Publisher’s Note: This new article by Tom Cowan, MD, explains why “testing” for COVID-19 is “utter nonsense.” “Literally, “non sense,” as in “makes no sense.” Some Vermonters might find this title frustrating, as we’ve heard so much about testing in the past few weeks here in our once and future Republic of Vermont. Cowan helps clarify the problems with testing, and why testing is “nonsense.” Here’s Cowan: “I want to be clear about this point: This confusion is not a matter of ‘we need to improve the tests’ or ‘we need to understand the immune system, virus, mutations, etc., better,’ Cowan writes. ‘This circumstance is a failure of the very concept of surrogate testing, which is what’s being used with Covid-19.’ As Vermonters talk more about “testing” for COVID, this article may be helpful. We’ve covered the problems with testing in part 2 of COVID EMPIRE, but Cowan states it so clearly here, we felt this worth sharing for our Green Mountain communities. “With Covid-19 testing, the gold-standard test has never been done,” Cowan concludes. “Therefore, it’s impossible to know how accurate the test is.” Meanwhile, Dr, Sherry TenPenny weighs in below with her detailed concerns re: testing, and here’s a handy chart on WHY a “PCR Test” cannot be used to indicate the presence of ANY active infections or viruses, as indeed, the INVENTOR of the PCR test, scientist Kary Mullis, warned us three decades ago. (See part 2 of COVID EMPIRE.)
Imagine your refrigerator breaks down, and you go to a respected appliance store to find a replacement. You see a new model of a ‘fridge you have had your eyes on and ask the salesperson what he thinks of this particular model. “Yes, it’s the newer model,” he says. “It is possible it can keep the food cold, but it’s also possible it won’t keep the food cold.”
At that point, you might not only question whether you want to buy that fridge, but also how you got dropped into the middle of an Alice in Wonderland performance.
This past Sunday in our local newspaper, the San Francisco Chronicle, the lead story was titled “Antibody Test Hopes, Doubts.” Here are two quotes from the article. The first is a “disclaimer” from the FDA required on all the new Coronavirus antibody tests: “Negative tests do not rule out SARS-CoV-2 and positive results may be false.”
In other words, the fridge might work or it might not.
Also quoted was Marin County’s public health officer. He said, “I tell them you will likely be negative” if tested. “And it either means you were not infected or you were and it’s wrong.”
So, the test either means you were infected or you weren’t infected, which I guess covers all the bases.
I want to be clear about this point: This confusion is not a matter of “we need to improve the tests” or “we need to understand the immune system, virus, mutations, etc., better.”
This circumstance is a failure of the very concept of surrogate testing, which is what’s being used with Covid-19. You simply can’t use a surrogate test EVER for diagnosis unless you have a definitive (called “gold standard”) test to compare it to.
I have addressed this topic many times during this crisis, but I’ll try again to be as clear as I can about the requirements for an accurate surrogate test.
Take the example of the testing to diagnose a pulmonary embolism, otherwise known as a blood clot in an artery to the lung. In a patient with chest pain and suspicion of a clot in one of the arteries in a lung, one can do an angiogram, in which dye is injected into the artery. If a clot is present, the dye will show the presence of this clot 100 percent of the time. This test becomes the gold standard, meaning, you can use it to detect the presence or absence of a clot with 100 percent certainty. You can then test a surrogate examination called a V/Q scan against the angiogram results. The V/Q scan looks at the perfusion or flow of the blood into the lung (this is a somewhat simplistic explanation but it demonstrates the point). A clot will affect the flow of blood.
Here’s how it works.
If you take 100 patients who have a blood clot present on angiogram, you can determine the number of patients who have a positive V/Q scan. If 99 out of the 100 proven patients with a clot have a positive V/Q scan, then you know with certainty that the false negative rate is 1 percent. At that point, the doctor can forgo the more expensive and dangerous angiogram and use the V/Q scan, knowing it will pick up 99 percent of the positives.
The next step is to do the V/Q scan on 100 patients with chest pain whose angiogram is normal, meaning, you are certain they have no blood clots. If the positive rate is 2 out of 100, then you know with certainty that the false positive rate is 2 percent. Again, this allows you from then on to forgo the angiogram and do only the V/Q scan on people with characteristic signs and symptoms of a pulmonary embolism because you know for certain the error rate of the test.
With Covid-19 testing, the gold-standard test has never been done. Therefore, it’s impossible to know how accurate the test is. The only conclusion that any rational person can draw is that the entire testing for Covid-19 is completely unstandardized and therefore meaningless. What happens in a situation like this is you get reports of wildly divergent false-positive and false-negative rates.
In addition, I’m frequently asked about antibody tests, as in, “doesn’t having antibodies mean you are immune to the Coronavirus and therefore must have had an infection at some point?” According to the Marin public health director, it turns out we have no clue what an antibody test means. Years ago, we were taught antibodies meant you were immune and therefore safe. Then they came out with HIV tests and found antibodies and told us that meant you had the disease. Then they said that sometimes having antibodies meant you were immune, sometimes it meant you had the disease, and sometimes it meant nothing. Antibody tests are another surrogate test that means nothing and can never be improved to mean something.
The whole thing is a house of cards.
To finish this point, I was interested to read recently that the president of Tanzania was skeptical of the testing. He decided to test a goat, a sheep and a paw paw fruit to see what happened. He gave the samples names and dates of birth and sent them in to be analyzed. The goat and the piece of fruit tested positive. I hope this doesn’t trigger the FDA to ban goat-milk products and paw paws. But now that we live in Alice’s world, anything is possible.
Stay well and keep questioning.
SNIP
COVID-19 TESTING: WHAT ARE WE DOING? WHAT DOES IT MEAN?
by Dr. Sherri Tenpenny, DO, AOBNMM, ABIHM
In 1965, scientists identified the first human coronavirus; it was associated with the common cold. The Coronavirus family, named for their crown-like appearance, currently includes 36 viruses. Within that group, there are 4 common viruses that have been causing infection in humans for more than sixty years. In addition, three pandemic coronaviruses that can infect humans: SARS, MERS, and now, SARS-CoV-2.
As the news of deaths in China, South Korea, Italy, and Iran began to saturate every form of media 24/7, we became familiar with a new term: COVID-19. To be clear, the name of the newly identified coronavirus is SARS-CoV-2, short for Severe Acute Respiratory Syndrome Coronavirus-2. This virus is associated with fever, cough, chest pain, and shortness of breath, the complex of symptoms that form the diagnosis of COVID-19.
The Trump administration declared a public health emergency on January 31, 2020, then on February 2 placed a ban on the entry of most travelers who had recently been in China. On February 4, Alex Azar, the Secretary of Health and Human Services (HHS) issued a declaration of public health emergency and activated the Public Readiness and Emergency Preparedness Act, otherwise known as the PREP Act. This nefarious legislation provides complete protection of manufacturers from liability for all products, technologies, biologics, or any vaccine developed as a medical countermeasure against COVID-19. For those nervously waiting for the vaccine to become available, be sure to understand the PREP Act before rushing to the get in line.
Calls for testing – to see if a person is or isn’t infected – began soon after the emergency was declared, but performing those tests was initially slow due to an inadequate number of test kits. As the kits became available, those developed by the CDC had a defect: The reagents reacted to the negative control sample, making the test inaccurate and the kits unusable.
In various countries, thousands of test kits purchased from China were found to be contaminated with the SARS-CoV-2 viruses. No one really knows how that happened, but theories spread like wildfire. Could the test kit infect the person being tested? Or, did it mean the test would return a false-positive result, driving up the numbers of those said to be infected so those in power could implement stronger lockdowns and accelerate the hockey-stick unemployment rates? Neither of those questions has been adequately answered.
Authorities claim that testing is important for public health officials to assess if their mitigation efforts – “shelter in place” and “social distancing” and “wearing a mask” – are making a difference to “flatten the curve.” Officials also claim that testing is necessary to know how many persons are infected within a community and to understand the nature of how coronaviruses spread.
Are these reasons sufficient to give up our health freedom and our personal rights, being tested and shamed in public?
Despite the challenges with test kits, testing began. By the end of March 2020, more than 1 million people had been tested across the US. By May 9, the number tested had grown to over 8.7M. Testing methods include a swab of the nasal passages or by inserting a long, uncomfortable swab through the nose to scrape the back of the throat. Specimens have also been obtained bronchoalveolar lavage, from sputum, and from stool specimens.
The call for mandatory testing has been gathering steam and becoming ever more onerous. In Washington state, Governor Inslee has declared:
Individuals that refuse to cooperate with contact tracers and/or refuse testing, those individuals will not be allowed to leave their homes to purchase basic necessities such as groceries and/or prescriptions. Those persons will need to make arrangements through friends, family, or state provided ‘family support’ personnel.
But what do the results really mean?
On May 8, 2020, the CDC has listed specific priorities for when testing should be done. As of May 16, more than 11-million samples have been collected and more than 3700 specimens have not yet been evaluated.
High Priority
Priority
Read that last priority again: That means virtually everyone can be required to get a test.
Is that a violation of your personal rights? And, if you submit to testing, what does a “positive test” actually mean?
PCR, short for polymerase chain reaction, is a highly specific laboratory technique. The key to understanding PCR testing is that PCR can identify an individual specific virus within a viral family.
However, a PCR test can only be used to identify DNA viruses; the SARS-CoV2 virus is an RNA virus. Therefore, multiple steps must be taken to “magnify” the amount of genetic material in the specimen. Researchers used a method called RT-PCR, reverse transcription-polymerase chain reaction, to specifically identify the SARS-CoV-2 virus. It’s a complicated process. To read more about it, go here and here.
If a nasal or a blood sample contains a tiny snip of RNA from the SARS-CoV-2 virus, RT-PCR can identify it, leading to a high probability that the person has been exposed to the SARS-CoV-2 virus.
However – and this is important – a positive RT-PCR test result does not necessarily indicate a full virus is present. The virus must be fully intact to be transmitted and cause illness.
Even if a person has had all the symptoms associated with a coronavirus infection or has been closely exposed to persons who have been diagnosed with COVID-19, the probability of a RT-PCR test being positive decreases with the number of days past the onset of symptoms.
According to a study done by Paul Wikramaratna and others:
In other words, the longer the time frame between the onset of symptoms and the time a person is tested, the more likely the test will be negative.
Repeat testing of persons who have a negative test may (eventually) confirm the presence of viral RNA, but this is impractical. Additionally, repeated testing of the same person can lead to even more confusing results: The test may go from negative, to positive, then back to negative again as the immune system clears out the coronavirus infection and moves to recovery.
And what makes this testing even more confusing is that the FDA admits that “The detection of viral RNA by RT-PCR does not necessarily equate with an infectious virus.”
Let’s break that down:
You’ve had all the symptoms of COVID19, but your RT-PCR test for SARS-CoV-2 is negative.
So, what does a “positive” test actually mean? And that’s the problem:
No one knows for sure.
According to the nonprofit Foundation for Innovative New Diagnostics (FIND), more than 200 serologic blood tests, to test for antibodies, are either now available or in development.
There are two primary types of antibodies that are assessed for nearly any type of infection: IgM and IgG. While several new testing devices are being touted as a home test, they are not the same as a home pregnancy test or a glucometer to you’re your blood sugar. The blood spot or saliva specimen can be collected at home, must it must then be sent to a laboratory for analysis. It can take a few days – or longer – to get the results. With so many tests in the pipeline, the ability to test at home will be changing over time.
The first antibody to rise is IgM. It rises quickly after the onset of the infection and is usually a sign of an acute, or current, infection. The IgM levels diminish quickly as the infection resolves. The FDA admits they do not know how long the IgM remains present for SARS-CoV-2 as the infection is being cleared.
The interpretation of an IgG antibody is more difficult. This antibody is an indicator of a past infection. The test is often not specific enough to determine if the past infection was caused by the SARS-CoV-2 virus or one of the four common coronaviruses that cause influenza-like illness.
The FDA says:
Because serology testing can yield a negative test result even if the patient is actively infected (e.g., the body has not yet developed in response to the virus) or maybe falsely positive (e.g., if the antibody indicates a past infection by a different coronavirus), this type of testing should not be used to diagnose an acute or active COVID-19 infection.
Similarly, the CDC says the following regarding antibody testing:
What? Wait!
If the FDA does not know if an IgG antibody to SARS-CoV-2 after recovering from the infection is protective against a future infection, then they certainly don’t know if an antibody caused by a vaccine will prevent infection either.
Doesn’t this completely eliminate the theory that antibodies afford protection and antibodies from vaccines are necessary to keep you from getting sick?
Illinois U.S. Rep. Bobby L. Rush introduced the H.R. 6666 TRACE Act on May 1. On his website, Rush said,
Until we have a vaccine to defeat this dreaded disease, contact tracing in order to understand the full breadth and depth of the spread of this virus is the only way we will be able to get out from under this.
H.R.6666 would authorize the Secretary of Health and Human Services (HHS), acting through the Director of the CDC to award grants to eligible entities to conduct diagnostic testing and then to trace and monitor the contacts of infected individuals. The contact tracers would be authorized to test people in their homes and as necessary, quarantine people in place.
Where do they intend to do this testing? Besides mobile units to test people in their homes, the bill identifies eight specific locations where the testing and contract tracing could occur: schools, health clinics, universities, churches, and “any other type of entity” the secretary of HHS wants to use.
The bill would allocate $100 billion in 2020 “and such sums as may be necessary for fiscal year 2021 and any subsequent fiscal year during which the emergency period continues.”
But what are they looking for?
The virus is rapidly mutating, which is rather typical of RNA viruses. In a study published in April 2020, researchers have discovered that the novel coronavirus has mutated into at least 30 different genetic variations. If your RT-PCR test is positive, does this identify exposure to the pandemic virus or exposure to one of the genetic variations? The same can be said about the vaccines under development: With each mutation, is the vaccine more likely to be all risk and no benefit when it reaches the market?
Across the nation, police are being told to not apprehend criminals but instead, to arrest parents at playgrounds, to arrest lone surfers on public beaches, to fine ministers and congregation members sitting in their cars listening to a service on the radio, and to restrict movement by creating one-way sidewalks.
People have had enough. They are beginning to see the huge scam that has been perpetrated on the entire world over a viral infection with a global death rate of 1.4% (meaning, 1.4% of people infected with SARS-CoV-2 have a fatal outcome, while 98.6% recover). This is far fewer deaths than a severe flu season.
We’re already starting to see the thrust to take our power back:
While they shut us down and held us hostage in our homes, they changed our society, our lives, our world. I am not willing to accept this is the “new normal.”
It’s time for Americans to resist with non-violent civil disobedience. Be brave. Be bold. Put on the full armor of God, as found in Ephesians 6:10-20 in the Bible, to stand against the world rulers of this present darkness. With God on our side, all things are possible.