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Continuing his relentless effort to expose Anthony Fauci forlying about funding dangerous civilisationending gain of function research, Senator Rand Paul warned Sunday that the head of the National Institute of Allergy and Infectious Diseases will never stop lying about it and should immediately be fired.

In an interview with Axios, Paul urged Hes probably never going to admit that he lied, adding Hes gonna continue to dissemble, and try to work around the truth, and massage the truth.

He [Fauci] should be fired," Paul emphasised, adding just for lack of judgment if nothing else.

Paul reiterated Were calling for an investigation and hearings on this. Weve been calling for that for months.

There has been a great deal of resistance from the Democrat side. Do we not want to know the origin of the virus or to know if it came from a lab? Particularly since this research still goes on, the Senator further urged.

Watch:

Responding to Paul, Fauci claimed in an interview with ABC News that Hes absolutely incorrect. Neither I nor Dr. Francis Collins, the director of the NIH, lied or misled about what weve done.

Fauci further claimed that it ismolecularly impossible for those viruses that were worked on to turn into SARS-CoV-2,referring to the manipulation in the Chinese labs.

They were distant enough molecularly that no matter what you did to them, they could never, ever become SARS-CoV-2, Fauci claimed:

During the interview, Fauci also stated Theres all of this concern about whats gain of function or whats not.

Which is particularly interesting since he keeps changing the definition:

* * *

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Rand Paul: Fauci Will Never Stop Lying; Fire Him Now ...

For half a year, Anthony Fauci, the nation's top infectious-disease official, and Kentucky senator and physician Rand Paul have been locked in a battle over whether the National Institutes of Health funded dangerous "gain of function" research at the Wuhan Institute of Virology (WIV) and whether that research could have played a role in the pandemic. Against Senator Paul's aggressive questioning over three separate hearings, Dr. Fauci adamantly denied the charge. "The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology," he said in their first fracas on May 11, a position he has steadfastly maintained.

Recently, however, a tranche of documents surfaced that complicate Dr. Fauci's denials. The documents, obtained by Freedom of Information Act requests, show that the NIH was funding research at the Wuhan lab that involved manipulating coronaviruses in ways that could have made them more transmissible and deadly to humanswork that arguably fits the definition of gain-of-function. The documents establish that top NIH officials were concerned that the work may have crossed a line the U.S. government had drawn against funding such risky research. The funding came from the NIH's National Institute of Allergy and Infectious Diseases (NIAID), which Dr. Fauci heads.

The resistance among Dr. Fauci and other NIH officials to be forthcoming with information that could inform the debate over the origins of COVID-19 illustrates the old Watergate-era saw that the coverup is often worse than the crime. There's no evidence that the experiments in question had any direct bearing on the pandemic. In the past, Dr. Fauci has made strong arguments for why this type of research, albeit risky, was necessary to prevent future pandemics, and he could have done so again. But the NIH has dragged its feet over FOIA requests on the matter, handing over documents only after The Intercept took the agency to court.

The apparent eagerness to conceal the documents has only raised suspicions about the controversial research and put the NIH on the defensive. Fauci told ABC, "neither I nor Dr. Francis Collins, the director of the NIH, lied or misled about what we've done." The episode is a self-inflicted wound that has further eroded trust in the nation's public health officials at a time when that trust is most important.

While Dr. Fauci takes the political heat, the revelations center on another figure in this drama: Peter Daszak, president of the private research firm EcoHealth Alliance, which received the $3 million NIH grant for coronavirus research and subcontracted the gain-of-function experiments to the Wuhan lab. The activities of Daszak and EcoHealth before the pandemic and during it show a startling lack of transparency about their work with coronaviruses and raise questions about what more there may be to learn.

From the start, Daszak has worked vigorously to discredit any notion that the pandemic could have been the result of a lab accident. When the media was first grappling with the basics of the situation, Daszak organized a letter in the prestigious medical journal The Lancet from 27 scientists, to "strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin," and got himself appointed to the WHO team investigating COVID origins, where he successfully argued that there was no need to look into the WIV's archives.

What Daszak didn't reveal at the time was that the WIV had been using the NIH grant money to genetically engineer dozens of novel coronaviruses discovered in bat samples, and that he knew it was entirely possible that one of those samples had contained SARS-CoV-2 and had infected a researcher, as he conceded to the journal Science in a November 17 interview: "Of course it's possiblethings have happened in the past."

The NIH fought for more than a year to keep details about the EcoHealth grant under wraps. The 528 pages of proposals, conditions, emails, and progress reports revealed that EcoHealth had funded experiments at the WIV that were considerably riskier than the ones previously disclosed.

The trouble began in May 2016, when EcoHealth informed the NIH that it wanted to conduct a series of new experiments during the third year of its five-year grant. One proposed producing "chimeras" made from one SARS-like virus and the spike proteins (which the virus uses to infiltrate animal cells) of others, and testing them in "humanized" mice, which had been genetically engineered to have human-like receptors in their lungs, making them better stand-ins for people. When such novel viruses are created, there is always a risk they will turn out to be dangerous pathogens in their own right.

Another risky experiment involved the MERS virus. Although MERS is lethalit kills 35 percent of those who catch itit's not highly transmissible, which is partly why it has claimed fewer than 900 lives so far. EcoHealth wanted to graft the spikes of other related coronaviruses onto MERS to see how that changed its abilities.

Both experiments seemed to cross the gain-of-function line. NIH program officers said as much, sending Daszak a letter asking him to explain why he thought they didn't.

In his reply, Daszak argued that because the new spikes being added to the chimeras were more distantly related to SARS and MERS than their original spikes, he didn't anticipate any enhanced pathogenicity or infectiousness. That was a key distinction that arguably made them exempt from the NIH's prohibition on gain-of-function experiments. But, of course, one never knows; as a precaution, he offered that if any of the chimeric viruses began to grow 10 times better than the natural viruses, which would suggest enhanced fitness, EcoHealth would immediately stop all experiments, inform the NIH program officers, and together they'd figure out what to do next.

The NIH accepted Daszak's terms, inserting his suggestions into the grant conditions. Scientists at WIV conducted the experiments in 2018. To their surprise, the SARS-like chimeras quickly grew 10,000 times better than the natural virus, flourishing in the lab's humanized mice and making them sicker than the original. They had the hallmarks of very dangerous pathogens.

WIV and EcoHealth did not stop the experiment as required. Nor did they let the NIH know what was going on. The results were buried in figure 35 of EcoHealth's year-four progress report, delivered in April 2018.

Did the NIH call Peter Daszak in to explain himself? It did not. There are no signs in the released documents that the NIH even noticed the alarming results. In fact, NIH signaled its enthusiasm for the project by granting EcoHealth a $7.5 million, five-year renewal in 2019. (The Trump administration suspended the grant in 2020, when EcoHealth's relationship with the WIV came under scrutiny.)

In a letter to Congress on October 20, the NIH's Principal Deputy Director, Lawrence Tabak, acknowledged the screwup, but he placed the blame on EcoHealth's door, citing its duty to immediately report the enhanced growth that had occurred: "EcoHealth failed to report this finding right away, as was required by the terms of the grant." In a follow-up interview with the Washington Post, NIH Director Francis Collins was more blunt: "They messed up here. There's going to be some consequences for EcoHealth." So far, the NIH has not elaborated on what those consequences might be.

As damning as the NIH grant documents are, they pale in comparison to another EcoHealth grant proposal leaked to the online investigative group DRASTIC in September. In that 2018 proposal to the Defense Advanced Research Projects Agency, a Pentagon research arm, EcoHealth sketched an elaborate plan to discover what it would take to turn a garden-variety coronavirus into a pandemic pathogen. They proposed widely sampling Chinese bats in search of new SARS-related viruses, grafting the spike proteins from those viruses onto other viruses they had in the lab to create a suite of chimeras, then, through genetic engineering, introducing mutations into those chimeras and testing them in humanized mice.

One piece of the proposal was especially Strangelovian. For years, scientists had known that adding a special type of "cleavage site" to the spike could supercharge a virus's transmissibility. Although many viruses in nature have such sites, neither SARS nor any of its cousins do. EcoHealth proposed incorporating human-optimized cleavage sites into the SARS-like viruses it discovered and testing their infectiousness. Such a cleavage site, of course, is exactly what makes SARS-CoV-2 wildly more infectious than its kin. That detail was the reason some scientists initially suspected SARS-CoV-2 might have been engineered in a lab. And while there's no proof that EcoHealth or the WIV ever actively experimented with cleavage sitesEcoHealth says that "the research was never conducted"the proposal makes it clear that they were considering taking that step as early as 2018.

DARPA rejected the proposal, listing among its shortcomings the failures to address the risks of gain-of-function research and the lack of discussion of ethical, legal, and social issues. It was a levelheaded assessment. What's remarkable is that much of the same work that crossed a line for the Department of Defense was embraced by the National Institutes of Health.

The NIH and EcoHealth have asserted that none of the engineered viruses created with the NIH grant could have become SARS-CoV-2. On that, everyone agreesthe viruses are too distantly related. But the detailed recipe in the DARPA application is a blueprint for doing just that with a more closely related virus.

In September, scientists from France's Pasteur Institute announced the discovery of just such a virusSARS-CoV-2's closest known relativein a bat cave in Laos. Although still too distant from SARS-CoV-2 to have been the direct progenitor, and lacking the all-important cleavage site, it was a kissing cousin.

The discovery was hailed by some scientists as evidence that SARS-CoV-2 must have had a natural origin. But the plot turned in November, when another trove of NIH documentsreleased in response to a FOIA request by the White Coat Waste Projectbrought the evidence trail right to EcoHealth's doorstep.

In 2017, EcoHealth had informed the NIH that it would be shifting its focus to Laos and other countries in Southeast Asia, where the wildlife trade was more active, relying on local partner organizations to do the sample collecting and to send the samples to the WIV for their ongoing work. EcoHealth told Newsweek that it did not directly undertake or fund any of the sampling in Laos. "Any samples or results from Laos are based on WIV's work, funded through other mechanisms," says a company spokesman.

Regardless of who paid for the collecting portion of the project, it's clear that for years, a large number of bat samples from the region that harbors viruses similar to SARS-CoV-2 were sent to the WIV. In other words, EcoHealth's team was in the right place at the right time to have found things very close to SARS-CoV-2 and to have sent them to Wuhan. Because there's a lag of several years between when samples are collected and when experiments involving those viruses are published, the most recent papers from EcoHealth and the WIV date to 2015. The identity of the viruses found between 2016 and 2019 are known only to the two organizations, neither of which has been willing to share that information with the world.

A lack of evidence proves nothing, but neither does it put EcoHealth's or the WIV's actions in the early days of the pandemic in a good light. Why choose not to share valuable information on SARS-like coronaviruses with the world? Why not explain your projects and proposals and give scientists access to the unpublished virus sequences in your databases?

For whatever reason, they chose crisis-management mode instead. The WIV went into lockdown. Databases were taken offline. Daszak launched his preemptive campaign to prevent anyone from looking behind the curtain. And EcoHealth and the NIH tried hard to keep the details of their collaboration private.

Congressional inquiries focusing on Dr. Fauci and the NIH's decisions to fund unnecessarily risky research by a lab in Wuhan are probably forthcoming if, as appears increasingly likely, Republicans take control of Congress after the 2022 midterms. While it's important to understand how the NIH came to use such poor judgment in its dealings with EcoHealth Alliance, that won't tell us much about the WIV's research in the months leading up to the pandemic, especially since China is not likely to open its books. Answers are more likely to lie in the records of EcoHealth Alliance. Republicans and Democrats alike should be eager to find them.

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How Dr. Fauci and Other Officials Withheld Information on China's Coronavirus Experiments - Newsweek

A bipartisan group of 84 House members will send a letter to President Joe Biden on Wednesday requesting that the administration push for the inclusion of $1 billion in supplemental funding for Israels Iron Dome missile-defense system in an upcoming government spending bill, Jewish Insider has learned.

The House passed the Iron Dome funding as a standalone item in September, but it remains stalled in the Senate, where Sen. Rand Paul (R-KY) is blocking a fast-tracked approval process.

The House members 76 Democrats and eight Republicans led by Rep. Josh Gottheimer (D-NJ) will urge Biden in their letter, a draft of which was obtained by JI, to specifically request that Congress include supplemental funding for Israels Iron Dome in an appropriations bill enacted before the years end including in any anomalies you may request to a new continuing resolution.

Government funding is currently set to run out on Dec. 3 just days after Congress returns from its Thanksgiving recess, requiring the House and Senate to pass either a series of appropriations bills setting government funding levels for the year or a shorter-term continuing resolution (which would carry forward previously set funding levels) before that date to avert a government shutdown.

The president can request anomalies in a continuing resolution alterations to current funding levels for specific issues, although final decisions on what is included in any appropriations bill or continuing resolution are up to Congress.

Senate Democrats included the Iron Dome funding in their draft of the 2022 defense appropriations bill released in mid-October. A source close to the appropriations committee told JI that this was a backup plan to efforts to pass the funding as a standalone measure.

The letter follows clashes over attempts by House Democratic leadership to include the Iron Dome funding in a continuing resolution in September. No Republicans supported that continuing resolution because it also increased the debt limit. The federal government is set to hit another debt limit in the coming weeks, but it is unclear how congressional leadership plans to address it.

Originally posted here:
84 House members call on Biden to push Iron Dome funding in year-end appropriations bill - Jewish Insider

NEW YORK Recent guidance from the US Food and Drug Administration regarding the oversight of laboratory-developed tests has caused mixed reactions from industry stakeholders, including laboratorians, test manufacturers, and professional organizations.

Last week, the FDA announcedthat the US Department of Health and Human Services had withdrawn a policy restricting the FDA's ability to review laboratory-developed tests for SARS-CoV-2. In effect, it reverses the policy, originally established in August 2020, that directed the agency not to enforce premarket review requirements for LDTs without notice-and-comment rulemaking.

As a result of the 2020 policy, test developers were able to distribute their validated tests as LDTs without objection from the FDA as long as the agency was notified.

In October 2020, the FDA also decided not to review Emergency Use Authorizations for LDTsbut was directed by HHS to remove that policy after concerns from labs over reimbursement and liability.

LDT regulation has long been an issue in the diagnostic industry, with confusion surrounding who is in charge the FDA or the US Centers for Medicare and Medicaid Services of monitoring and reviewing such tests before they reach the market, and last week's decision is unlikely to be the last word on the matter.

The lab industry has said that LDTs are regulated under the Clinical Laboratory Improvement Amendments, which is executed by CMS. The FDA, however, has said that the regulation of LDTs has always fallen within its purview, as well.

Two competing bills are floating around Congress that takeopposite sides of the argument whether the FDA should have oversight of LDTs. In May, Sen. Rand Paul, R-Kentucky, reintroduced the Verified Innovative Testing in American Laboratories, or VITAL, Act of 2021, that would block the FDA from regulating LDTs.

A month later, though, the Verifying Accurate, Leading-edge ICVT Development, or VALID, Act of 2021 was reintroduced in the US House of Representatives and Senate to solidify the FDA's authority to regulate LDTs and create a new regulatory framework for the tests.

Part of the FDA's reasoning for reviewing and approving new tests, an agency official said, is to make sure the tests are "accurate and reliable." The official noted that the FDA has not enforced premarket review on LDTs unless there are safety concerns, and during the COVID-19 pandemic, a lab has been able to use its LDT while the agency reviews its application for Emergency Use Authorization.

He added that the agency has generally not enforced its premarket review authority unless there is an issue with a test on the market and that the guidance continues the FDA's "longstanding approach" on LDTs. It's a "restoration of FDA's way of doing business," the official said.

However, that gave little assurance to laboratory organizations and laboratorians who worry that the review process will put undue burden on labs trying to make their tests available to patients.

Tom Sparkman, senior VP of government affairs and policy at the American Clinical Laboratory Association, said that the shifting of the requirements puts test developers at a disadvantage, since they can't be sure what the standards are or if they'll be changed without public comment.

He said there's "concern[s] when we see sudden shifts" in LDT policy, and that the "un-transparent gyrations" from the FDA make it difficult for labs to predict how tests they've developed will reach the market and patients.

The new guidance, Sparkman said, will impact laboratories' abilities to bring forward LDTs and will impede the development of innovative tests.

Sparkman also noted that the FDA's relaxing of regulatory standards in February 2020 allowed labs to significantly increase testing capacity during the height of the pandemic by bypassing the more rigorous FDA approval process.

Jonathan Myles, chair of the College of American Pathologists' Council on Government and Professional Affairs, similarly echoed worries about the FDA's recent guidance and said in an email that the organization is "concerned with dramatic policy changes that require pathologists and clinical laboratories to alter operations which further exacerbates personnel shortages that clinical laboratories are currently experiencing."

As the rules are implemented, Myles said he sees potential for "increased testing challenges, since patients often seek traditional testing to confirm results from point-of-care and at-home testing."

And Mark Birenbaum, administrator of the National Independent Laboratory Association, said that there's a concern that FDA oversight will "slow down the introduction of new tests," particularly in an emergency.

The traditional FDA process is "expensive and onerous," especially for labs with fewer resources, he said, adding it causes confusion for labs that aren't familiar with the FDA process, since it's more involved than the usual CLIA pathway, he said.

However, Birenbaum noted that the original policy restricting the FDA's oversight caused problems for laboratories that needed EUAs to get reimbursement from payors for their COVID-19 tests, The new revised policy, which allows labs to receive EUAs, could help ensure that labs get reimbursed for such tests.

Ultimately, Birenbaum said that the withdrawal of HHS' guidance doesn't resolve any of the issues facing labs and is simply a return "to where we were."

Others questioned whether the FDA's guidance foreshadows its LDT plans for the future, including Kelly Wroblewski, the director of infectious disease at the Association of Public Health Laboratories, who said that this "has always been our understanding of how FDA intends to operate in a public health emergency," and that it could signal how the FDA will regulate broader LDTs after the pandemic ends.

The American Association for Clinical Chemistry also is less concerned with the specific guidance and more concerned about "the precedent it may set for FDA involvement in LDT policy moving forward," Stephen Master, president of the AACC, said via email.

"In other words, members are concerned that if the FDA chooses to claim authority over coronavirus LDTs, then it may also use this guidance as a means of claiming broader authority over non-coronavirus LDTs as well," he continued.

He noted that there are questions surrounding why the FDA continues to use guidance to set its LDT policy, rather than going through the normal rulemaking process, which includes a public comment period.

James Versalovic, pathologist-in-chief at Texas Children's Hospital, saidthat the existence of CLIA standards already ensures laboratory-developed tests are highly accurate before they reach patients. "The reality is we need the FDA to monitor efficacy and safety of diagnostics, medications, and vaccines," he said. "But we have to ask ourselves do we have a system that ensures high quality diagnostic testing? And the simple answer is yes," he said, referring to CLIA.

"With additional regulatory hurdles on LDTs many hospitals won't be able to develop tests," he said. "We'd be entirely dependent on big industry to supply tests, and frankly, we will lose the innovative capacity that's provided by so many hospitals and healthcare systems on the front lines."

Dwayne Breining, executive director at Northwell Health Labs, sees it differently, however, and said that the guidance will likely not have a significant impact on his lab, as any of its tests would meet the FDA standards and be able to pass the review process.

The lack of FDA review was a "barn door" that "let a lot of tests through that are overall just much less accurate than would normally be let through," and the new guidance will "tighten up that process," he said. He expects the change to affect more "fringe developers" of laboratory tests, including "entities [that] got into the testing market who don't normally either do diagnostic testing or manufacture diagnostic test[s]."

The new guidance, he said, doesn't hamper traditional lab testing, since professional labs are "already running good tests," but rather is "weeding out these less accurate tests."

"A little bit of regulation is good, as long as it doesn't hamper the good labs getting the testing up and running that they need to get to meet any sort of clinical need," he said.

EUA refocus

Another aspect of the FDA's guidance document relates to the agency's priorities regarding EUA submissions. The FDA said that its focus when reviewing EUA submissions will largely be on at-home and point-of-care tests that can scale up rapidly, although it will also consider molecular lab-based tests that can increase manufacturing capacity.

That change could lead to a backlog in reviews of tests that don't meet the FDA's prioritization requirements, something that would have more of an impact on tests from clinical labs.

Mary Steele Williams, the executive director of the Association for Molecular Pathology, said via email that "it is very worrisome that FDA intends to review only those EUAs it has determined to be high priority tests, which by its own definition will likely exclude many [LDTs] performed at clinical laboratories in academic medical centers and community hospitals/medical centers."

She added that "the COVID-19 pandemic has revealed that there are many benefits to diagnostic test results being available in hours rather than days," and that the organization is concerned that "as the number of cases plateau or begin to increase, the country is poised to repeat the same mistakes made at the outset of the pandemic with FDA policies preventing sufficient capacity of crucial diagnostic tests from clinical laboratories that are located where patients receive care and can meet the need for rapid results."

However, manufacturers of rapid tests, such as LumiraDx, welcome news of the FDA's change in focus.

Pooja Pathak, LumiraDx's chief product officer, said that it's encouraging that the new guidance "recognizes point-of-care testsas a potential means to significantly increase testing capacity and accessibility to accurate and reliabletests."

Indeed, overall, test manufacturers saw last week's news as a positive. In a statement, Scott Whitaker, president and CEO of the Advanced Medical Technology Association,supported the new guidance, saying that the organization has "long supported the idea that all diagnostic test developers whether they make in vitro or laboratory-developed tests should be subject to the same FDA standards and processes."

Kyle Mikson, an analyst with Canaccord Genuity who covers the diagnostic industry, said that companies with rapid platforms are better positioned in the market in light of the guidance, and noted that some companies may shift away from COVID-19 testing if their tests don't meet the FDA's new priorities, particularly those that have launched antibody tests which have seen a much less significant demand than other tests.

Rapid platforms are the "next stage" of testing, and the move could lead larger companies, such as Roche, Becton Dickinson, Hologic, or Abbott, to acquiresmaller firms with rapid tests, Mikson said. In addition, companies with tests that are based more in hospitals may need rapid tests to compete in the market, he said.

Mikson also said that there are huge risks for any company or lab that releases a test without approval, since there's a fear that one day the FDA may request further data. He added that he thinks a lot of companies are doing more rigorous validation than is required, just in case the regulations change again.

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FDA, HHS Guidance on COVID-19 LDTs Draws Mixed Reactions from Industry Stakeholders - 360Dx

WASHINGTON (The Borowitz Report)As an event dreaded by millions draws near, Dr. Anthony Fauci is urging all Americans to use COVID-19 as an excuse to skip Thanksgiving with horrible relatives.

Speaking from his office at the National Institutes of Health, Fauci said that the COVID-19 excuse could help prevent a seasonal surge in exasperation and seething rage associated with the Thanksgiving holiday.

COVID-19 could get you off the hook this year, Fauci said. Consider this a doctors note from me.

By using the pandemic as justification for skipping Thanksgiving, Americans can spare the feelings of relatives they despise, the esteemed virologist said.

Tell your aunt from West Virginia that youll miss her, but youll look forward to reading her QAnon theories on Facebook, he advised.

For his part, Fauci said that he intends to employ COVID-19 as an excuse to exempt himself from other unpleasant activities. I plan to use it to avoid seeing Rand Paul, he said.

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Fauci Urges Americans to Use COVID as Excuse to Skip Thanksgiving with Horrible Relatives - The New Yorker