Science at the authorities – deceptive and fraudulent!
Regulatory authorities, in particular FDA/CDER, often hold workshops to guide the industry in developing pharmaceuticals or medicines considering underlying scientific principles. However, a critical overview here highlights the falseness of science. (Continue here).
President Joe Biden said he believes the Covid-19 pandemic is “over” in an appearance on CBS’ “60 Minutes” (link).
Arguably, this declaration is about two and a half years late and caused enormous damage to society from health, economic, and social perspectives. The actual science suggested this way earlier (in May 2020, link). It is hoped that in the future, medical experts will follow the actual science, not the fake or made-up one practiced by the authorities such as FDA and CDC.
Hallucination, artistry, and fake-science
The above is a factually and scientifically accurate description – end of the debate. No more arguments, please. Because no one has shown:
Medical authorities, including from CDC and FDA, are as ignorant as anyone else about the scientific aspect of the virus and have made stupid and fraudulent claims, e.g., considering virus isolate (gunk) as pure/isolated virus.
The critical point is that most, if not all, virus-related matters are chemistry-based, and medical and biological professionals lack the needed knowledge and expertise to realize their errors. That is why they, even critical ones, have not successfully challenged or debunked the virus story.
Therefore, an independent third-party, not peer, review of the (scientific) claims is urgently needed to address the pandemic, vaccination situation, and, more importantly, the future of illnesses and medicines development business.
In the article (link), Mr. Steve Kirsch (author of the article) describes Dr. Martin Kulldorff as a “Vaccine Scientist.” Is he (Dr. Kulldorff) a vaccine scientist? Has he worked with vaccines or the virus (its isolation or testing)? Not really. As per Dr. Kulldrorff’s CV, he is a statistician and epidemiologist (sub-class of statistics). So, why is he considered a scientist?
A scientist concerning virus or virology is a person who has extensive experience in the area, most importantly isolation and characterization of the virus and potentially linking the virus to the illness or at least to the body or its fluids. Dr. Kulldorff’s expertise shows nothing in this respect. So considering him, a scientist is not a valid claim but a misrepresentation of his work or academic involvement.
A statistician or epidemiologist interprets the claim made by a scientist about the GIVEN results/data obtained from scientific/laboratory work, i.e., what are the chances of the correctness of the interpretation (not the results/data) to be statistically true?
A virus has never been isolated, its test or testing has never been validated, and there cannot be a treatment (vaccine) for a non-existing thing. So, from a scientific perspective, one cannot assess the vaccine’s good (efficacy) or bad (adverse) effect. Saying it otherwise is simply a lie or fraud.
The best one can say is observing (observational/survey data noted in the article) the effects of the injection, presumably a mixture (soup/gunk) of unknown components. One of the components is mRNA, a chemical compound that could potentially be dangerous or lethal. The danger comes from the fact that mRNA is similar in chemical structure and characteristics to the body’s DNA. There is always a possibility that mRNA gets substituted into the body’s DNA.
It is like lead toxicity, where lead ions replace similar bi-valent metals such as zinc, calcium, and iron, vital for body nourishment and survival, hence toxicity or lethality. So considering that mRNA would not interfere with the body’s RNA or DNA is a very unscientific (dumb) claim, especially when no such experimental evaluation has been done. A true scientist would not make such unsubstantiated claims.
Science requires that an experimental or laboratory study be conducted to evaluate the side effects of the mRNA. In that case, it may be done by injecting pure mRNA, which presumably should be available as it is synthetic material prepared in the laboratory or “factory.” Unfortunately, such a study has never been done. Therefore, no statistical or epidemiological assessment or claims can be valid or relevant.
So, science or scientists are nowhere to be found like the virus, but only the claims – be careful about the claims.
A few days ago, FDA responded, as a final response, to my citizen petition submitted on October 2, 2018, by denying the petition.
The response acknowledges the flaws in FDA requirements, as highlighted in the petition. However, unfortunately, the petition was denied based on irrelevant discussion and arguments on method development and validation, not on apparatuses/testers validation – the subject of the petition [link].
The petition stated that “… as per cGMP requirements every equipment, including apparatuses/testers, used for drug product manufacturing and evaluation must be validated [e.g. see 6-8] to demonstrate that the equipment or testers are qualified and validated for the intended use and purpose. However, the drug dissolution testers have never been validated for their intended use.“
In the response from the FDA, denying the petition after almost 4-years of wait or study, it is stated that “Method validation and verification encompasses the apparatus used in the method; the apparatus is not separately validated.” Therefore, confirming that apparatuses/testers are not validated, i.e., FDA (product quality) requirements are based on non-validated apparatus or testers. It infers that all methods developed using such testers and the results obtained have to be non-validated – null and void.
The 7-page FDA response covers the method validation explanation, which is separate from the apparatuses/tester validation and irrelevant to the petition’s requested action.
It is critically important to note that qualification (or “qualified tester”) represents only the physical appearance of the item, e.g., any fishing hook would qualify as a tow truck hook. However, validation establishes the relevance and usefulness of the item for the intended purpose. Therefore, a fishing hook may be qualified but not be considered validated for the intended use. The validation step can only be conducted under actual use conditions, where the fishing hook will fail to perform the towing.
Similarly, an FDA/USP dissolution tester may be qualified for dissolution testing, like a fishing hook for towing. However, the tester’s validation (relevancy and applicability) can only be established using an actual physical sample of a drug product for human use, which has never been done. So, in layman’s language, current dissolution testers are equivalent (“qualified”) to tow trucks with fishing hooks.
As noted above, cGMP (current Good Manufacturing Practices) requires the apparatuses and tester to be qualified and validated before use. Unfortunately, the FDA/USP dissolution testers have never been validated (as acknowledged by the FDA in the petition response). Therefore, they do not meet the cGMP requirements. Hence these testers must not be used or recommended for pharmaceutical product evaluation. Otherwise, it amounts to scientific fraud, as explained here.
So, to conclude, FDA requirements for assessing the quality of products using the drug dissolution technique are based on non-validated apparatuses and testers, not in line with FDA’s cGMP requirements. Their use is a clear example of stark incompetence and ignorance of the science of testing/testers and its validation at the FDA/USP. An independent third-party audit in this regard is urgently needed.
Such an independent third-party audit will also help in correcting the error made by regulatory authorities (CDC and FDA) in using non-validated (PCR and Rapid Antigen) tests for the COVID-19 virus (SARS-COV-2) assessments (see here).
It is unfortunate that people often use the word “study” in describing COVID-19. Unfortunately, the use of the word “study” is a marketing catchphrase to attract people’s attention and legitimize the views expressed.
In reality, concerning COVID-19, no study has been done or can be done. Conducting an investigation/study requires an actual or physical sample of the substance and a valid test with a measurable parameter. In the case of COVID-19, none is available, including a test, the virus (SARS-COV-2), RNA and/or protein.
Even in the case of masks’ usefulness or relevance, all studies/claims have to be fake or false, as testing a mask’s efficacy requires a physical sample of the virus that does not exist [link]. Hence, all “studies” or claims in this regard will remain unsubstantiated opinions – thus requiring frequent flip-flopping.
In addition, people do not realize that opinions/stories of virus mutation are examples of the flip-flop to hide the lack of vaccine relevance or efficacy, as vaccines have never been tested against the virus [link]. It is a scientific fact and not an opinion.
Just be careful when reading the literature or listening to “scientific” or “expert” opinions.
Someone, this morning, pass it along a question to me asking a response as to
“Why would vitamins need PEG in there?”
The inquirer refers to the ingredient (Polyethylene Glycol or PEG) on the vitamin bottle label. I provided the following response. I hope visitors to my website will benefit from my reply as well.
Medicine is an actual drug (also called an active ingredient) in a product. For example, Tylenol is not a drug or medicine (but a package containing the drug). In the case of Tylenol, the actual drug is a chemical compound called acetaminophen.
So, if one needs to take Tylenol, one can take acetaminophen powder in the tablet equivalent quantity, which will have the same therapeutic effect as the tablet. Chemical manufacturers and suppliers usually sell these powders of drugs, such as acetaminophen.
On the other hand, to make a tablet or other drug products (capsules, creams, suspensions, suppositories, etc.), one needs to add several ingredients (called inactive ingredients). This addition is done to make the product STABLE for use so that the user gets the exact amount of drug as intended.
So, one uses these ingredients to make products for the CONVENIENCE and accuracy of getting the drug from a tablet/capsule. It is not only the PEG. All others mentioned under the “other ingredients” category serve the same purpose (i.e., tablet/product manufacturing).
How toxic or safe to use are these inactive ingredients is a separate issue. Usually, such evaluations are done in animals (maybe humans, from historical data). In this regard, literature provides information about acceptable use and safe amounts for inactive ingredients. Hence they are considered safe to use.
However, on a personal note, one should undoubtedly watch their excessive use, just like excessive use of anything is not a healthy habit. The scientific studies, in this regard, are usually short-term and not thorough; hence always leave doubts about the safety claims.
COVID-19 and SARS-COV-2 are based on PCR tests, which by definition, is not valid test. In simple terms, the PCR test does not test/detect a virus or its infection – it cannot. Unfortunately, people in general, experts/physicians in particular, are unaware of this fact. Instead, they are blindly following the fed narrative.
Suppose a thermometer (tester) shows a high temperature (fever) for an otherwise healthy and happy person. In that case, it does not mean the thermometer is telling a hidden fever or illness, but the thermometer is faulty. Unfortunately, this is how often positive PCR results are interpreted for COVID-19, e.g., see here (link) – an utterly wrong interpretation.
Therefore, as the (PCR) test is fake, the virus and its associated illness and treatment are fake too.
If you would like to discuss this aspect in further detail, please seek help from someone who is trained and works in the science of testing, i.e., test method development and validation. Professionals (such as physicians, immunologists, virologists, microbiologists, molecular biologists, and epidemiologists) would not be able to help. These professionals have no or limited training and understanding of the subject (test development and validation). They are as confused in this regard as anyone else and make false decisions and claims.
A recent article states that Pfizer quietly admits it will never manufacture original FDA approved COVID vaccines [which is named Comirnaty](link).
Comirnaty was a shell game to deceive the public that “now” mRNA is an “approved” product, not EUA. In one of my posts, I clearly described this deception that there can’t be an approved product because to have an approved product, the EUA product has to be withdrawn, which never happened. link
On the other hand, it appears that the vaccination days are numbered. There are two reasons:
(1) lack of efficacy/benefits of vaccination and widespread acknowledged severe adverse effects, including deaths;
(2) Full scientific data has to be submitted to the FDA (I believe by 2023) to establish the safety and efficacy of the EUA vaccines, which is not forthcoming. Safety and efficacy cannot be established without the availability of the isolated and purified virus, which is unavailable.
Furthermore, the recent (August 11, 2022) changes in CDC guidelines support this view, which states,
“COVID-19 remains an ongoing public health threat; however, high levels of vaccine- and infection-induced immunity and the availability of medical and nonpharmaceutical interventions have substantially reduced the risk for medically significant illness, hospitalization, and death from COVID-19.” link
It means that majority are immune (vaccinated or not), so obviously, there is a limited or no need for vaccination.
Secondly, per guidelines, “People who have symptoms of COVID-19 or who have had known exposure to someone with COVID-19 should be tested for COVID-19.” (link). Asymptomatic would not require testing – this is huge. This will significantly reduce testing numbers (hence positives). This would indicate fewer COVID-19 positives – which will help declare that the “battle” won against the pandemic. Hence no or limited use of vaccination and, by extension, discontinuation.
Move on to the next “project.” It does not have to be real or genuine, but a bigger and better one – must “follow the science”!
