on for their predictions, a key requirement to give doctors the confidence to act on the findings.

Explainable AI is a set of tools and frameworks used to help interpret predictions made by machine learning models.

"AI models that provide not just predictions but the rationale behind the predictions can greatly improve trust and widespread adoption to support clinicians in their decision-making processes along the entire clinical workflow," said Wong, a director of the Vision and Image Processing (VIP) Lab at Waterloo. "That's the power of explainable AI."

Researchers collaborated on the models with Dr. Adrian Florea, an emergency medicine physician at CIUSSS de l'Ouest-de-l'Île-de-Montréal, and plan to test them in clinical settings to gain further insights and improve their accuracy.

As with prior research in the COVID-Net project, they have also made their work and results available to researchers and scientists around the world.

"Hospitals are already extremely overburdened by the pandemic, especially with the recent surges due to Omicron and its subvariants and recombinants," said Wong, a Canada Research Chair in Artificial Intelligence and Medical Imaging. "Having AI models to help healthcare workers identify who needs care in an efficient and effective manner can significantly reduce the burden, as well as the costs of healthcare."

Researchers expect the models to be easily transferrable to other diseases and conditions, and they are already exploring their use beyond COVID-19.

Hossein Aboutalebi and Maya Pavlova, both students in the VIP Lab, contributed to the project along with doctoral student Andrew Hryniowski and Mohammad Javad Shafiee, also a systems design engineering professor at Waterloo.
 

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Experimental COVID-19 vaccine provides mutation-resistant T cell protection
in mice

by University of Wisconsin-Madison
May 16, 2022

A second line of defense—the immune system's T cells—may offer protection from COVID-19 even when vaccine-induced antibodies no longer can, according to new research out of the University of Wisconsin School of Veterinary Medicine.

The researchers discovered that a new, protein-based vaccine against the original version of the COVID-19 virus was able to teach mouse T cells how to recognize and kill cells infected with new, mutated versions of the virus. This T cell protection worked even when antibodies lost their ability to recognize and neutralize mutated SARS-CoV-2, the virus that causes COVID-19.

"Antibodies prevent COVID-19 infection, but if new variants escape these antibodies, T cells are there to provide a second line of protection," explains lead scientist Marulasiddappa Suresh, a professor of immunology and associate dean for research at the School of Veterinary Medicine.

The study, published in the Proceedings of the National Academy of Sciences on May 13, investigates the role of T cells, a specialized type of white blood cell, in defending against COVID-19 when antibodies fail.

When you receive a COVID-19 vaccine, your body learns to produce antibodies, proteins in the immune system that bind to and neutralize SARS-CoV-2. These antibodies circulate in the blood stream and protect you from illness by patrolling the nostrils, airways and lungs and wiping out the virus before it can cause infection or disease.

However, as SARS-CoV-2 mutates, these highly specific antibodies are less able to recognize new viral variants—especially if the changes occur on the virus's spike protein, where the vaccine's antibodies bind. This was especially apparent during the recent wave of the SARS-CoV-2 omicron variant, which has a staggering 37 mutations on its spike protein, making it more able to evade antibodies targeting the original virus's spike protein.

"The biggest problem right now is that none of our current COVID-19 vaccines give complete protection against infection from emerging variants, especially the omicron sublineages BA.1 and BA.2," Suresh says.

That's where T cells can help. Killer T cells aid the immune system by hunting and eliminating "virus factories"—infected cells, says Suresh. So, when antibodies cannot neutralize the virus prior to infection, T cells can clear it quickly, causing mild or no noticeable symptoms.

With this information in hand, the UW–Madison research team, co-led by Suresh and professor of pathobiological sciences Jorge Osorio and assisted by scientist Brock Kingstad-Bakke and doctoral student Woojong Lee, explored how T cells and antibodies can work to prevent COVID-19 infection altogether.

The researchers developed an experimental protein-based vaccine containing the unmutated version of the spike protein from the original SARS-CoV-2 virus. This vaccine was also designed to elicit a strong T cell response to the viral spike protein, allowing the lab to test the extent to which T cells can protect against COVID-19 infection in the presence and absence of virus neutralizing antibodies.

After injecting mice models with their vaccine, researchers then exposed them to two SARS-CoV-2 variants and tested their susceptibility to infection under different conditions.

While vaccine-stimulated antibodies were unable to neutralize the mutated SARS-CoV-2 variants, mice were still immune to COVID-19 caused by the mutated viruses, due to action by T cells that were induced by the vaccine.

Unlike antibodies, T cells are able to detect unfamiliar strains of virus because the viral fragment that they recognize does not change considerably from one variant to the next.

This work has important implications for future T cell-based vaccines that could provide broad protection against emerging SARS-CoV-2 variants. The experimental vaccine is protein-based and designed to evoke a strong T cell response, differentiating it from currently available mRNA vaccines.

Now, the Suresh lab is studying how exactly T cells defend against SARS-CoV-2 and whether commercially available COVID-19 vaccines may induce these same mechanisms of T cell immunity to protect against emerging variants when the virus dodges established antibodies.

"I see the next generation of vaccines being able to provide immunity to current and future COVID-19 variants by stimulating both broadly-neutralizing antibodies and T cell immunity," Suresh says.
 

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Scientists identify characteristics to better define long COVID
by National Institutes of Health
May 16, 2022

A research team supported by the National Institutes of Health has identified characteristics of people with long COVID and those likely to have it. Scientists, using machine learning techniques, analyzed an unprecedented collection of electronic health records (EHRs) available for COVID-19 research to better identify who has long COVID. Exploring de-identified EHR data in the National COVID Cohort Collaborative (N3C), a national, centralized public database led by NIH's National Center for Advancing Translational Sciences (NCATS), the team used the data to find more than 100,000 likely long COVID cases as of October 2021 (as of May 2022, the count is more than 200,000). The findings appeared May 16 in The Lancet Digital Health.

Long COVID is marked by wide-ranging symptoms, including shortness of breath, fatigue, fever, headaches, "brain fog" and other neurological problems. Such symptoms can last for many months or longer after an initial COVID-19 diagnosis. One reason long COVID is difficult to identify is that many of its symptoms are similar to those of other diseases and conditions. A better characterization of long COVID could lead to improved diagnoses and new therapeutic approaches.

"It made sense to take advantage of modern data analysis tools and a unique big data resource like N3C, where many features of long COVID can be represented," said co-author Emily Pfaff, Ph.D., a clinical informaticist at the University of North Carolina at Chapel Hill.

The N3C data enclave currently includes information representing more than 13 million people nationwide, including nearly 5 million COVID-19-positive cases. The resource enables rapid research on emerging questions about COVID-19 vaccines, therapies, risk factors and health outcomes.

The new research is part of a related, larger trans-NIH initiative, Researching COVID to Enhance Recovery (RECOVER), which aims to improve the understanding of the long-term effects of COVID-19, called post-acute sequelae of SARS-CoV-2 infection (PASC). RECOVER will accurately identify people with PASC and develop approaches for its prevention and treatment. The program also will answer critical research questions about the long-term effects of COVID through clinical trials, longitudinal observational studies, and more.

In the Lancet study, Pfaff, Melissa Haendel, Ph.D., at the University of Colorado Anschutz Medical Campus, and their colleagues examined patient demographics, health care use, diagnoses and medications in the health records of 97,995 adult COVID-19 patients in the N3C. They used this information, along with data on nearly 600 long COVID patients from three long COVID clinics, to create three machine learning models to identify long COVID patients.

In machine learning, scientists "train" computational methods to rapidly sift through large amounts of data to reveal new insights—in this case, about long COVID. The models looked for patterns in the data that could help researchers both understand patient characteristics and better identify individuals with the condition.

The models focused on identifying potential long COVID patients among three groups in the N3C database: All COVID-19 patients, patients hospitalized with COVID-19, and patients who had COVID-19 but were not hospitalized. The models proved to be accurate, as people identified as at risk for long COVID were similar to patients seen at long COVID clinics. The machine learning systems classified approximately 100,000 patients in the N3C database whose profiles were close matches to those with long COVID.

"Once you're able to determine who has long COVID in a large database of people, you can begin to ask questions about those people," said Josh Fessel, M.D., Ph.D., senior clinical advisor at NCATS and a scientific program lead in RECOVER. "Was there something different about those people before they developed long COVID? Did they have certain risk factors? Was there something about how they were treated during acute COVID that might have increased or decreased their risk for long COVID?"

The models searched for common features, including new medications, doctor visits and new symptoms, in patients with a positive COVID diagnosis who were at least 90 days out from their acute infection. The models identified patients as having long COVID if they went to a long COVID clinic or demonstrated long COVID symptoms and likely had the condition but hadn't been diagnosed.

"We want to incorporate the new patterns we're seeing with the diagnosis code for COVID and include it in our models to try to improve their performance," said the University of Colorado's Haendel. "The models can learn from a greater variety of patients and become more accurate. We hope we can use our long COVID patient classifier for clinical trial recruitment."
 

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FDA: fluvoxamine doesn’t treat COVID-19 — and here’s 27 pages why
The FDA usually doesn’t say why it rejects drugs
By Nicole Wetsman
May 16, 2022, 5:01pm EDT

When the US Food and Drug Administration rejected an antidepressant as a treatment for COVID-19 on Monday, it also released a 27-page memorandum explaining exactly why it wasn’t convinced the drug was effective. It’s an unusual move for the agency, which typically rejects drugs quietly without quite so much publicly available paperwork.

The antidepressant fluvoxamine is a cheap, generic drug that’s been used for decades. Research shows that the drug can also block inflammation in the body. So, some researchers hoped that it could help prevent severe symptoms in patients with COVID-19, some of whom have to cope with inflammation due to overactive immune systems.

Some small and preliminary studies showed that it might be able to reduce the risk of patients with COVID-19 getting seriously sick. But that research wasn’t enough to convince the FDA. The agency said in its memorandum that the studies submitted in support of the drug didn’t do enough to show that it could offer “clinically meaningful outcomes” — reduction in hospitalizations and deaths. The main study, called the Together trial, found that the drug reduced the likelihood a patient would be in the emergency room for longer than six hours. The FDA wasn’t confident that metric was important.

It’s uncommon to get this type of window into the FDA’s decision-making process when it rejects a drug. Most of the time, the decision goes to the pharmaceutical company who made the drug, and it’s kept confidential. Research shows that those companies often don’t announce rejections, and if they do, they don’t say publicly the reason why. People do want to know, though: a survey of adults in the United States published in February found that nearly 90 percent said that they’d want information about why a drug wasn’t approved to be made public.

Notably, the use of fluvoxamine as a COVID-19 treatment wasn’t sent to the FDA by a pharmaceutical company — a group of doctors asked the agency to authorize it. Because it’s an old and generic drug, no pharmaceutical company would profit from taking it through the expensive regulatory process.

One of those doctors, the University of Minnesota infectious disease physician David Boulware, criticized the FDA’s rejection, telling STAT it was “inconsistent.” He noted that the coronavirus antiviral paxlovid is more effective but that it’s not widely available to people in low- and middle-income countries. “It’s not my first choice as a physician but I should have the option,” Boulware said.
 

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FDA rejects antidepressant seen as possible Covid-19 treatment
By Jason Mast
May 16, 2022

The Food and Drug Administration declined Monday to authorize a 30-year-old generic antidepressant as a treatment for Covid-19, dealing a major blow to a small group of doctors who have organized around the pill for months, arguing that it could provide a cheap and accessible way to prevent hospitalizations and death both in the U.S. and around the world.

In an unusual two-page summary — the FDA does not generally disclose the reasoning behind rejections — regulators said that the doctors failed to provide adequate evidence of effectiveness of the drug, called fluvoxamine.

The submission was primarily based on a roughly 1,500-patient randomized, controlled trial in Brazil that found patients who received fluvoxamine early in the course of their disease were 32% less likely than patients who received placebo to be hospitalized or need emergency care of at least six hours. There were also 17 deaths in the fluvoxamine group compared to 25 in the placebo group, although the difference was not statistically significant.

Fluvoxamine can be found at local pharmacies for around $4. When the clinical trial results came out last summer, they produced hopeful headlines about the prospect of using fluvoxamine as a cheap oral treatment for Covid-19 — at a time when other antivirals were not yet on the market.

The FDA, however, said Monday that it was uncertain that the six-hour cutoff the Brazil study used was “a clinically meaningful threshold.”

Meanwhile, the results on hospitalizations and deaths alone were “not persuasive.” Neither, regulators added, was a smaller randomized clinical trial conducted in the U.S. or a number of real-world studies, because they were small, non-randomized, or employed different endpoints.

Regulators also pointed to a pair of larger randomized controlled trials that failed to show the same benefit the Brazil study did.

In a detailed rebuttal submitted last week and shared with STAT, David Boulware, the University of Minnesota infectious disease physician who has led the push to get fluvoxamine authorized as a Covid-19 treatment, said the FDA’s logic was “inconsistent.”

For instance, he noted, the Merck and Pfizer trials for their oral antivirals for Covid — molnupiravir and Paxlovid — also didn’t rely on a conventional definition of hospitalization. Instead, they defined hospitalization as more than 24 hours of “acute care.”

In an interview, Boulware said fluvoxamine could still have applications, even if the Pfizer pill, Paxlovid, is vastly more effective and now filling pharmacy shelves. For example, many high-risk patients can’t take Paxlovid because it could interact with a drug they’re taking to manage another condition.

Fluvoxamine could also be useful in middle- and low-income countries where the Pfizer and Merck pills are not yet widely available, Boulware said. The Merck pill reduces the risk of hospitalization from Covid-19 by around 30%, according to company clinical trials.

“It’s not my first choice as a physician but I should have the option,” Boulware said.

Fluvoxamine was unusual among experimental Covid-19 medicines. Because it was generic, no drug company stood to profit from bringing it to regulators, which can be a costly and time-consuming process.

Instead, it was championed by Boulware and a group of physicians and researchers, who saw it as the easiest path to cheaply preventing Covid-19 at a time when the only drugs available to prevent hospitalization from Covid-19 were monoclonal antibodies, which have to be injected or infused over an extended period.


Their efforts offered a test for how easily physicians could get a drug through regulators in a crisis without the support of patents or a pharma sponsor.

With the new drugs now available, Boulware acknowledged fluvoxamine is less crucial. But he said it could have been hugely useful during the Omicron surge in December, when he initially filed the paperwork for authorization.

At the time, neither Paxlovid nor molnupiravir were widely available and the new variant had rendered most monoclonals useless.

“This was highly relevant back in December, when we had no Paxlovid, no antibodies,” he said. “Now it’s less relevant.”

Still, he said, more trials are ongoing. And if more evidence comes in, he and other researchers may resubmit. Trials for other repurposed medicines are also ongoing.
 

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How the FDA justified rejecting an EUA for fluvoxamine
The drug works great. But the FDA doesn't want anyone to know that. Why? Because they are corrupt. They will never agree to debate me on that.
Steve Kirsch
7 hr ago

Summary

Fluvoxamine has a systematic review and meta-analysis published in a top medical journal. You cannot get any better than that. It’s the “gold standard” of medical evidence.

So when a group of scientists applied for an FDA for fluvoxamine, what did the FDA do? They rejected the drug for “insufficient evidence” just like they always do for ivermectin.

Everyone is stunned, but nobody is surprised. How can the FDA say a drug which meets the “gold standard” of evidence has “insufficient evidence”?

The FDA approved Molnupiravir which was less effective. Why not fluvoxamine?

ICER, a non-profit known as the nation’s drug pricing watchdog, did a review of the evidence and determined that fluvoxamine evidence is superior to Molnupiravir.

It can’t be more clear than this. The reason is pure corruption.

But I know something else that few other people know, thanks to a source at the NIH: the NIH was planning to approve fluvoxamine months ago, but they got a call from the FDA telling them not to.

This is how science works today.

This post was written to memorialize the corruption.

Background documents
  1. Original Boulware EUA application
  2. JAMA systematic review and meta analysis It doesn’t get any better than this. This is the “gold standard of evidence based medicine”
  3. FDA official fluvoxamine rejection
  4. Article about the rejection (Stat News)
  5. Article about the fluvoxamine rejection (The Verge)
  6. NIH is still unsure whether fluvoxamine should be used to treat COVID (article I did after the TOGETHER trial). The NIH wrote a bullshit rejection because the FDA told them not to approve it.
  7. The ICER independent review showed fluvoxamine is more effective than Molnupiravir:
    Angela Reiersen, MD, MPE @AngelaReiersen
    ICER: “… committee votes 11-2 that the evidence is not adequate to demonstrate a net health benefit for molnupiravir over symptomatic care alone; Paxlovid and fluvoxamine receive more favorable votes”
    May 16th 2022
    6 Retweets30 Likes
Using fluvoxamine

Read this article I wrote about using fluvoxamine correctly for COVID. It is an amazing drug and is a very simple safe way to avoid long-haul COVID symptoms.

Taking apart the FDA’s argument

These people never called the researchers whose trials they claimed showed no effect.

The trials that were abandoned for futility weren’t getting events because the patients were given standard of care meds. So there were too few events in the placebo group and they weren’t recruiting fast enough. So the drug had no chance of working (since there were no events), so the trial was stopped for futility, NOT because the drug doesn’t work. All the researchers are convinced the drug works.

Fluvoxamine has at least a 30% hospitalization and death benefit.

Expect similar things to happen when Eiger applies for an EUA for interferon lambda, a drug with a 89% efficacy in phase 3 trials.

It’s not about the science. It never was.
 

psychgirl

Has No Life - Lives on TB
Backing up a bit, I’m wondering just exactly WHAT medications are being dispensed to the people in NK?
I’m curious as to what they know and believe, works. Since they rejected the vaxx, I wonder if they’ve embraced treatments such as Ivermection?
But I suspect they’re relying on treating symptomatically.

And yes, that country is a perfect study in how herd immunity will or might behave with this virus! I just wish we knew the true goings on and statistics, which will probably never happen. What a shame!
 
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