Ending the Pandemic 1 - CDC's Deadly Testing Fiasco

UNBREAKING SCIENCE
with Dr. James Lyons-Weiler
ENDING THE PANDEMIC, PART 1
CDC’S DEADLY TESTING
FIASCO

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USA - DAYS SINCE FIRST CASE
https://www.worldometers.info/coronavirus/Data source:
Confirmed
Cases

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Days Since First Case
Estimated Undetected + Detected

FLU (A+B)
vs.
COVID-19
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Influenza (Real) vs. COVID19 (Estimated)
Flu (A+B) COVID19 COVID19*6
Influenza A+B (real)
COVID19 (real)
COVID19 (real + 86% not detected
https://www.cdc.gov/flu/weekly/weeklyarchives2019-2020/data/whoAllregt_cl11.html
https://science.sciencemag.org/content/early/2020/03/13/science.abb322186% Undetected Source

MEDICAL RESOURCES - US
Resource Available Moderate Severe
HOSPITAL BEDS 920,000 1,000,000 9.6M
INTENSIVE CARE UNITS 68,000 200,000 2.9M
VENTILATORS 168,900 740,000
http://www.centerforhealthsecurity.org/cbn/2020/cbnreport-02272020.html

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Days Since First Case
COVID-19
Estimated Undetected + Detected
3/24/2020

2. CDC DECLINED WHO’S TEST FROM GERMANY
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988269/

Germany Test
Validated
Jan 17, 2020

3. CDC WANTED THEIR “OWN” TEST
POLITICO EXCERPT
Reading from Politico

Dr. Nancy Messonier • Reading from CDC

Anthony Fauci’s
Non-Explanations
• “[It]was a technical
glitch that slowed
things down in the
beginning. Nobody’s
fault. There wasn’t
any bad guys there. It
just happened.”

• Q: Big picture: We’ve had all this pandemic preparedness.
Why did this fail? What went wrong?
• AF: I think we’ll have to wait until it is over and we look back
before we can answer that. It’s almost like the fog of war.
After the war is over, you then look back and say, “Wow, this
plan, as great as it was, didn’t quite work once they started
throwing hand grenades at us.” It really is similar to that.
Obviously, testing [for the new coronavirus] is one clear issue
that needs to be relooked at. Why were we not able to
mobilize on a broader scale? But I don’t think we can do that
right now. I think it’s premature. We really need to look
forward.

Hugh Hewitt – 3/17/20
• AF: You know, it was a complicated series of multiple things that conflated that just, you know,
went the wrong way. One of them was a technical glitch that slowed things down in the
beginning. Nobody’s fault. There wasn’t any bad guys there. It just happened. And then when we
realized, when the CDC realized, and the FDA said both the system itself as it was set up, which
serves certain circumstances very well, was not well-suited to the kind of broad testing that we
needed the private sector to get involved in. The regulatory constraints, which under certain
circumstances are helpful and protective of the American people were not suited to the
emergence of this particular outbreak. So there was a confluence of a bunch of things. I believe
now that the CDC and the FDA and the Department, that we’ve got it right now, because we’re
handing much of it over to the private sector to heavy hitter companies that do this for a living.
And I think what you’re going to be seeing looking forward is a major, major improvement in the
availability of testing.
• HH: Was the glitch or anything about the production of the test President Trump’s fault? Or
actually, let me put it more broadly, would every president have run into the same problem?
• AF: Oh, absolutely. This has nothing to do with anybody’s fault, certainly not the President’s fault.

4.
Whistleblower:
CDC LIED TO
THE
PRESIDENT

Chris Meekin
Former Assistant Secretary, HHS
Reading from Sinclair Investigative Reporting
Rosen Interview of Chris Meekin

5. What Was Wrong w/CDC’s Test?
• Specimen mislabeled
• “Flawed component” –
• One of three genes did not amplify
• RNA Extraction Kit limiting factor
• CDC Wanted to Market a Test that Testing SARS, MERS and SARS-CoV-
2 – COMPLICATED?
• Insufficient numbers of tests
• FALSE NEGATIVES

“Not Enough Tests”
So Triage

Reports on Testing -
Transcript -
• Reporter: You talk about the case count being low, how do
we reconcile that with the fact that here in California the
most populous state, the governor yesterday said only a
couple hundred testing kits. The case count will be low
because it sounds like there is not enough tests that could
reflect it. It seems like the issue the math on that seems to
be a low count.
• Dr. Messonnier: Yes, thank you for the opportunity to talk
about that. We need to remember that this situation is taken
place rapidly. By far the majority of cases have been in
California. A few weeks ago we found an increase in cases
around the world. And again this week we have seen an
increase in cases globally. Because of the aggressive U.S.
efforts at our border strategy the number of cases have been
low. And we have been able to focus our efforts on travelers
and their close contact based on our evaluation of who is at
highest risk. We will continue to modify our approach. In
terms of diagnostic testing, additional labs are coming on-line
and additional test kits are on their way now.

Next question…
• Operator: Our next question comes from Michelle Cortez, at Bloomberg News, your line
is now open.
• Michelle Cortez: I think what a lot of us are grappling with a little bit is the idea that
China has been able to do tens of thousands of tests. Korea has been able to do
thousands of tests. And here in the US, in our local we have done about 500 in our local
patients and then plus another 2,000 patients or so that have been repatriated — we
just don’t have the numbers they do. Can you explain that to us how others aer able to
do thousands and thousands of tests, that we have not been able to do that yet?
• Dr. Messonnier: I think there are two answers to that question. One is that the
epidemiological situation in China and other countries is really different from the U.S.
We acted incredibly quickly before most other countries. Aggressively controlled our
borders and we were able to slow the spread into the United States. That was an
intentional US strategy with the goal of allowing us to control our efforts, so we have
focused surveillance for those at highest risk. And again, that is why the number of
patients that were identified as PUIs in the US has been smaller. I guess i would also
direct you back, the CDC role was in rapidly developing a diagnostic and focusing on the
front line on getting that out to the public. But our solution, a larger part of the any
such infectious disease is getting the test kit out more broadly to the hospitals, and to
the HHS and to the front lines, and that is part of a U.S. government strategy that is a
huge priority with HHS leadership right now. CDC has always had the capacity to test
from the time rapidly when the sequence was available and that is two labs at the CDC
doing the testing, and we have been testing aggressively the patients that state health
departments have referred to us.

2/29 FDA RELENTS,
ALLOWS LOCAL
LABS TO DEVELOP
TESTS

South Korea
https://virusncov.com/

CDC Website – 3/23/2020
• The U.S. Secretary of Health and Human Services declared the SARS-
CoV-2 virus a U.S. public health emergency on Friday, January 31,
2020. FDA issued the EUA on February 4, 2020. IRR began distribution
of the test kits to states, but shortly thereafter performance issues
were identified related to a problem in the manufacturing of one of
the reagents which led to laboratories not being able to verify the test
performance. CDC is remanufacturing the reagents with more robust
quality control measures. New tests will be distributed once this
issue has been addressed. CDC continues to perform initial and
confirmatory testing.

6. CDC is Not
Ready for ANY
Major Outbreak

Health Freedom
Activists
“In fact, when we actually check the data, we learn
that people whose deaths were reported as
"influenza deaths" were not lab-confirmed as even
having HAD influenza, let alone having died from
influenza. All final death numbers in the
CDC's National Vital Statistics Reports' Final Death
Data, up until 2016, always separated influenza
deaths from pneumonia deaths (for darned good
reasons: most people who have pneumonia do NOT
also have influenza!).”

Test Principle
• BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is
immunochromatography based. The test card contains (1) colloidal gold-labeled
recombinant novel coronavirus antigen and quality control antibody colloidal gold
marker, two detection lines (G and M lines) and one quality control line (C) fixed on a
nitrocellulose membrane. M is fixed with monoclonal anti-human IgM antibody for
detecting the novel coronavirus IgM antibody. G is fixed with monoclonal antihuman IgG
antibody for detecting the novel coronavirus IgG antibody. The quality control antibody is
fixed on the C line. When an appropriate amount of test sample is added to the sample
well of the test cassette, the sample will move forward along the test card via capillary
action. If the sample contains IgM antibody, the antibody will bind to the colloidal gold-
labeled novel coronavirus antigen. The antibody/antigen complex will be captured by the
anti-human IgM antibody immobilized on the membrane, forming a red M line and
indicating a positive result for the IgM antibody. If the sample contains IgG antibodies,
the antibody will bind to the colloidal gold-labeled novel coronavirus antigen and the
antibody/antigen complex will be captured by the antibody immobilized on the
membrane, forming a red G line and indicating a positive result for the IgG antibody. If
neither antibody is present, a negative result is displayed.

Performance Evaluation Data - Biomedomics
• In order to test the detection sensitivity and specificity of the COVID-
19 IgG-IgM combined antibody test, blood samples were collected
from COVID-19 patients from multiple hospitals and Chinese CDC
laboratories. The tests were done separately at each site. A total of
525 cases were tested: 397 (positive) clinically confirmed (including
PCR test) SARS-CoV-2-infected patients and 128 non- SARS-CoV-2-
infected patients (128 negative). The testing results of vein blood
without viral inactivation were summarized in the Table 1. Of the 397
blood sample from SARS-CoV-2-infected patients, 352 tested positive,
resulting in a sensitivity of 88.66%. Twelve of the blood samples from
the 128 non-SARS-CoV-2 infection patients tested positive, generating
a specificity of 90.63%.

Performance
Evaluation
Data - CDC
“ As more cases have been identified and more
cases have been available it is clear that two of
the three reactions, we actually are appropriately
sensitive and specific in identifying cases. ”
Dr. Messonier
Friday, February 28, 2020
https://www.cdc.gov/media/releases/2020/t0228
-COVID-19-update.html

Further from the transcript (Dr. Messonier)
• Right now, labs can start testing with existing CDC test kits. States that were able to
validate their kits should continue to test in this manner. States that were able to validate
only the two components specific to novel coronavirus can test using only these two
using revised instructions developed at CDC. We have established that the third
component, which was the cause of the inconclusive results, can be excluded from
testing without affecting accuracy. We have been working with FDA and they agree with
our approach. While we’re working to amend the existing EUA, we have discretionary
authority from FDA to proceed in this manner. This will increase testing capacity at state
and local health departments. All positive test results will continue to be confirmed by
CDC for some time.
• Additionally, CDC has manufactured brand new test kits that will only include the two
components that are specific to novel coronavirus. Those test kits are at the
International Reagent Resource, where orders can be placed. We are working as quickly
as we can to get CDC test kits to state and local public health authorities. However,
during any infectious disease response there is a great need for test manufacturers to
rapidly make testing available in clinics, in hospitals, and at the bedside. This is part of
a huge effort within the US government led by HHS.

March 16
FDA Relaxed
Restrictions on
Non-CDC testing

NOT A PAID
ENDORSEMENT
NO QUID
PRO QUO
FIND OUT
MORE

290,000 tests
“>90% Negative”
How many False
Negatives?

CDC
Wanted
Their
“Own”
Test

IPAK Statement 3/24/2020
• The current situation in terms of the exponential increase in the number of cases of COVID-19 and deaths from this
infection, the lost opportunity for the medical community to be ready, school closures, the isolation-in-place, the loss of
income, general disruption of how our society functions, and the awesome losses in the private sector were all utterly
avoidable and can be traced directly to the Center for Disease Control’s decision – which it continues to make – to refuse
to adopt an already validated test from Germany.
• The fact that the public and the medical community alike have even now not been told the exact nature of the flaw, or
flaws, in CDC’s test, is profoundly unacceptable.
• We are deeply concerned that false negatives continue to drive the rate of spread of SARS-CoV-2 in the United States.
• We urges all laboratories to use validated, non-CDC test kits.
• These events demonstrate that the centralization of risk detection, surveillance, modeling, diagnostic testing and public
health policy in one location, with one culture, and limited human resources places US national security at Risk.
• These events have proven CDC to be unskilled, unresponsive, redundant and, in reality, a dire threat to public health
during a pandemic in which accuracy and timeliness of responsiveness is critical.
• Major US Universities and Hospital Systems all house talents in diagnostics that are vastly superior – and that are also, by
definition more diverse. Decentralization of public health responsibilities is highly recommended.
• For reasons related to national security, CDC should no longer promote its test, nor should it serve as a centralized
“validation” center for testing for infectious diseases.
• Those involved in the decision to refuse the validated test from Germany should resign. Those who have misinformed the
public and Secretary Azar, and thereby the President of the United States, should resign.

Hotez
• “I understand the importance of accelerating timelines for vaccines in general, but from
everything I know, this is not the vaccine to be doing it with,” Dr Peter Hotez, dean of the National
School of Tropical Medicine at Baylor College of Medicine, told Reuters.
• Hotez worked on development of a vaccine for SARS (Severe Acute Respiratory Syndrome), the
coronavirus behind a major 2003 outbreak, and found that some vaccinated animals developed
more severe disease compared with unvaccinated animals when they were exposed to the virus.
• “There is a risk of immune enhancement,” said Hotez. “The way you reduce that risk is first you
show it does not occur in laboratory animals.”
• Hotez testified last week before the U.S. House Committee on Science, Space and Technology
about the need for sustained funding for vaccine research. There remains no vaccine for any of
the new coronaviruses that have caused outbreaks in the past 20 years.
• Hotez said he was surprised human trials were going ahead. “If there is immune enhancement in
laboratory animals vaccinated with the Moderna vaccine, that’s a showstopper,” he said.

J&J on Pathogenic Priming
• “People know how traumatic the RSV experience was,” said Dr Johan
Van Hoof, global head of Janssen Vaccines, J&J’s vaccine unit. “When
you see signals in animals like this, we should not ignore them.”

WHO Held a Closed Meeting Not Open to the
Public or to the Media
• “You want to have a vaccine as quickly as possible,” Dr Marie-Paule
Kieny, former assistant director-general at the WHO, who co-chaired
the meeting, told Reuters. “You have to balance this with the risk that
you impose on a very small number of people, and do all you can do
to mitigate this risk as much as possible.”
• Testing for the specific risk of vaccine enhancement in animals will
proceed simultaneously with human trials, the NIH told Reuters,
which it said should establish whether it is safe to expose larger
numbers of people to the vaccine. Moderna did not respond to
requests for comment.

Ending the Pandemic 1 - CDC's Deadly Testing Fiasco

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