Open letter to physicians, pharmacists & laboratory managers

Written by Saeed A. Qureshi, Ph.D. on February 23, 2022. Posted in Current News

Note that the tests currently conducted for establishing the virus or COVID-19 are scientifically invalid.

Therefore, conducting such tests and interpreting their results may be considered fraudulent – punishable by law. See the explanation below, and please take note of it.

A recent (2022) example highlighting the issue is the shutting down of Theranos lab ($9-billion valuation), which claimed to have developed a blood test (link).

“Holmes and Balwani used advertisements and solicitations to encourage and induce doctors and patients to use Theranos’s blood testing laboratory services, even though, according to the government, the defendants knew Theranos was not capable of consistently producing accurate and reliable results for certain blood tests.

It is further alleged that the tests performed on Theranos technology were likely to contain inaccurate and unreliable results.” US v. Elizabeth Holmes, et al., The United States Attorney’s Office, Northern District of California. (link)

“Theranos founder Elizabeth Holmes has been convicted of defrauding investors after a months-long landmark trial in California. Prosecutors said Holmes knowingly lied about technology she said could detect diseases with a few drops of blood.” (link).

In scientific terminology, the company promoted a non-validated test. The PCR and Rapid Tests fall in the same category, i.e., a non-validated swab test to detect the virus or COVID-19 illness.

Author’s academic background and expertise:

I am a retired research scientist who worked for Health Canada for 30 years in assessing the quality of pharmaceutical products. As a bench scientist, I was considered a resident expert for providing advice relating to drug product applications for marketing purposes.

These roles allowed me to interact with other international regulatory agencies, including the FDA, to develop and apply regulatory standards.

I have an academic qualification with a Ph.D. degree in analytical-organic chemistry, which provided a strong background in developing, validating, and applying tests for product evaluations.

I worked independently in toxicology, pharmacology, and pharmaceutical areas at Health Canada. I learned most of these subjects by taking undergraduate and graduate-level. Combining this training with my chemistry expertise and benchtop research provide me a unique perspective of the medical and pharmaceutical subjects, rarely available.

As expected, as a scientist, I have published many research articles and reviews in international peer-reviewed journals and participated in numerous international conferences, including organizing a couple in North America and Europe.

For the past six years, I have contributed as a freelance scientist, providing suggestions for improving the products’ quality. At present, this is mainly offered through my web blog (link).

Testing of virus and its illness (COVID-19):

My involvement with pandemic started with observing the scare of getting the illness and potential death among people. In my view, the numbers of deaths reported were well within the average attrition rate. However, patients were labeled with COVID-19 based on testing. As noted above, being a developer and user of tests during my career, hearing the word testing; naturally got my attention and curiosity to dig deeper into the testing aspect.

There have been two different tests commonly mentioned for COVID-19 or virus testing:

The PCR test monitors a virus component called RNA (ribonucleic acid). RNA is a long chain chemical compound, a polymer such as starch; hence RNA naturally becomes testing of a chemical compound.

Antigen test, commonly also known as a Rapid Test, does not monitor virus either; still another component of the virus, i.e., a long chain chemical compound called spike protein.

In short, it should be clear that, at present, no direct testing of the virus or its illness is conducted, but by indirect testing of RNA and spike proteins.

To validate a test means demonstrating that the test can monitor what it is supposed to monitor, i.e., virus RNA or spike protein. For validation of the test, there are at least four primary requirements to meet:

(1) It should be sensitive enough to detect the item;

(2) the test should be repeatable or reproducible;

(3) it must be specific, i.e., it should able to see the item without the interference from other co-existing impurities;

(4) a pure and certifiable reference product must be available, i.e., RNA or spike protein. The critical aspect is that if the reference standard is not available, the other three items mentioned, i.e., specificity, sensitivity, and reproducibility, cannot be established.

Unfortunately, no reference standard of RNA or spike protein is available from any source. Therefore, it is impossible to develop or have a valid test for RNA or spike protein and, by extension, virus or its illness.

The reference RNA and spike protein could only be obtained from the virus. However, unfortunately, no virus has been  isolated thus far. At present, laboratories are using computer-generated imaginary molecules, which have no link to the reality of the virus or its illness.

Hence, the use of PCR or Rapid test for the virus or COVID-19 becomes unscientific, invalid, and fraudulent that must not be relied upon for any purpose, including medical (COVID-19) diagnosis.

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