Testing Failures

WARNING:   When we listen to T-RUMP and his COVID COHORTS making Warp Speed Deals and vaccines and antigens,  it gets confusing. It’s not the messaging we are getting from scientists around the world.   When we hear him tell us to open schools and endanger our children, yes,  we will, when every Congressional member’s and Senators grand children are sitting right to ours.

When he tells us masks are not helping,  tell him he is a frickin liar.  And include his partner.  We all have partners, Batman and Robin, Superman and Super girl, Laurel and Hardy, Adolf and Eva,  Boris and Natasha, Rocky and Bullwinkle and Donald J T-RUMP  has  Dr. Mike “ Josef Mengele Pence and Dr / Scott Atlas too.  

Turn the TV off, watch something else, FOX news is brainwashing… and your brain it appears had a rough art in life.   Anything he says whether it’s a threat, promise, or a Chicken in every pot. There are no free chickens except those in the GOP Senate alongside the Neanderthals, Cro-Magnons and Vermin.

Abbott Laboratories Failed 
T-RUMPS deal for 150 million rapid COVID-19 tests the White House promoted last month as a potential game-changer in battling the pandemic fails to fix the lack of an overarching strategy for a new phase of testing the nation needs to embrace, multiple health experts and state and local officials say.   English it failed…

The T-RUMP administration’s purchase of the new Abbott Laboratories antigen tests, which can detect the virus in 15 minutes, was hailed by White House press secretary Kayleigh McEnany as a major development that would help Americans get back to work and school. ( More Lies From Mini-Mouth, she needs to shut up) 

But without detailed federal guidance, states and cities remain divided, and some of them stifled, on how to best to use those types of rapid tests and others for the testing technique known as “screening.”   Did the tests fail or did the government fail, very inquiring minds want to know…

Screening involves routinely testing people whether or not they have symptoms. Because an estimated 40% of coronavirus infections are asymptomatic, according to the Centers for Disease Control and Prevention, the idea is to focus on groups, such as those in nursing homes, schools or higher-risk workplaces, and use point-of-care tests or other techniques to test everyone in those groups and isolate the infected. Epidemiologists say communities should implement screening to limit outbreaks. 

The Government Not Helpful As Usual…
New Orleans Health Director, Dr Jennifer Avegno said she has been working with local officials on a plan that would allow for routine testing of teachers in her city, but without overarching federal guidance, she said, “ It’s been very challenging as a local health leader to communicate what we believe to be best practices." 

Fewer than 25 million tests are now reported monthly but a basic screening strategy will require as many as 200 million each month -- far more than the 150 million Abbott antigen tests purchased by the government, according to a report by the Duke-Margolis Center for Health Policy, with the Rockefeller Foundation and others.

"What we don't have is a national strategy that we're actually implementing to get those asymptomatic screening tests to everybody who most needs them right now to reopen schools safely, to reopen the economy as effectively as possible," said Dr. Mark McClellan, a former commissioner of the Food and Drug Administration under President George W. Bush and the Duke-Margolis Center director.

He Talks, Lies, No Action…
President Donald T-RUMP has questioned the need for broad COVID-19 testing, tweeted in June that more COVID-19 tests can make the country “ look bad” and suggested that he instructed his administration to slow down coronavirus testing. On Tuesday, he claimed "herd mentality" could help the disease dissipate, even though many medical experts argue that a herd-immunity approach could lead to millions of deaths.

Admiral Brett Giroir, who oversees federal COVID-19 testing efforts, said last Thursday he has “ Never been told to slow down testing” and said that he supports asymptomatic screening efforts. 

A spokesperson for the Department of Health and Human Services, Mia Heck, said in a statement that the administration is continuing to aggressively invest in point-of-care testing, that allotments of the Abbot antigen tests to states will begin this month, and that "the public can expect additional guidance on screening to be forthcoming." 

Heck added that the federal government awarded about $10 billion to states, territories and local governments to support their testing plans, and that those funds are still largely available for states to draw upon. 

What The Tests Are Needed For…
The calls for a national screening strategy come as the US has been performing an average of nearly 704,000 tests per day since the beginning of August, according to data from the COVID Tracking Project.

That number marks exponential growth since the start of the pandemic. But the nation's testing infrastructure has primarily been wielded for diagnostic purposes -- meaning PCR tests, which are known to be highly accurate, have been used to determine whether individuals who feel sick or think they have been exposed to the virus are actually infected. 

A. David Paltiel, a professor at the Yale School of Public Health, argues that in order to use testing as a tool for outbreak control as opposed to individual diagnostic purposes, communities must frequently test groups of people in order to catch asymptomatic spreaders. 

In a study that examined the spread of the virus among a hypothetical cohort of students, Paltiel found that screening people every couple of days with a less sensitive test was more effective for controlling an outbreak than using more sensitive tests less frequently.

"The most important variable was frequency ... and again, the reason frequency matters so much is because of these silent spreaders," said Paltiel, who said rapid, point-of-care antigen-based tests could prove more effective for catching asymptomatic cases within groups even though they are less sensitive than lab-based PCR tests because they are faster and cheaper. 

While the CDC has issued some guidance on antigen tests and their use in nursing homes, the government has not issued extensive guidance for comprehensive coronavirus screening strategies in general. 

Moreover, recent comments and guidance from the Trump administration have created questions and confusion around asymptomatic testing in general. 

In August, the CDC issued guidelines that said some people without symptoms may not need to be tested even if they've been in close contact with infected people. CDC Director Dr. Robert Redfield said Wednesday that the CDC has never recommended against asymptomatic testing, and he said the CDC is currently working on a clarification document on testing. 

States Offering Tests, But Different Strategies, Limited Resources

  • Thirty-four out of 37 states and Washington, DC, told CNN they still recommend or offer tests to people who have been exposed to Covid-19 and are asymptomatic.   
  • Oregon recommends people exposed to the virus quarantine for 14 days and get tested if they develop symptoms. 
  • Rhode Island said each situation is managed on a case-by-case basis. 
  • Florida's Department of Health said people who are in brick-and-mortar schools or other congregate settings and develop symptoms should get a Covid-19 test. The department said Florida follows CDC recommendations that testing “should be considered" for asymptomatic close contacts.
  • But when asked about screening strategies and whether they are planning to use rapid tests like point-of-care antigen tests for such methods, state health departments offered a wider range of responses. 
  • The Vermont Department of Health is conducting routine, facility-wide testing at correctional and congregate care facilities but using lab-based PCR tests to do so, according to a spokesperson.
  • In addition to testing requirements for jails and nursing homes, Michigan requires testing for agricultural and food processing employees and permits that antigen tests be used. 
  • North Carolina issued an order to require biweekly testing of nursing home staff and has saidantigen tests could be considered for individuals with or without symptoms in places like nursing homes.

Others Said They Need More Information, Especially On Antigen Tests.

  • “At this time, we do not have all the specifics on these tests, including their strengths and weaknesses and where they would be most useful," a spokesperson for the Montana Department of Public Health and Human Services said of antigen tests. 
  • Avegene of New Orleans said the city is currently evaluating the feasibility of testing teachers each week with PCR tests, but because they are expensive and cheaper antigen tests are not yet available on large scale, funding is an issue.
  • While county and city health departments have begun thinking about asymptomatic screening, ongoing case surges coupled with limited guidance and resources have kept many from proactively implementing screening strategies, said Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials.
  • “It's really hard to move forward when you're stuck in place," Freeman said. 

Efforts To Move Ahead…

  • Some private organizations and universities have taken it upon themselves to launch screening plans. 
  • Duke University has been using “ Pooled testing" -- the process of mixing several people's samples and examining them in a single test -- to screen students and staff. 
  • The University of Illinois requires students and faculty who participate in on-campus activities to routinely take saliva-based tests processed at a university lab. Those who test positive must quarantine.
  • Rebecca Lee Smith, an epidemiology professor at the University of Illinois who helped develop the program, says such strategies implemented nationwide, along with consistent messaging, could curtail the virus’ spread, but she sees limited federal leadership. 
  • "It is quite frustrating," Smith said. “ National messaging is essential to controlling infectious disease because diseases don't stop at state borders." 
  • Giroir, the Department of Health and Human Services’ assistant secretary for health, has repeatedly insisted the US government has taken every step possible to boost coronavirus testing. “ Everything that can possibly be done has been done,” he said on August 14.   ( That does no mean crap, it means everything T-RUMP wants has been done) 
  • In light of the federal government’s approach to testing, which largely gave states the responsibility of developing their own testing plans, some have banded together to seek testing solutions. 
  • A bipartisan compact of 10 states teamed up with the Rockefeller Foundation to acquire five million antigen tests. Members of the group have been regularly discussing lessons learned about rapid screening tests, according to a Rockefeller Foundation spokesperson. 
  • Blythe Adamson, an advisory council member for Testing for America, a nonprofit formed by scientists and entrepreneurs to help address the testing crisis, said a strong national plan that prioritized certain groups for screening would not only have health benefits but could accelerate economic recovery. 
  • She clarified that she is not calling for all Americans to be regularly tested, but she said the government could help identify pockets of the economy that would benefit most from asymptomatic screening and potentially offer incentives, like tax subsidies, to certain employers that implement screening. 
  • "We've got so many software engineers but is it cost effective to test them all when they can all be working from home? Or is it better to regularly test lower-wage retail workers because we want these retail locations to be open and safe and productive?" Adamson said. “ overnment intervention can help guide the most efficient use of the resources we have available today.”       Oct 21, 8:53 am

👺  Clinical Report  —10.21.2020  The US just saw about 60,000 new Covid-19 cases in a day, triple what the daily average was back in June when restrictions began to ease.  It’s another sign that the US is nearing what experts say is a “rapid acceleration” of the disease. In other words, yes, the fall surge may get worse. Dr. Scott Gottlieb, a former FDA commissioner, says the US is about two to three weeks behind whatever’s happening in Europe. 

And right now, it’s pretty bad. The UK’s daily COVID-19 death toll tripled from Monday to yesterday, and cities like Paris are dealing with curfews and other new restrictions. The Czech Republic seemed to have vanquished the virus in the summer thanks to intense safety measures, but the government is now bringing back a strict mask mandate as daily case counts are far higher than just after the pandemic began. 

 👺  Clinical Test Failures  —  Corrupt Vaccine Company On the Carpet

New York (CNN Business)California biotech company Vaxart, which is working on a Covid-19 vaccine, is under federal investigation and is being sued by a number of investors for allegedly exaggerating its involvement in the US government's Operation Warp Speed program for developing Covid-19 vaccines and treatments.

Vaxart stated in an October 14 Securities and Exchange Commission filing that it's being investigated by the SEC and federal prosecutors, and that it was served with a grand jury subpoena in July from the US District Court for the Northern District of California.

In June, Vaxart (VXRT) issued a press release that said "Vaxart's Covid-19 Vaccine Selected for the US Government's Operation Warp Speed." The news helped propel Vaxart's stock price to nearly $17, up from approximately $3, and hedge fund Armistice Capital, which partly controlled Vaxart, sold shares for a profit of more than $200 million, according to its SEC filings.

A few weeks before the announcement, Vaxart granted amendments to the warrants agreements, which allowed Armistice to sell almost all of their stock, which they did once the stock price skyrocketed.

In July, the US Department of Health and Human Services (HHS) told the New York Times that it had not entered into a funding agreement or negotiations with Vaxart. Armistice and HHS did not respond to requests for comment.

Vaxart has not been chosen by Operation Warp Speed to receive research funding, but instead had limited involvement, HHS told the New York Times in July. Vaxart's vaccine, an oral tablet, was only involved in preliminary studies on primates sponsored by Warp Speed.

In a statement to CNN Business Saturday, the company said, "The Vaxart non-human primate challenge study was organized and funded by Operation Warp Speed, as stated in the June 26, 2020 company press release. The statements made in that press release are accurate and any allegation to the contrary is baseless."

In its October SEC filing, Vaxart wrote that it has provided documents called for by the subpoena to demonstrate its role in Operation Warp Speed. "The company has voluntarily provided documents requested by the SEC and is cooperating with this informal inquiry," it stated. 

Vaxart and its board have been sued several times by shareholders who accuse the company of allegedly inflating Vaxart's stock price by misrepresenting its role in Operation Warp Speed. Vaxart addressed those lawsuits in its filing, saying that it's seeking to have two of the suits dismissed, while another class-action suit is still proceeding.

On October 14, Vaxart announced encouraging results from its study on hamsters that received oral dosages of its Covid-19 vaccine.  The stock was down 3.5%, to approximately $6, as of Friday evening.

👺  Clinical Test Failures -  (CNN)   In a study it described as both conclusive and disappointing, the World Health Organization said the antiviral drug remdesivir has “ Little or no effect on mortality” for patients hospitalized with coronavirus and it doesn't seem to help patients recover any faster, either.

Until now, remdesivir has been the only drug that appeared to have specific effects for coronavirus. It was the only drug with an Emergency Use Authorization for Covid-19 from the US Food and Drug Administration.

Results of the WHO study have not been published in a peer-reviewed medical journal. But WHO posted them to a pre-print server.

The WHO study reviewed remdesivir and three other repurposed drugs: hydroxychloroquine, the HIV combination of lopinavir and ritonavir and interferon. None of them helped patients live any longer or get out of the hospital any sooner, WHO said.

The trial was able to generate conclusive evidence on the impact the drugs had on mortality, the need for ventilation, and duration of hospital stay.  "For each drug in the study, the effect on mortality was disappointingly unpromising," WHO said in a statement. 

Several other studies had found that hydroxychloroquine, an anti-malarial drug, was of no benefit to COVID-19 patients, as had several studies looking at the HIV drug combination.  

The study covered more than 11,000 coronavirus patients in 30 countries. "The protocol was designed to involve hundreds of potentially over-stressed hospitals in dozens of countries," the international team of researchers wrote. They said they have submitted their findings to a medical journal.

Prior to the WHO study, a large controlled study of remdesivir in the US found that it shortens recovery time by about a third in severely ill, hospitalized adults with Covid-19, but does little to help those with milder cases.

Gilead Sciences, the drug's maker, said the findings did not mean the drug, sold under the brand name Veklury, is of no benefit.

Hydroxychloroquine didn’t prevent Covid-19 among health care workers in new study.  "The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies published in peer-reviewed journals validating the clinical benefit of Veklury (remdesivir). We are concerned that the data from this open-label global trial have not undergone the rigorous review required to allow for constructive scientific discussion," Gilead said in a statement.

"The benefits of Veklury have been demonstrated in three randomized, controlled clinical trials, including a randomized, double-blind, placebo-controlled clinical trial -- the gold standard for evaluating the efficacy and safety of investigational drugs."

The WHO-led researchers say their trial, called the Solidarity trial, will continue. “ ewer antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies are now being considered for evaluation via the Solidarity Therapeutics trial," WHO said.  Monoclonal antibody treatments include Regeneron's dual antibody cocktail and Eli Lilly and Co's double antibody therapy.

👺  Clinical Test Failures - THIRD COMPANY HALTS TESTING

(CNN) Drugmaker Eli Lilly said Tuesday it is pausing its trial of a combination antibody treatment for COVID-19 for safety reasons.  Usually, clinical trials are paused because a volunteer has suffered a side effect or become ill, but the company did not say what happened.  “Safety is of the (utmost) importance to Lilly," a spokesperson told CNN by email.  It said the trial’s Data Safety Monitoring Board (DSMB), an independent group of medical experts who monitor clinical trials, recommended the pause.  

"The trial, evaluating Lilly's investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study," the company said in the statement.

Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with coronavirus. It is similar to the treatment made by Regeneron that was given to President T-RUMP earlier this month.  The idea behind monoclonal antibody treatments is to give the immune system a head start on fighting the virus. The treatments use antibodies demonstrated to home in on the coronavirus and neutralize it the most effectively. They are infused and patients can have reactions to the infusions.

Drugmaker Johnson & Johnson has paused the advanced clinical trial of its COVID-19 vaccine because of an unexplained illness in a volunteer.  It’s the second Phase 3 COVID-19 vaccine trial to be paused in the US, but experts say it’s not entirely concerning or unexpected for adverse effects, even serious ones, to appear in large studies.  The first Company to quit or stop was AstraZeneca.


ATCH 10-27-2020