Useless FDA and CDC admit Covid antibody tests are worthless. Why have they approved them? Why are we paying for them?

I have been meaning to update the information on Covid-19 testing, since it has been such a confusing subject. This post will only cover antibody (aka serology) tests.  And most of the post will be direct quotes from the FDA and CDC websites, because you would probably not believe me if I simply paraphrased the information.  So here is my synthesis, followed by direct quotes from the agencies.

Boiled down, what FDA and CDC say is: 

1.   The presence of antibodies does not mean you have had Covid.  

2.   The test might be positive due to a cross reaction with antibodies from a cold you had.  

3.   Even if you have antibodies and did have Covid, they don't tell us whether or not you are immune.

4.   Even if you are immune today, you may not be immune tomorrow--who knows?

5.   You may have had Covid and have no antibodies

6.   Antibody tests are meaningless for individuals, but might give us useful information at the population level.

7.   Regardless of the result, you still need to wear masks and socially distance.

8.   In a population where less than 5% have had Covid, over 50% of positive results will be false positives.

Yet CDC admits that reinfection is rare.  There are only 3 documented cases of reinfection in the US, so there must be good immunity after infection for most people.  

Bottom line:  why are we doing these tests?  Why hasn't FDA rescinded its emergency approval, since in the majority of the US, most positive results are false positives? And why don't we have better tests? T-cell immunity is probably more accurate, but there are no commercially available T-cell tests for the public. Why are we still measuring antibodies that cross-react with those for the common cold?  Is this another way the federal government is keeping us confused and locked down?

Here are the direct quotes:

FDA:  

"...COVID-19 antibody tests can help identify people who may have been infected with the SARS-CoV-2 virus or have recovered from the COVID-19 infection." 

At this time, researchers do not know whether the presence of antibodies means that you are immune to the coronavirus in the future; or if you are immune, how long it will last."

CDC:  

"...additional data are needed before modifying public health recommendations based on serologic [antibody] test results, including decisions on discontinuing physical distancing and using personal protective equipment. 

...Although serologic tests should not be used at this time to determine if an individual is immune, these tests can help determine the proportion of a population previously infected with SARS-CoV-2

...Recurrence of COVID-19 illness appears to be very uncommon

...However, it remains uncertain to what degree and for how long individuals with antibodies (neutralizing or total) are protected against reinfection with SARS-CoV-2 

...in a population where the prevalence is 5%, a test with 90% sensitivity and 95% specificity will yield a positive predictive value of 49%. In other words, less than half of those testing positive will truly have antibodies. 

...pending additional data, the presence of antibodies cannot be equated with an individual’s immunity from SARS-CoV-2 infection.

...Some tests may exhibit cross-reactivity with other coronaviruses, such as those that cause the common cold. This could result in false-positive test results. Some persons may not develop detectable antibodies after coronavirus infection.

...Serologic testing by itself should not be used to establish the presence or absence of SARS-CoV-2 infection or reinfection."

-------------------------------

And here is a Reuters article quoting the CEO of Roche (which makes Covid tests) claiming that some of the other available tests are worthless.

Fauci's guy prepares us for the bad news that masks and social distancing don't work against mutated virus

The NY POST got some fascinating quotes from the Senior Scientific Advisor in Tony Fauci's office, David Morens.  Morens recently coauthored an article with Fauci (which I discussed here) in which the two of them instructed us that we need to learn to live more harmoniously with nature, or "we will increasingly provoke new disease emergences."  Yup, Fauci and Morens are telling us the pandemic is our own fault.  Here's the full quote:

"The COVID-19 pandemic is yet another reminder, added to the rapidly growing archive of historical reminders, that in a human-dominated world, in which our human activities represent aggressive, damaging, and unbalanced interactions with nature, we will increasingly provoke new disease emergences. We remain at risk for the foreseeable future. COVID-19 is among the most vivid wake-up calls in over a century. It should force us to begin to think in earnest and collectively about living in more thoughtful and creative harmony with nature, even as we plan for nature’s inevitable, and always unexpected, surprises."

Are they hinting that a reduced human population will be less susceptible to pandemics? Or that rural populations need to move?  Is the Great Reset going to control our "interactions with nature"?

Here are excerpts from the NY Post story, in which Morens again seems to be a harbinger of things to come, preparing us for the failures of masks and social distancing to prevent the spread of SARS-CoV-2.  

"David Morens, a virologist at the National Institute of Allergy and Infectious Diseases, said the findings suggest that the virus may become more contagious and that this “may have implications for our ability to control it.”

He said it’s possible that the virus had evolved to resist efforts such as hand-washing and social distancing.

“Wearing masks, washing our hands, all those things are barriers to transmissibility, or contagion, but as the virus becomes more contagious, it statistically is better at getting around those barriers,” Morens told the newspaper."

These phony public health officials have never admitted they were wrong about anything during this scamdemic.  And now, they have started invoking viral mutations (that cunningly defeat masks and distancing) to gin up the fear and keep the scamdemic going, until the public is on its knees.  And the Great Reset can begin.

Trump's former White House physician recommends Hydroxychloroquine, Zinc, Azithromycin, Steroids to treat Covid-19

https://twitter.com/HcqCorona/status/1311988691049553920

Ronnie Jackson, MD, the former White House physician who cared for both Obama and Trump, was just interviewed on Fox News.  He is running for Congress in Texas.  He basically recommended the Zelenko or Raoult protocol for President and Melania Trump, noting that all the drugs were safe.  Above is the video.  Jackson is a retired Rear Admiral and was nominated for VA Secretary, but withdrew, and returned to Texas.

Emergent BioSolutions will be paid even if the Astra-Zeneca (Oxford) vaccine flops

From Fierce Pharma:

AstraZeneca was humming right along with its partnered COVID-19 vaccine with the University of Oxford before a sudden trial hold threw its plans into disarray. So what does that uncertainty mean for AstraZeneca's expectant manufacturing partners on the shot? For at least one, it could be no issue at all. 

Despite a major commitment from AstraZeneca to help produce bulk drug substance for the University of Oxford's adenovirus-based COVID-19 shot, Maryland's Emergent BioSolutions isn't likely to feel a financial pinch if the British drugmaker's candidate doesn't make it across the finish line, Cantor analysts wrote in a note to investors Wednesday.

On the heels of AstraZeneca's troubling phase 3 trial hold, Emergent's share price dropped 5% in early Wednesday trading to $100.22 as investors appeared to show concern that AstraZeneca's setback would hit the CDMO's bottom line.

But according to Cantor, Emergent wouldn't likely come out worse for wear if AstraZeneca's candidate flops, as the partners' contract includes protections for Emergent that will see it rake in most of the $174 million owed to it in year one of the deal. 

Part of that deal, signed in July, is an $87 million portion for tech transfer and preparation that is underway, Cantor said. That money has already come Emergent's way, and further contract protections will see Emergent made whole on most of the rest, analysts argued.

The only unknowns in the event of AstraZeneca's failure would be the second and third years of the proposed contract, which could be waived, according to Cantor. However, given Emergent's close relationship with the Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), another vaccine maker could easily step into AstraZeneca's place to continue driving revenues for Emergent.

Moreover, that alternate partner could secure an even longer-term CDMO contract with Emergent at its Baltimore Bayview facility, largely taking the manufacturer's risk off the table. 

RELATED: J&J sews up 5 years of coronavirus vaccine supply in $480M-plus deal with Emergent

Despite the uncertainty of AstraZeneca's fate in the COVID-19 vaccine hunt, Emergent can rest easy knowing it has at least one other major player in the field on its side. In early July, Johnson & Johnson and Emergent inked a five-year work order worth at least $480 million to help produce the New Jersey-based drugmaker's COVID-19 vaccine candidate.

Emergent will provide "large-scale" drug substance manufacturing for J&J's recombinant DNA shot beginning in 2021, starting with a $480 million order for the first two years of the deal. For the final three years, the partners will use a "flexible capacity deployment model" to provide annual batches as needed, Emergent said.

UPDATE October 14: from FiercePharma:

Emergent has two contracts with J&J. The first, for setup and tech transfer, is worth $135 million in 2020 and 2021. The second, for drug-substance manufacturing, will pay out $480 million in the first two years...

When added to the value of Emergent’s contracts with AstraZeneca and the U.S. Department of Health and Human Services, the company is assured $1.5 billion that “is largely protected from clinical trial risk, through contract protections, meaning that [Emergent] will highly likely recognize the majority of the $1.5B in revenue, irrespective of the clinical outcome of these trials,” Cantor Fitzgerald said.

https://www.fiercepharma.com/pharma/hey-investors-covid-19-vaccine-manufacturer-emergent-won-t-suffer-from-az-j-j-trial-holds

Dr. Zelenko's Protocols for Treating Covid-19

Prehospital Management of Covid-19

Zelenko Protocol

Dr. Vladimir Zelenko

Twitter: @zev_dr

Treatment Plan for Patients with symptoms of Covid-19

Fundamental Principles 

Treat patients based on clinical suspicion as soon as possible, preferably within the first 5 days of symptoms.  Perform PCR testing, but do not withhold treatment pending results.  

Risk Stratify Patient 

Low risk patient - Younger than 60, no comorbidities, and not toxic (i.e. no shortness of breath)

High risk patient - Older than 60, younger than 60 with comorbidities, or looks toxic

Treatment Options

Low risk patients 

1. Rest, oral fluids

2. OTC Quercetin 500mg  2 a day for 7 days with Vitamin C 1000mg once a day for 7 days or     

    OTC Epigallocatechin-gallate (EGCG) 400mg once a day for 7 days

3. Elemental Zinc 50mg once a day for 7 days

4. Close follow up with doctor

High risk patients

1. Rest, oral fluids

2. Elemental Zinc 50mg once a day for 5 to 7 days. 

3. Hydroxychloroquine (HCQ) 200mg twice a day for 5 to 7 days or 

    Quercetin 500mg (OTC) 3 a day for 7 days and Vit. C 1000mg once a day for 7 days or

    EGCG 400mg (OTC) twice a day for 7 days

.

4. Azithromycin 500mg once a day for 5 days or 

    doxycycline 100mg twice a day for 5 to 7 days

Additional treatment options.  Should be uniquely custom tailored for every patient.

1. Ivermectin 6mg twice a day for 1 day   

2. Budesonide 1mg/2cc solution via nebulizer twice a day for 7 days

3. Dexamethasone 6mg once a day for 5 to 7 days

4. Blood thinners  (i.e. Lovenox)

5. Home O2

6. Home IV fluids

IF POSSIBLE, KEEP PATIENTS OUT OF THE HOSPITAL 

Supporting documents can be found here:  

https://faculty.utrgv.edu/eleftherios.gkioulekas/zelenko/index.html

Anthrax Vaccine Manufacturer to produce Covid-19 vaccines for US market

Emergent BioSolutions produces anthrax vaccine.  It used to be named Bioport, but changed its name to disguise its past.  Its products have made thousands of people chronically ill.  

It has never brought a product to market.  It has knowingly sold multiple defective products, almost always to the US government.  No one else would buy them. Yet it has inexplicably made 300% profit margins.

And now (very quietly, as none of the companies who have partnered with Emergent BioSolutions seems to want to advertise the partnership) this company will be manufacturing 3 different Covid-19 vaccines--vaccines that have already been selected by the US government for advanced development.  All three of these vaccines have entered Phase 3 (the final phase) of clinical trials.

Emergent BioSolutions will be manufacturing Covid-19 vaccines that were designed by Astra-Zeneca (Oxford University), Johnson and Johnson (Janssen division) and Novavax, a Maryland startup.

Emergent's name may not be on the label, but the company has inked Covid vaccine contracts with the US government and these 3 companies for well over a billion dollars.  

However, they don't have an operation to accomplish this--the company is built on smoke and mirrors.  Tomorrow (September 30) Emergent is hosting an online job fair, and hopes to hire 300 people.  The Covid-19 vaccines will emerge from a factory just out of mothballs, with a workforce substantially filled by new hires.

Here are Emergent's press releases making the announcements:

Let the user beware!










https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-agreement-astrazeneca-expand

https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-development-and-manufacturing

https://investors.emergentbiosolutions.com/news-releases/news-release-details/emergent-biosolutions-signs-five-year-agreement-large-scale-drug

https://www.hhs.gov/about/news/2020/08/05/hhs-dod-collaborate-with-johnson-and-johnson-to-produce-millions-of-covid-19-investigational-vaccine-doses.html

Serious concerns with the conduct of the Covid-19 vaccine clinical trials

Did you know…this past week major media outlets reported four new serious concerns about the Covid-19 vaccine trials?

•NY Times 9/22: Two vaccine experts identify a major flaw in the Covid-19 vaccine trials. The trials are focusing on whether the vaccines prevent mild disease, not moderate or severe disease which are the major concerns. (1)

•Washington Post 9/22: A former Harvard Medical School physician and AIDS researcher, Dr. William Hazeltine, agrees with the NY Times article. Further he notes that the design of Pfizer and Moderna vaccine trials is such that they could be considered a success with fewer than 100 people vaccinated. These are not nearly enough numbers to determine long-term efficacy and safety. (2)

•CNN 9/25: The AstraZeneca Covid-19 trial is still paused in the US as more information is becoming available about 2 participants in UK who experienced severe neurological autoimmune diseases during the vaccine trial. US physicians question whether the diseases are unrelated to the vaccine as AstraZeneca claims. (3)

•NBC News 9/24: Perhaps most alarming is the news that Dr. Richard Whitley, the chair of the US Data Safety and Monitoring Board (DSMB) evaluating the vaccine trials in the US, has significant conflicts of interest. In 2019 he received consulting fees from GlaxoSmithKline (GSK) which is making a COVID-19 vaccine, and he is on the board of Gilead Sciences which manufactures remdesivir. He also oversees another DSMB for GSK. The identities of the other members of the DSMB are being withheld. According to conflict of interest guidelines, DSMB members or their family members should have no professional, proprietary or financial relationship with companies sponsoring the research.  (4)

•In a Pew Research Center poll of over 10,000 Americans conducted September 8-13, those who say they would get a COVID-19 vaccine has dropped sharply with only 21% stating they would “definitely” get the vaccine. (5)

(1). https://www.nytimes.com/2020/09/22/opinion/covid-vaccine-coronavirus.html

(2) https://www.washingtonpost.com/opinions/2020/09/22/beware-covid-19-vaccine-trials-designed-succeed-start/

(3). https://www.cnn.com/2020/09/25/health/astrazeneca-covid-19-vaccine-trial-questions-fda/index.html

(4) https://www.nbcnews.com/health/health-news/secret-powerful-panels-will-pick-covid-19-vaccine-winners-n1240885?eType=EmailBlastContent&eId=4556dbf9-ab9e-4e83-b0e1-e3959583d371

(5) https://www.pewresearch.org/science/2020/09/17/u-s-public-now-divided-over-whether-to-get-covid-19-vaccine/

Compiled by West Virginians for Health Freedom.

The Economic Standard's white paper on HCQ

https://secureservercdn.net/72.167.242.48/u22.f6f.myftpupload.com/wp-content/uploads/2020/09/HCQWhitePaper.pdf

572 Belgian Doctors sign petition asking their government to change its approach to Covid-19

http://docs4opendebate.be/en/open-letter/

What if it (only) takes a new worldview to free ourselves from the new normal?

Today I told another patient that in fact, there was no need to be so worried about the pandemic.  Used early, hydroxychloroquine worked very effectively as a treatment.

And again the first thing I heard was, "Isn't that the drug Trump talked about?"

Why does what Trump said seem more germane to people than the SARS-CoV-2 virus being treatable?

I now have a retort:  "Even a stopped watch is right twice a day!"

But that is not really the point.  What remains shocking is that people have been so conditioned to fear the virus, that it is not even within the realm of possibility that there is light at the end of the tunnel.  Nor, to take an even greater leap of consciousness, are some people able to consider that, maybe, there didn't have to be a tunnel.  We have all been holed up in an imaginary tunnel, immobilized by fear and then by emergency regulations issued by fiat.

For six months, many people have known that certain drugs were very effective against SARS-CoV-2, but somehow that information has not been allowed to trickle down.

If I ask someone to believe that there is a cheap, safe, available pill that you can get in a drugstore, which could immediately end the lockdowns, masks, and the rotten new normal, I am asking them to give up believing in the world as they know it, and enter the Twilight Zone. 

I am starting to think that it is considerably harder for many people to entertain a new worldview, than it is to accept the very rotten new normal.  

The irrational fear of a cheap, effective drug/ Dr X in The Quadrant

17th September 2020

https://quadrant.org.au/opinion/qed/2020/09/the-irrational-fear-of-a-cheap-effective-drug/

 Words are very powerful. They can incite hatred and violence. They can provide reassurance and hope.  They can incite fear and dread. We have not heard many reassuring and hopeful ones this year, but maybe that is about to change. The truth is coming to light, and that is perhaps the most important issue at stake:  Truth. Public policy, affecting the lives of every person in society now and into the future, should be informed by truth.

Well here are some of those truths: COVID-19 is an extremely infectious virus that can make you very ill and might even kill you. It might also leave you with debility, pain, fatigue and seriously compromised health. It spreads rapidly in aged-care facilities with devastating outcomes.

Now here are some less palatable truths: Doctors who have successfully treated this virus have been dismissed as cranks who don’t follow “the science”. Worse, they have been denied access to the very drug that could save lives.

This last point needs to be stressed because the drug is hydroxycholoroquine – a cheap, effective, off-patent medication. Numerous papers from around the world — the number of positive appraisals grows almost by the day — are documenting its effectiveness against this virus. Used in conjunction with zinc and an antibiotic it has stopped the progress of the virus. Patients administered the drug early in the course of the infection exhibit less severe symptoms and regain their health more quickly.

Why the war against a medication any reasonable person might regard as a godsend?

On April 29, 2020, the Victorian government “restricted the sale or supply or use of the poison or controlled substance Hydroxychloroquine under section 55(2) of the Drugs, Poisons and Controlled Substances Act 1981 for a period of twelve weeks.”

 Victoria’s DHHS website still carries this message (emphasis added):

There is no clinical evidence that hydroxychloroquine is effective prophylaxis against  coronavirus

Hydroxychloroquine is in short supply and should be prioritised for use in recognised           indications including autoimmune conditions and Q-fever endocarditis.

The Pharmaceutical Society of Australia (PSA) have advised pharmacists to refuse the dispensing of hydroxychloroquine unless it is for a recognised indication.

Let us look at the underlined assertions one by one.

# No clinical evidence?

Not so, says Dr Harvey Risch, professor of epidemiology at Yale School of Public Health.

# Hydroxychloroquine is in short supply.

Clive Palmer provided 30 million doses of Hydroxychloroquine to add to the Australian stockpile.

# PSA has advised pharmacists to refuse the dispensing of hydroxychloroquine.

So, should pharmacists enjoy the right to vet and veto what a doctor prescribes in consultation with his or her patient? Not according to the Australian Medical Association:

“Doctors are the only health professionals trained to fully assess a person, initiate further investigations, make a diagnosis, and understand the full range of clinically appropriate treatments for a given condition, including when to prescribe and, importantly, when not to prescribe medicines,” [AMA President, Dr Tony] Dr Bartone said.

“The AMA urges all governments to ensure that patient care is not fragmented, misdirected, or delayed by prescribing models that do not align with the AMA’s Standards.”

On August 3, news.com.au carried an item, Record Imports of dodgy COVID cures, which I cite as but one example of the official misinformation being fed to, and regurgitated by, unquestioning journalists:

Hydroxychloroquine can cause cardiac toxicity, which can lead to sudden heart attacks, irreversible eye damage, and severe depletion of blood sugar, which can lead to coma.

The media misrepresented this drug – at no time has it been recommended that people self-medicate. The treatment protocol has always been that it be made available only under medical supervision, as with any prescription medication.

The Victorian government has effectively prevented people with Coronavirus from accessing potentially life saving treatment. It has done so, not to put too fine a point on its conduct, by telling flat-out lies.

The Premier has told Victorians “there is no vaccine for this wildly infectious virus” so we will just have to stay at home, inside, isolated and masked until the virus goes away or we get a vaccine. 

There you have it: No treatment allowed. No vaccine available. Catastrophic social and economic shutdown.

Why the full-court press against hydroxychloroquine?

Here is a further fact to ponder: It is cheap and the new anti-virals are not cheap.

Remdesivir, on-patent and surrounded by much favourable publicity when first cast as the silver bullet against COVID-19, lists at US$3120 per treatment (US$390 per vial). Alas for manufacturer Gilead’s corporate bottom line,  its bally-hooed COVID-19 ‘remedy’ has not proven effective.

So a vaccine is needed and fast. Manufacturers in the US, UK and some other countries enjoy complete legal protection against litigation for vaccine damage.

Any fast-tracked vaccine which is not adequately tested for safety and efficacy prior to administration, and for which the manufacturer has full legal immunity against any damages claims, should be regarded with great concern. It should not be mandatory for citizens to have this vaccine, as Prime Minister Scott Morrison said in an unguardedly candid moment before backing away from it.

When you follow the developments of 2020, it seems that our greatest fear should be of the governments and bureaucracies that lie to us, confine us to our homes, shut down our businesses and destroy our livelihoods, tear our families apart, turn our nursing homes into institutions of incarceration for the elderly, mandate mask-wearing and threaten us with a vaccine that would never pass any ethics approval process.

It is time to start hearing the truth.

Dr X is a Melbourne GP with 36 years in practice. He has chosen anonymity because this is Victoria, where residents must now live according to the whim and wish of Premier Daniel Andrews.

Anthrax Letters: I dissect/destroy the FBI's theory of the case, in a presentation for Lawyers for 9/11 Truth

The presentation is here, and my section starts at minute 48.

Lawyers for 9/11 Truth has today sent a petition to Congress asking them to reopen the case

Peter Breggin has supplied extensive legal documents on the challenge to Ohio's restrictive measures on Covid

Peter Breggin and his wife Ginger have amassed a library of materials on many aspects of Covid.  They were among the first to notice the questionable origin of the virus, and collected academic papers showing how aspects of the current Coronavirus had been created in labs around the world, often with funding from the US government, but also funded by the EU, Australia, China and others.

Last week he and a group of lawyers filed a huge brief in Ohio on the HCQ restrictions, and challenged a series of other emergency measures applied in Ohio. Below is this collection.

https://breggin.com/dr-breggins-covid-19-totalitarianism-legal-report/

Dr. Breggin’s COVID-19 Totalitarianism Legal Report

For Case to Stop Emergency Declaration In Ohio and Elsewhere

Please try the below links a second time if the first try does not work

Peter R. Breggin MD Expert Legal Report (PDF link) 

Overview of Breggin’s Report

Attorney Press Release

Legal Complaint

and if you go to his home page, or his coronavirus resource page, you will fined many more documents of interest.