Recent Court Decision Will Hopefully Address Govt Agency Incompetence/Fake Science

For example:

(1) Most safety, efficacy, and quality of medicines/pharmaceutical products assessments, particularly oral dosages such as tablets and capsules, are based on a drug dissolution test and correspondingly using a drug dissolution tester.

However, the testers have never been validated for their use, i.e., can they determine the products’ valid and relevant drug dissolution characteristics? It has been repeatedly shown that this tester  cannot provide valid and relevant results, hence the quality of the products and, by extension, safety and efficacy.

However, the test and its requirements continue as per FDA Guidance documents (contrary to Congress’s intent of producing quality products).

In real life, if anyone uses a non-validated test, it is considered illegal/crime, and the promoter is usually dealt with immediately and swiftly, but not the agencies (linkk).

In a challenge to this practice, a Citizen Petition to the US FDA was submitted requesting the discontinuation of the practice and its requirements. However, after four years of evaluation, the flaw (lack of validation of the testers) in FDA-recommended dissolution testers was acknowledged, as highlighted in the Petition.

Unfortunately, the Petition was denied based on irrelevant discussion and arguments on dissolution method development and validation, not on apparatuses/testers validation – the subject of the Petition. It clearly shows a lack of understanding of the subject/science of product evaluation at the Agency (link). Therefore, agencies have final authority in making logically and

scientifically false decisions that are not in line with lawmakers’ intent, and this needs to be addressed.

(2) Clinical tests (called clinical trials) are considered the gold standard for evaluating pharmaceuticals.

This sledgehammer approach establishes the superiority of medical “science” over others, as no one can do or is allowed to do the clinical trials but physicians. Have these tests/trialsbeen validated to be scientific and produce relevant or valid results ordata?

The simple answer is no.

Let me explain this with an example of evaluating or comparing generic products against brand-name ones. They are done based on clinical trials called bioequivalence studies. Here, healthy human volunteers are given separate doses of brand-name products vs generics.

Blood drug levels (markers of dosage efficacy) are measured and compared with each other. If the drug’s blood levels fall within the “accepted” range (roughly plus/minus 20 percent). Then, the products are considered similar, which means they will be equally safe and effective and can be interchangeably prescribed.

The assumption is that if the blood levels fall outside the accepted range, the product will be considered inferior to the brand name. In short, bioequivalence tests are done to establish the quality of the product to see if products are similar (with a 20 percent difference). Where does the 20 percent difference come from, and can the bioequivalence test see this 20 percent difference?

The answer to both is no regarding the 20 percent difference (a number out of a hat) and whether the method can see a 20 percent difference.

In a study, it is established that the bioequivalence method itself can provide 20 percent and higher variability in testing (link). It cannot see the difference in product variability, often less than 20 percent. In reality, the method considers the variability of the test itself, not that of the product as presumed.

In simple terms, one is trying to establish the weight and accuracy of a small jewelry item with a large weighing scale having a much higher tolerance than the weight of the jewelry piece. This is an excellent example of a lack of understanding and competency in science/chemistry.

However, the situation cannot be corrected as, in the Agency’s view, it is “science” and valid and can be used to apply for product approval. This clearly misrepresents Congress’s intent to providesafe and effective drug products.

(3) A recent example of such misrepresentation is the “science” behind COVID-19, its pandemic, and its vaccine development.

It is important to note that the diagnosis of any illness is established by a test specific to it or its cause; in this case, it is a virus called SARS-COV-2.

It is critical tonote that a test cannot be developed for something if its sample(reference) is unavailable. No sample of SARS-COV-2 is available.

Hence,it is impossible to develop a diagnostic test for it. Hence, scientifically, itis clear that there is no virus or illness, and the suggested tests aresimply a scientific lie. The nation or the world is in the grip of a false virusand is treated with vaccines for a non-existent illness.

The only reason such erroneous and scientifically incorrect standards/methods are allowed is the belief that the Agency’s experts know and practice the science, which is a wrong assumption.

These decisions or interpretations are made mainly by medical and pharmaceutical experts who do not study science, and no auditing mechanism is available to correct the situation.

The recent court decision should allow the courts to conduct independent evaluations or audits. It also provides opportunities for academic and industry scientists, often unheard and suppressed, to seek independent audits of the science at the Agencies.

Not only will it save a vast amount of resources, but more importantly, it will allow people to live and interact with one another freely without fear of non-existing illnesses and avoid unnecessary medicines, including vaccines.

See more here bioanalyticx.com

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