Author: Dr. Saeed Qureshi, Ph.D.

If people are not aware of the Theranos’ blood testing scandal, a quick Google search will reveal the details. The following is from Wikipedia (https://en.wikipedia.org/wiki/Theranos).

“Theranos was a privately held health technology corporation. It was initially touted as a breakthrough technology company, with claims of having devised blood tests that required only very small amounts of blood and could be performed very rapidly using small automated devices the company had developed. However, the claims later proved to be false.”
“After all efforts to find a buyer went nowhere, what remained of the company dissolved on September 4, 2018.”

The underlying cause of Theranos’ demise, a reportedly 10 billion dollars valued company, was promoting and selling non-validated test or testing.

Similarly, if one would request validation data for COVID-19 testing (presence/absence of virus and by extension its disease, not of some non-specific proteins) in particular from authorities/experts, it will immediately become clear that claims of testing/pandemic are false. However, in this case, authorities are making and accepting false claims for the testing and avoiding the Theranos like demise which would be unavoidable for a long. Request the authorities to provide validation details of the available COVID-19 tests? The pandemic will disappear very quickly as did the Theranos.

For requesting validation protocol/details please follow the links (1, 2).

Also published as “COVID-19: Vaccine ‘Not Possible’ for a Virus Not Yet Quantifiable” On Principia Scientific International site (link).

It is often claimed and promoted by the regulatory authorities, in particular CDC/FDA, that the current Coronavirus (SARS-CoV2/COVID-19) pandemic, in particular in the USA, is based on science and the associated data or facts. It is claimed that virus causes the infection which in turn causes or may cause human deaths potentially in millions. Furthermore, it is also claimed that a viral disease (COVID-19) can only be treated with a vaccine, which at present does not exist, and must be developed urgently and made available to the public worldwide.
Let us evaluate these claims on scientific basis. For complete article, click here

Link or Link

Considering the statements below, from a randomly selected fact sheet FDA approved under Emergency Use Authorization or EUA, the current antibody testing lacks scientific validity. This is really sad that such tests [kits] are being promoted or used to establish COVID-19 [1]. As noted below the test monitors protein levels commonly known as [IgM, IgA and IgG] not specifically COVID-19. Logically data obtained from such tests should be avoided in making predictions or projections about the infection and its spread. It certainly is false science.

1. “A positive result with VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test may not mean that an individual’s current symptoms are due to COVID-19 infection.”
2. “However, a negative result does not rule out COVID-19.”
3. “The absolute sensitivity of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is unknown.”
4. FDA statement [2] “This limits the test’s effectiveness for diagnosing COVID-19 and why it should not be used as the sole basis to diagnose COVID-19.”
In addition, if vaccines would be developed based on such antibody tests, which do not appear to be sufficiently validated as noted above, then how reliable and valid vaccines would be? Please be cautious with claims in this regard.

Some other related links: (1, 2, 3)

A logical and scientific requirement for such (i.e., development of therapeutic/vaccine) is the availability of a VALID analytical/clinical test to establish the presence/absence of Coronavirus (COVID-19). However, unfortunately, at present, there is no such VALID method exists. Therefore, scientifically speaking, it is impossible to establish the presence/absence of COVID-19 in humans with sufficient accuracy/specificity and, by extension, the development of its treatment/cure either by pharmaceuticals or vaccines.

Media and bureaucracy can produce anything (virus and its treatment) out of thin air; that is a different story. If people like to believe in such stories, then that is their problem.

Every test and/or tester comes with a calibration/validation certificate. Similarly, COVID-19 test has to have calibration/validation based on parameters, i.e., method validation data such as (1) accuracy; (2) precision; (3) specificity; (4) references used to validate the method. It is a standard and normal practice/requirement for any analytical/clinical test. Unfortunately, this is missing. Hence all the claims made about the presence/absence of COVID-19 and/or its treatment/cure MUST be considered unscientific or false.

For example:

FDA claims that it establishes and monitors the quality of pharmaceutical products such as tablets and capsules. A lie – FDA neither defines the quality of the products nor its measurable parameter; hence it does not, or cannot, determine the quality of the products.

FDA claims that it establishes the safety and efficacy (as well as quality) of pharmaceutical products using valid clinical testing (e.g., bioequivalence assessment) and in vitro (drug dissolution) testing using USP apparatuses. Again, a lie – these tests and associated testers have never been validated for the intended purpose. In fact, these tests are scientifically invalid and irrelevant for their intended purpose.

USP claims that it provides reference standards for establishing the quality of the pharmaceutical products such as tablets and capsules. A lie – USP never provides reference standards for any product. It provides powder or liquid samples of pure chemical compounds, not the products which patients use. However, it falsely promotes reference standards of medicines.

USP claims that it provides a valid analytical test for assessing drug release characteristics of the products for establishing and monitoring the quality of the products. A lie – the test has never been validated for the intended purpose. The test cannot determine the drug dissolution/release characteristics of any product. It has been shown experimentally that the test provides irrelevant and highly unpredictable results/data with no relevance to product quality.

For more examples, please visit here and here. Manufacturers and patients should be cautious in accepting such claims from FDA and USP and other national and international authorities, which often follow FDA/USP claims and guidances.

Please consider accepting the Citizen Petition (under review with FDA for more than a year and a half, link) to address the underlying lies concerning products development, manufacturing, and their regulatory approval.

What should one expect, after FDA completely destroyed, and rightly so, the credibility and usefulness as well as need for bioequivalence assessment (aka clinical trials) by removing its requirement from ANDA approvals, at least for hydroxychloroquine (HCQ) and chloroquine (CQ) products to start with [1, 2]? It is to be noted that bioequivalence assessments have been shown to be scientifically invalid and irrelevant to establish the quality of the products based on their drug release assessment [3]. Such studies put large burden, financial and personnel, on the industry as well regulatory authorities for the development, manufacturing and approval of products and expose healthy human subjects, in particular young adults, to potent chemicals (a serious unethical practice).

Products can easily and accurately be assessed using drug dissolution testing. However, to implement its (drug dissolution testing) valid use, authorities, including FDA and USP, need to implement appropriate and scientifically valid dissolution testers and methods. Until then, authorities’ claims regarding monitoring and establishing products quality will remain false and invalid.

COVID-19 pandemic exposed the burdensome and unnecessary regulatory practices and requirements. It also provides an opportunity to simplify product development and manufacturing. Please consider the under-review Citizen Petition for removing the use of non-validated/non-qualified, hence non-GMP, USP drug dissolution testers/tests from regulatory requirements [4] and replace them with appropriate and scientifically valid tests and testers.

We, the authorities and experts, are extremely sorry to inform you that we made a colossal mistake in declaring the Coronavirus (COVID-19) pandemic. It is one of such rare situations where we found out at an extremely high cost (human and financial) that our scientific understanding of the subject was flawed and failed us. As a result, we honestly carried away with our projections and fear of a huge number of anticipated deaths by the potential spread of this variant flu, which clearly did not come out to be correct. We sincerely regret this unfortunate situation and ask for your forgiveness. Please accept our apologies. We hope the public will forgive us and start their usual daily life. In addition, we hope that the public will avoid the use and/or development of new medicines based on our falsely classified disease and pandemic, reducing any further damages that may occur.

Once again, we sincerely apologize and hope that we will be forgiven.

In general clinical trials are important and necessary. In any other area, one has to show that the “things” (in this case, medicines/treatments) work as expected – clinical trials serve such a purpose.

However, underlying scientific concepts and practices in the medicines area are extremely poor; hence “clinical trials” practices face credibility issues. For example, developing products (tablet/capsule) clinical trials (bioequivalence test – regulatory requirement) are conducted, lacking clinical relevance and usefulness. Therefore, it could be argued that such tests indeed expose subjects, often healthy human volunteers, needlessly to potent chemicals in the name of medicines development. (link)

Similarly, relating to the Coronavirus pandemic, there appears to be a rush towards the development of medicines/vaccines. It may be argued that as the underlying analytical science is not well-established to monitor the virus and/or its “disease,” it would be challenging to conduct appropriate and validated “clinical trials” (link)

In short, running clinical trials is a good idea. However, conducting appropriate and useful clinical trials remains challenging; that is where the confusion is.

1. Flu came and gone!
2. Why it was called a pandemic – not clear
3. Discredited the benchtop science – as disease state-monitored with charts and their shapes (humpy or dumpy) with protocol/testing developed on the fly
4. Discredited  the medicines approval system with the approval of medicines without requiring established protocols
5. Treatments could be suggested and implemented without having knowledge or expertise in the area of medicine.
6. Exposed the great weakness, perhaps more accurately ignorance, of “science” at the authorities!
7. Hope we learned something not to repeat in future

Further readings:

(1)Coronavirus pandemic: Public/patients deserve better! (link)
(2)Authorities (including FDA) and pharmacopeias (including USP) never establish the quality of products! (link)
(3) Is Coronavirus really causing an abnormally higher number of deaths? (link)