Author Archive

Science for the pandemic at the authorities: false in fact fraudulent – requires urgent action!

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

Pandemic: why and how? Certainly testing is irrelevant!

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 a 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 does 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)

Will therapeutics/vaccines be developed for COVID-19? Of course – but only fake ones!

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

Media and bureaucracy can produce anything (virus as well as 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 testers come with 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 presence/absence of COVID-19, and/or its treatment/cure, MUST be considered unscientific or false.

Do FDA and USP lie? Of course, all the time!

For example:

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

FDA claims that it establishes 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. A lie – these tests, along with associated testers, have never been validated for the intended purpose. In fact, these tests have been shown to be scientifically invalid and irrelevant for their intended purpose.

USP claims that it provides reference standards for establishing 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 falsely promotes as reference standards of medicines.

USP claims that it provides a valid analytical test for the assessment drug release characteristics of the products for establishing and monitoring quality of the products. A lie – the test has never been validated for the intended purpose. The test cannot determine 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. Manufacturers and patients should be cautious in accepting such claims from FDA and USP as well as 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) for addressing the underlying lies concerning products development, manufacturing and their regulatory approval.

Pharmaceutical products quality assessments – future!

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]. Not only such studies put large burden, financial and personnel, on the industry as well regulatory authorities for the development, manufacturing and approval of products but also 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 the 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 [5].

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