Author: Dr. Saeed Qureshi, Ph.D.

If FDA approves or disapproves something, it is assumed that it has to be good or bad, respectively, based on its scientific merit. However, unfortunately, FDA assessments, in general, are not based on science at all. It would be hard to believe, but it is a fact that cannot be denied.

For example, it is generally believed that the FDA establishes the quality of the pharmaceutical products and their safety and efficacy by extension. It is a false claim or belief. FDA never defines the quality of a, or any, product. Obviously, if a parameter is not defined, it cannot be measured or established. (link)

The current situation of approving vaccines (full or otherwise) follows the same criteria. The claims have been made that vaccines are effective against the virus or COVID. However, vaccines have never been tested against the virus or COVID. No one has isolated or seen the virus, so how could something be tested against it – it can’t be. A marketing tactic to promote untested products. (link).

The CDC did not work with any (patient) swab samples or virus isolates for developing or validating the PCR test but with a mixture of a suspension of human cells and a viral transport medium (VTM) to mimic clinical specimens. The VTM often contains several ingredients such as Hanks balanced salt solution, and heat-inactivated FBS (fetal bovine serum), gentamicin sulfate, and amphotericin B. This mixture was spiked with synthetic and lab-processed particles of a chemical compound, RNA (in CDC’s terminology, “characterized stocks of in vitro transcribed full length RNA”) to assume as the SARS-COV-2 virus*. The chemical compound or particles have no link to the COVID virus, illness, or patients. This spiked mixture is used as a reference standard for the SARS-COV-2 virus, i.e., the CDC gold (reference) standard. So, CDC and others test providers look for the synthetic and lab-processed particles and tell that they are testing for the SARS-COV-2 virus.

Not only do the particles have no link to the virus, but the nature of the PCR test is such that it can detect the same or similar particles (“cases”) from different sources. Another way of saying the same thing is that the PCR test has no specificity and validity. That is why the CDC makes repeated disclaimers, in the document (Page 3, 10 & 38), concerning the lack of accuracy of the test.

*Source: CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (link), p. 40

Yesterday someone asked a question about the meaning of isolating the virus. I am sharing the question and my reply here, considering that it would be helpful to the visitors of this blog as well.

Question: Can you please help me understand what is the meaning of isolating the virus? I mean, what does it mean? How should it be done?

Reply: Isolating or extracting something means separating it from other components usually present in the natural environment. It is a standard process or practice to obtain a purified component for further study or larger use. For example, most, if not all, metals such as gold, copper, uranium are isolated/extracted from their ores.

The process of isolation may be explained as follows.  If one takes sugar cane, crushes it, squeezes it to get the juice out, and then concentrates it by boiling. Leaving the concentrate at room temperature will result in the crystallization of sugar as pure white particles. Thus, the process would be called the isolation of sugar from sugar cane.

Concerning the virus, it means that the virus has been separated from the content of the swab sample. In the end, virus as particles should be available in a test tube or vial.  This purified specimen should be used to develop test methods, study illness, and develop treatments, including vaccines.

Unfortunately, this isolation part for the virus has never been done. Hence no pure isolated specimen is available. Therefore, neither tests for the virus can be developed nor the treatments, including vaccines.

Stating otherwise is simply spreading misinformation and promoting fake science.