January 6 Doesn't Shine a Candle to COVID

March 16, 2023  By Trevor Thomas

With House speaker Kevin McCarthy's release of thousands of hours of Capitol surveillance video footage to Tucker Carlson, and Carlson's subsequent airing of the footage on his popular Fox News show, it's more clear now than ever: what the American left did to Trump, on COVID, on crime (especially the Antifa/BLM riots), at the border, and the like, was far worse than anything that occurred at the U.S. Capitol on January 6, 2021. After Tucker began airing newly released Jan. 6 footage on Tucker Carlson Tonight this past Monday (3/6/23), the next day, Ben Shapiro summarized well what we learned:................ 

 Even after weaponizing the Wuhan Virus and transforming elections throughout the U.S. — which greatly aided the Democrat party in 2020 — leftists continued to push their numerous lies on the Wuhan Virus.  Led by Joe Biden, time and again, American leftists lied about the Wuhan Virus, and their countless allies in media aided and abetted them.

The lockdowns never worked, masks never worked, testing never worked, COVID "protocols" in schools never worked, and the vaccine was far from what was promised.  It is not a stretch to conclude that COVID-19 was "the largest, most sophisticated propaganda operation in history."  The resulting destruction to individual lives, businesses, our economy, our school system, and so on can hardly be quantified.  It was unprecedented destruction, and the Democrat party led the way..............To Read More...

Pandemic of the Vaccinated: New Data from Walgreens Reveals Vaccinated People are More Likely to Test Positive

By Jim Hoft October 16, 2022 532 Comments

According to recent data from over 8,000 Walgreens stores in the United States, the unvaccinated have the lowest incidence of COVID-19, and vaccinated people are more likely to test positive. Indeed, it is the pandemic of the vaccinated. As seen by a 7-day moving average from October 9-15, 2022, the positive rate by vaccination status shows that the unvaccinated group had only 19.5%.

The Positivity Tracker includes Aegis PCR and Rapid NAAT test results at Walgreens stores. Below is the breakdown:...........To Read More....

They Tested Positive! So What?

By Rich Kozlovich 

On April 10th, Bob Cronin, posted this piece, COVID Count After DC Event Reaches 67, third Cabinet member has tested positive.   So, why exactly were they tested?  They tested positive but no one is explaining why they were tested.  We're they sick?  Apparently not, they just tested them anyway.  So if they weren't sick and they tested positive the question everyone should be asking is:  So what? 

And remember, these people have all been shot, and most likely, they've been shot multiple times, and yet they're testing positive.  So what?

First of all these shots aren't vaccinations.  They're treatments.  These treatments don't prevent reinfection and don't prevent transmission, which before now was the standard for something to qualify as a vaccine.  There's growing evidence those who received these treatments are now more susceptible to this virus and it's variants.   It normally takes between ten and twelve years for a drug to come to market, but these treatments came on the market in less that two, and in this case this makes them experimental gene therapy drugs, with consequences we can only guess at. 

There's growing evidence of long term negative effects of these experimental gene altering drugs, and that's what they are.  Normally it takes ten to twelve years for a drug to make it to market, these treatments came to market in less than two.  Beyond the fact they're not legitimate vaccines, this makes them experimental.  There's a reason the CDC had been hiding the VAERS (Vaccination Adverse Event Reporting System) data. 

One comment, or similar thoughts, I see often is:

"90% of hospitalized Covid patients are unvaccinated. That's all you have to know."

Well, that's not all we need to know.  That figure is a logical fallacy because that count started from the beginning of this "pandemic", when there was no treatment of any kind available, and everyone hospitalized was unvaccinated. The fact, that number would be in reverse if you started counting after these treatments became available, and herd immunity started to kick in. Furthermore, this 'pandemic" is no more serious than was the Asian Flu of 57 and 58, and in fact that one was probably more serious, but there's no way of knowing because no one tested then, and in those days they recorded these flu deaths legitimately.  And everyone still went to work.  This is a con on the nation and the world.

Furthermore, that data has been corrupt from the very beginning.   Many of those who were hospitalized didn't come to the hospitals for Covid, they were there because of some other affliction and merely tested positive for Covid.  Not necessarily sick, just tested positive.  From that point on they went on the records as Covid patients. The data claiming Covid deaths included people who actually died from something else, but had the anti-bodies in their system, ergo, they died from Covid, including people who died in a car crash.  All this testing, which has shown to have some substantial reliability problems, is a scam, and has made scientific and medical integrity an oxymoron.

It's my view these experimental drugs being forced on humanity is our Thalidomide era, and the long term consequences, especially to the children, will come back to haunt us for decades. 

If you tested everyone in the nation for all the viruses that's attacked us in the last 75 years you'd find untold numbers who would test positive, and yet perfectly healthy, and these followers of St. Fauci know that and are all part of the "everyone must test" con, tests that have shown a propensity for not being accurate. 

I've been a pro-vaccination guy for all of my life, and defended vaccinations against the anti-vaxxers for years, because the science was on my side.  I'm in the critical category, I'm 75, overweight, out of shape, with a comorbidity.  But I'm not testing, I'm not sick, I will not take the shots, and so what?  The science is still on my side.  

At my age I've seen these viruses come and go. I've seen untold numbers get sick and seen untold numbers die, which happens every year during flu season, except for the last two.  It seems no one died from seasonal flu in the last two years.  Why? 

That's what's happened for all of my life, but now we have tyranny.  I never once saw the world lockdown, mask, social distance, impose treatments on people who didn't want them, never saw alternative treatments be banned by government bureaucrats and I've never before seen people put in concentration camps for refusing to be vaccinated. 

And now I've seen hysteria replace legitimate concern, and that includes many of my (used to be) friends in the scientific community, who once stood for sanity and good science.  But time and truth are on the same side, and now all I reported and stood for the last two years is proving to be true.  Yet St. Fauci and his band of criminals, like all true criminals, will never give up on the con.

Why Is the COVID Case Count So High?

October 11, 2021 By Ted Noel 

The CDC used to define a “case” as a patient whose characteristic signs, symptoms, and physical examination matched a disease. Labs were only done if clinically needed. Since the “pandemic,” however, the move to boost case numbers is everywhere.

Instantly, a “positive” RT-PCR test in an asymptomatic person after a drive-through tonsillectomy became a “case.” The CARES Act gives thousands extra to hospitals for every “positive,” with a big bonus if the patient’s shadow is seen in an ICU. It’s a classic “one hand washes the other scenario” between outside labs and hospitals. “If you give me more positive results, I get more money, so I’ll send more tests to you.”

My hospital’s Medical Staff President flatly denied any CARES Act benefits at our 2020 Medical Staff Extravaganza, but the incentives can’t be denied. My hospital still sends “coders” out to demand that staff order COVID tests to get more payments. Put bluntly, there’s no way to know what any test means medically if the patient isn’t sick. But “positives” definitely mean money!

MIQE standards list eighty-five parameters that must be met in RT-PCR testing. Does every lab meet them all every time? Around the world, celebrities who test “positive” one day and “negative” the next strongly suggest that a lot of mistakes are being made. This is unsurprising since as early as 2017, the technique was well known for “lack of reproducibility.”

The inventor of the test stated that RT-PCR was never intended to be a diagnostic test and using it as one was scientifically illegitimate. “[It’s] like trying to say whether somebody has bad breath by looking at his fingerprint.”

Proper testing requires checking three genetic elements, widely separated in the genome. For CDC counts and CARES Act payments, only two segments get tested, automatically increasing the number of positive tests – by a lot. The lab starts the RT-PCR by doubling genetic material multiple times to make it easier to identify. In research, if it’s not positive by thirty-five “amplification cycles,”, it’s not positive. FDA guidance indicates that anything found up to 40 cycles is considered “positive.” At forty cycles a glass of water may test positive. Stopping at thirty-five would show that COVID-19 wasn’t any worse than flu, if it was that bad................To Read More.....

A Look At COVID-19 Testing

February 1, 2021 By Mike Shaw @ Health News Digest

By Michael D. Shaw

The number of deaths attributed to COVID-19 is astonishing. To be sure, there is an ongoing controversy of how many of these deaths were due to (from) COVID-19 or reflect people who died, happening to also have a COVID-19 infection. An even more basic question is “How do we know when someone is infected with SARS-CoV-2?”

A good starting point to answering that question is the so-called Corman-Drosten paper, entitled “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.” The purpose of the paper was to “develop and deploy robust diagnostic methodology for use in public health laboratory settings without having virus material available.” This work has been used around the world by laboratories as a blueprint to design their own PCR tests and gain Emergency Use Authorization.

However, this paper, touted as “peer-reviewed,” was published less than 24 hours after it was submitted. In fact, a request letter to retract the paper was submitted on November 27, 2020—signed by 22 distinguished scientists. Moreover, an earlier request (October 26, 2020) to provide the peer review report of the Corman-Drosten paper was not answered. The signers of the letter now contend that no peer-review process was ever performed.

The signers also state that “Any molecular biologist familiar with RT-PCR (Reverse transcription polymerase chain reaction—the test being proffered) design would have easily observed the grave errors present in the Corman-Drosten paper before the actual review process.” More that that, two authors of the paper, Christian Drosten and Chantal Reusken, are also members of the editorial board of the publishing journal. Besides being a conflict of interest, the suspicion is created that rapid publication was possible simply because the authors were also part of the editorial board at Eurosurveillance.

The retraction request cites ten “major scientific flaws on the molecular and methodological level.” Quoting from the retraction request letter:

“The first and major issue is that the novel Coronavirus SARS-CoV-2 (in the publication named 2019-nCoV and in February 2020 named SARS-CoV-2 by an international consortium of virus experts) is based on in silico (theoretical) sequences, supplied by a laboratory in China, because at the time neither control material of infectious or inactivated SARS-CoV-2 nor isolated genomic RNA of the virus was available to the authors. To date no validation has been performed by the authorship based on isolated SARS-CoV-2 viruses or full length RNA thereof.”

As further explained here…

The key to developing a successful PCR test is using a master copy of the genetic sequence that is pure and isolated. Any contamination of the master renders the test unreliable. The SARS-CoV-2 master copy, used for PCR testing, was derived from a synthetic RNA strand combined with viral fragments manufactured by Chinese scientists. In other words, scientists made an educated guess at the genetic sequence for SARS-CoV-2. At present, labs continue to use the synthetic virus even though a pure SARS-CoV-2 virus has been isolated.

The “educated guess” includes only two sections of viral RNA, and for this very reason is simply not able to accurately distinguish between SARS-CoV-2, and the many other coronaviruses.

While this article cannot do justice to all the scholarship represented in the retraction request letter, one more key point should be mentioned:

This PCR test contains neither a unique positive control to evaluate its specificity for SARS-CoV-2 nor a negative control to exclude the presence of other coronaviruses, making the test unsuitable as a specific diagnostic tool to identify the SARS-CoV-2 virus.

According to the documentation for the TaqPath™ COVID-19 Combo Kit RT-PCR test (which utilizes the methodology described in the Corman-Drosten paper)…

1. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
2. Negative results do not preclude infection with SARS-CoV-2 virus, and should not be the sole basis of a patient management decision.
3. The assay is for in vitro diagnostic use under the FDA Emergency Use Authorization Only. This test has not been FDA cleared or approved.

All this should raise an alarm; only it probably won’t. I discovered quite long ago that science isn’t so much a search for truth, as it is a search for orthodoxy. After all, what are we now supposed to tell the millions of folks diagnosed using only the PCR test? As to the publishing journal, it is “[S]eeking further expert advice and discussing the current correspondence in detail.”

Funny. I thought that’s what an editorial board does.

Falling pennies and pandemic declarations

October 10, 2020 By Michael Bedar 

 

 Regarding deaths of American citizens in 2020, the departure from the truth about them is fundamentally in the concealing, counting, and recording of numbers. What we've seen in the numbers reporting this year is subject to a timeless trick of deceptive reasoning with statistics and control. 

 

The trick, performed by, let's say, Tricky Tester, first names as "novel" something that almost no one has heard of. Its actual oldness or novelness does not matter. Only the position of being able to control the testing and reporting matters. 

 

Tricky Tester, being in control of the means of testing, conveniently allows no anonymous testing to be added to the reporting. It would be logistically almost impossible to count anonymous tests, anyway. 

 

Therefore, only those who wish to be known by and associated with the institutions doing the testing will then self-select for being tested for it. Without anonymous self-tests, there are no results from people who don't want to be associated with the testing facilities or suffer the possible consequences of doing so (like the well advertised threat of involuntary medical quarantine and isolation, notwithstanding whether the result is accurate or false). The plausible ubiquity of the molecular strand being tested for, then, can never be known...............

 

Pennies fall, and, more sadly, people tumble over the edge of their lives into death. But without the supporting evidence described here, to blame a molecule found in either the person or the penny is a ploy used to rewrite reason, causality, and the scientific method, which logic will not allow. ..........To Read More....

A Look At Mixed Methods Research

September 7, 2020 By Michael D. Shaw @ HealthNewsDigest.COM

In last week’s article, which covered some alternative voices on COVID-19, I said that randomized clinical trials have long been considered the gold standard in determining which drugs to bring to market, even though the sad legacy of failed and withdrawn pharmaceuticals should give one some pause. As former CDC director Tom Frieden noted in 2017:

“Despite their strengths, RCTs have substantial limitations. They can be very expensive to run. They can take many years to complete, and even then may not last long enough to assess the long-term effect of an intervention such as vaccine immunity, or to detect rare or long-term adverse effects. Findings from RCTs may not be valid beyond the study population–a trial that included a high-risk population in order to maximize the possibility of detecting an effect, for example, may not be relevant to a low-risk population. RCTs may not be practical for population-wide interventions and often aren’t relevant for urgent health issues such as infectious disease outbreaks, for which public health decisions must be made quickly.”

He goes on to cite the case of the nasal spray flu vaccine. RCTs suggested that this vaccine was superior to flu shots, at least for some populations. However, later results, from observational studies, showed that the spray was not effective, after all. To put it bluntly, the RCTs were an epic failure. Data from the 2015-2016 season showed that the spray only offered protection 3% of the time, as opposed to 63% with the shot.

Perhaps, the fixation with RCTs stems from the focus of the hard sciences to be, well, “hard.” That is, quantitative analysis of a situation is considered to be superior to qualitative observations. It was William Thomson, aka Lord Kelvin who famously said, in part “[W]hen you can measure what you are speaking about, and express it in numbers, you know something about it; but when you cannot measure it, when you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind.”

Sometimes, though, we forget that the beginnings of nearly all scientific research stem from a simple qualitative observation, for which a hypothesis is formed, and is then tested by experiment. Professor John Creswell lays out the advantages and limitations of quantitative and qualitative research…
Quantitative: Advantages—suitable for large groups; efficient data analysis; people like numbers. Limitations—impersonal, dry; little understanding of context of participants; largely researcher driven.

Qualitative: Advantages—obtain detailed perspectives on fewer people and hear their voices; built from views of participants; people like stories. Limitations—Soft data; smaller groups; highly interpretive; minimizes researcher’s expertise.

As it happens, Creswell is a leading proponent and early adopter of Mixed Methods Research. The term is defined in one of his papers as:

“[A]n emergent methodology of research that advances the systematic integration, or ‘mixing,’ of quantitative and qualitative data within a single investigation or sustained program of inquiry. The basic premise of this methodology is that such integration permits a more complete and synergistic utilization of data than do separate quantitative and qualitative data collection and analysis.”

Mixed methods research originated in the social sciences and over the past few years has expanded into the health sciences. While the detailed techniques are beyond the scope of this article, a paper co-authored by Creswell lists some reasons for using mixed methods in health science…

1. Researchers may seek to view problems from multiple perspectives to enhance and enrich the meaning of a singular perspective. They also may want to contextualize information, to take a macro picture of a system (e.g., a hospital) and add in information about individuals (e.g., working at different levels in the hospital).
2. Merging of quantitative and qualitative data can develop a more complete understanding of a problem.
3. Quantitative and qualitative databases can build on one another. When a quantitative phase follows a qualitative phase, the intent of the investigator may be to develop a survey instrument, an intervention, or a program informed by qualitative findings. When the quantitative phase is followed by the qualitative phase, the intent may be to help determine the best participants with which to follow up or to explain the mechanism behind the quantitative results.

Further reasons for using mixed methods are available in this article, recommended by Creswell.
Imagine how much more we could learn about potential drug side effects, for example, if RCT participants were interviewed in a qualitative, open-ended sense, by a real person–rather than solely replying to a paint-by-numbers checklist as would be provided in a typical quantitative-only study.

Here’s a great qualitative question to be answered by the sponsors of the RCT (the pharmaceutical company): How is this drug any better than the current generic? Excluded answer:

“Because it’s new and proprietary, and we can charge way more for this one.”

The Covid-19 Pandemic is Ending

September 3, 2020 By James G. Robertson

Covid19 has already passed through all 50 states as a single major contagious wave in each state.  There were 33 early states where the epidemic was over by June, and 14 late states where the epidemic now is ending.

Every week in America about 51,000 people die from all causes.  This number rises and falls during the winter due to flu-like illnesses and goes back to baseline in the summer.  No one panics about it, and most people don’t even realize that it happens.  This year was worse than normal, but we’ve almost returned to baseline.

But this year -- everyone panicked!  William Briggs has documented this in his Coronavirus Update series, and this article adds to his analysis by examining state level data.

As Briggs has argued, the most important data is the data for deaths from all causes.  Covid19 attributed deaths are subject to interpretation as either died from or died with Covid19, and death certificates can be misleading because of the attribution of cause (here and here.)  The bubble burst his week when the CDC reported that only 6% of the total Covid19 attributed deaths were from the virus alone..........Briggs also has argued in his Coronavirus Updates that massive public testing has contributed to panic about the virus. Nationally, we are performing about 5 million tests per week......

Nature controls the virus, not the politicians. The ignorant will always be with us, just like the virus. But the virus is not that hard to figure out. Don’t panic. Keep the big picture in mind. Quarantine the sick. Protect the elderly. Let the rest of us free breathing Americans live our lives.........To Read More....

The Big COVID Con Exposed

September 2, 2020 By Brian C. Joondeph, M.D.

One of the great grifter movies, aside from the Clinton and Obama presidencies, is The Sting. Henry Gondorff (Paul Newman) and Johnny Hooker (Robert Redford} team up, “to pull off a complicated scheme known simple as the Big Con,” a racket to crush Doyle Lonnegan (Robert Shaw) and his empire.

We have had several iterations of the Big Con over the past four years, with Gondorff and Hooker played by a rotating cast including James Comey, John Brennan, James Clapper, Joe Biden, Susan Rice, Hillary Clinton, and Barack Obama. All schemed and conspired to destroy Donald Trump and his family and presidency.

The latest sequel features Drs. Anthony Fauci and Deborah Birx as the grifters and swindlers, using the Chinese coronavirus as the Big Con to keep President Trump from winning a second term in the White House. In the movie, the con succeeded but in Washington D.C., the con-verse is happening, with the schemes blowing up in the faces of the deep state grifters..........The new CDC statistics show that only 6,640 deaths are due to COVID alone, rather than the commonly reported 164,280 deaths allegedly associated with COVID. In other words, only 4 percent of media sensationalized deaths were due solely to COVID and not other underlying medical conditions...........To Read More....

The whole scam just fell apart: COVID test, overwhelming number of false positives

By Jon Rappoport —— Bio and Archives--September 1, 2020

“According to The New York Times, potentially 90 percent of those who have tested positive for COVID-19 have such insignificant amounts of the virus present in their bodies that such individuals do not need to isolate nor are they candidates for contact tracing. Leading public health experts are now concerned that overtesting is responsible for misdiagnosing a huge number of people with harmless amounts of the virus in their systems.” (Townhall)..............Let me break this down for you, because it’s a lot worse than the Times admits.  The rabbit hole goes much deeper—-and I’ve been reporting on the deeper facts for months.

The issue appears to be the ballooning sensitivity of the PCR test.  It’s so sensitive that it picks up inconsequential tiny, tiny amounts of virus that couldn’t harm a flea—-and it calls these amounts “positive.”  Therefore, millions of people are labeled “positive/infected” who carry so little virus that no harm would come to them or anyone they come in contact with.........To Read More.....

Oops: It Looks Like the Vast Majority of Positive COVID Results Should Have Been Negative

Bronson Stocking Aug 29, 2020

Testing, testing, testing -- that's how Pelosi and the Democrats say we'll defeat the coronavirus. Meanwhile, President Trump and his administration are conducting "operation warp speed" at breakneck pace to develop therapeutics, diagnostics, and a vaccine for the Wuhan flu. Unlike testing, treatments will actually do something for you when you come down sick with the disease. But now we're learning the overwhelming majority of those who have tested positive for the coronavirus should really have been found negative after all.

According to The New York Times, potentially 90 percent of those who have tested positive for COVID-19 have such insignificant amounts of the virus present in their bodies that such individuals do not need to isolate nor are they candidates for contact tracing. Leading public health experts are now concerned that overtesting is responsible for misdiagnosing a huge number of people with harmless amounts of the virus in their systems..........To Read More....

My Take - This coronavirus is so virulent and so contagious, it takes a test of know if someone has it or not.  Imagine that!

The left’s new hysterical narrative? Testing! Testing? Testing

By Patricia McCarthy April 20, 2020

Having essentially lost the narrative on their “blame Trump” for every death, the Democrats and their media droids have this week settled upon the lack of sufficient testing with which to castigate the President.  They would never call out the bureaucrats of the CDC, which dropped the ball throughout the Obama years, or the NIH, or the NIAID for Fauci’s failures to  be prepared for a pandemic.  No, they have all leapt on the bandwagon to blame Trump for every death, every perceived failure of the federal government to stop a virus unleashed on the world by the actual biggest threat to the world, China............

They all think they will get away with blaming Trump for a lack of testing for a virus no one knew was coming, thanks to China, so there were no tests for it at the snap of anyone’s fingers, least of all Trump who most likely believed that institutions like the WHO, CDC, NIH, Fauci’s crib, NIAID were doing their jobs with the billions of dollars that are doled out to them.

But they were not doing their jobs. They had all succumbed to the whims of the social justice warriors. Race, class and gender topics had superseded the subjects of their research. It is these institutions that were transformed into nothing more than campus grievance organizations during the Obama administration. They had all neglected the primary reasons for their existence and taxpayer funding, most of which has been wasted for years and years. ...............To Read More....

COVID-19 tests: The non-fake news

Our system may not be the fastest, but it’s giving us trustworthy answers

Dvorah Richman

Federal officials recently testified before the U.S. House Committee on Oversight and Reform about government responses to the COVID-19 crisis. Committee members exhibited concern and frustration, and engaged in politicized finger-pointing, over what they said was needlessly slow development and distribution of diagnostic tests – particularly as compared to some other countries.

Some praised South Korea for testing more people in one day than the U.S. did in the past two months. Italy and the U.K. also got positive mention. One wonders whether these Oversight Committee members have any real appreciation for the system that they and their predecessors created. In response to one question, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said “the system is not really geared to what we need right now” and “the idea of anybody getting it easily the way people in other countries are doing it, we are not set up for that.” He added, “that is a failing.”

Committee members and the media seized on this widely misquoted and misinterpreted response as evidence of the government’s failure to provide needed tests. Some background about our system, and facts about the federal government’s actual actions, should correct at least some of the fake news that quickly dominated many articles, editorials and talking head comments.

For reasons rooted in our history, politics and system of government, the United States has myriad federal agencies, with myriad roles and essential healthcare responsibilities. State and local health departments also have critical healthcare roles. A maze of laws, regulations and policies operates at each level. The private sector develops diagnostic tests, obtains Food and Drug Administration (FDA) marketing authorization when required (reflecting the agency’s determination about safety and effectiveness) and then markets the tests for clinical use by medical professionals. While medical professionals generally have discretion in their clinical use of devices and pharmaceuticals, many aspects of the practice of medicine are regulated under state law.

Two federal agencies, the FDA and Centers for Disease Control (CDC), have been front and center in the battle against this novel and deadly virus. Using emergency authority, flexible approaches and “enforcement discretion,” they streamlined many of the normally much more time-consuming processes.

The CDC promotes health, disease prevention and preparedness activities, with the goal of improving public health, in cooperation with state, local and other national entities. During a public health emergency, a primary CDC role is to develop a test for the pathogen and provide state and local public health labs (PHLs) with testing capacity. PHLs focus on the health status of population groups, perform limited diagnostic testing, disease surveillance, emergency response support and other functions.

The FDA is charged with protecting the public health by assuring the safety and effectiveness of various products, including medical device diagnostic tests. FDA reviews and authorizes marketing of such tests, which are designed and manufactured by medical device companies.

Laboratories also develop diagnostic tests. FDA’s authority over tests developed by laboratories (laboratory developed tests or LDTs) has been challenged for many years and, with some exceptions, the agency has exercised “enforcement discretion” in applying laws and regulations to LDTs.

Whatever the avenue, considerable expertise, time and resources on many levels are critical to developing, testing, validating and ultimately getting diagnostic tests that work as intended into the hands of medical professionals.

Considering our many laws, regulations, policies and longtime practices, the CDC and FDA have demonstrated flexibility during this unprecedented healthcare crisis. Congressional testimony noted that CDC scientists developed a diagnostic test for detecting the virus that causes COVID-19 within ten days of China’s disclosure of the genome’s sequence. The test was intended for use by PHLs.

Pursuant to emergency authority under FDA law, FDA issued an Emergency Use Authorization (EUA) to the CDC for its diagnostic test. The CDC began shipping this test to public labs. Shortly thereafter, performance issues unfortunately arose due to a problem in manufacturing one of the reagents. The CDC resolved the issue and began sending corrected tests to public labs. As of March 15, 84 state and local public health labs in all 50 states and the District of Columbia had successfully validated and were using the Center’s COVID-19 diagnostic test.

During this time, the CDC also granted a “right of reference” to performance data contained in its EUA to any entity seeking an EUA for a COVID-19 test, and FDA made templates available for EUA submissions.

On February 29, FDA issued an “immediately in effect” guidance that allowed certain qualified laboratories to use validated COVID-19 tests before FDA had completed its review of their EUAs. That same day, New York’s State Department of Public Health’s (NYSDOH) Wadsworth Center obtained an EUA from FDA for its COVID-19 test. On March 12, FDA used “enforcement discretion” and did not object to NYSDOH’s decision to authorize certain New York laboratories to begin patient testing after validating their tests and notifying the NYSDOH.

FDA has engaged with many test developers working on this issue. It issued its first EUA for commercial distribution of a COVID-19 test to Roche Molecular Systems on March 12. Since then, other medical device companies have received EUAs for their COVID-19 diagnostic tests. Labcorp, Quest and other commercial, healthcare system and academic labs are also providing patient tests.

On March 16, FDA issued revised guidance providing additional flexibility for states to authorize laboratory tests developed by qualified in-state labs for use in their states. Five days later, FDA granted the first EUA for a test that will provide results in hours, without having to go to a lab.

House Committee members asked why the United States cannot just use tests developed by South Korea, other countries or the World Health Organization (WHO). The simple answer is that federal laws and regulations require that medical devices (including diagnostic tests) must undergo FDA review and obtain approval or clearance before they can be marketed in the United States, unless that particular type of device is exempt. This applies to medical devices developed in the USA, and to those developed elsewhere. On the laboratory side, diagnostic tests (whether or not they receive FDA review and authorization) are also subject to scrutiny.

This process is intended to ensure that diagnostic tests work as intended, without false negatives that would put sick people back on the streets to infect others – or false positives that indicate healthy people are sick and thus use healthcare resources meant for those who are ill. While FDA Commissioner Stephen Hahn was reluctant to criticize other countries, he did note during a March 7 White House briefing that several countries have had “different levels of success” with their diagnostic tests and one unspecified country had “problems with the performance of several tests.”

The private sector is ramping up, and tests for COVID-19 are available in larger quantities. Ironically, some critics are now saying the federal government’s actions regarding diagnostic tests have been too flexible. Other test-related issues are emerging, including possible shortages of important chemicals, equipment availability and the capacity of U.S. labs to handle needed testing.

Our healthcare system has many moving parts, with critical, interfacing roles for government and the private sector. The system is already unleashing the creative powers of federal, state, local, university and private sector experts and innovators, who will develop, test and deploy diagnostic, preventive, therapeutic and curative technologies to tackle COVID-19. This is the American way.

When the dust settles, there will be time to assess problems and identify solutions, perhaps including new legislation, to address future crises. In the meantime, our various moving parts need to work collaboratively to address all aspects of this crisis – while maintaining, where feasible, a flexible approach in applying laws, regulations and policies that were not really designed to handle the monumental crisis at hand.

Ms. Richman served as in-house and outside regulatory counsel to FDA-regulated companies for over 35 years. Her work has focused on FDA laws, regulations and policies, primarily regarding medical devices and related regulatory and compliance matters. Her most recent position was VP, Chief Regulatory Counsel to Siemens Healthineers.

Continuing Saga: EPA and Unlawful Human Testing

North Carolina Medical Board Opens Investigation of Another EPA Doc

We were notified yesterday by the North Carolina Medical Board that it has opened an investigation (at our request) into another North Carolina-licensed physician involved in EPA’s illegal human testing.

EPA comments on human testing lawsuit; Claims UNC is ‘independent’; Records show otherwise

In response to yesterday’s Washington Times report by Kerry Picket (“Lawsuit filed against EPA over pollution experiments on humans“), the EPA e-mailed Picket:

###