Clinical trials are specific type of tests in which products or treatments are tested using human subjects. Such trials should be conducted under the management of analytical science or laboratory with scientifically valid protocols. Unfortunately, however, at present trials are conducted in non-analytical science facilities and supervision often with invalid study protocols and interpretations. Approved products based on such trials would provide false assurance of safety, efficacy and quality of the tested products. Patients and public should be aware of current flawed scientific practices in this regard. On the other hand, if such evaluations are conducted with appropriate and scientifically valid and proven approaches, one could not only avoid false mishaps but also develop treatments and cure far more expeditiously and cost effectively. click here or here to read complete article
Author: Dr. Saeed Qureshi, Ph.D.
The COVID-19 pandemic has been established based on testing patients and the general public. Therefore, it is a legitimate question to ask that the authorities and/or experts provide the details and validation data of the tests they have used to establish the presence of the actual virus (SARS-CoV2) and/or COVID-19. On the other hand, it is also common knowledge that a scientifically valid COVID-19 and/or virus test is neither available nor can be developed. Therefore, it becomes a fact that the presence of the virus and its disease, and by extension, the pandemic, cannot be established and confirmed. In short, the disease and pandemic do not exist, and authorities consider declaring the COVID-19 pandemic claims to be ending. (1, 2)
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
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.
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.