Fraudulent drug safety studies have destroyed medicine; "Safety" researchers ignore lot-to-lot variation but in reality 100X difference in contaminant level, adverse events, is common

Latest example is study fraudulently claiming no association between COVID-19 vaccines and Bell's palsy. Fraudulent studies are lucrative. Researchers collect millions from Pharma as FDA aids/abets.

A recent study in the BMJ claimed no association between COVID-19 vaccines and Bell’s palsy. However, it is obvious from the Pfizer and Moderna trials that the vaccines induced Bell’s palsy. The 7X difference in the number of Bell’s palsy cases observed between vaccine and placebo arm has only a 0.007% probability of being a chance occurrence. In other words, 99.993% probability, the vaccines caused the cases of Bell’s palsy.

The Pfizer/Moderna trial being randomized controlled trials (RCT) are considered to be the "gold standard". They identified huge imbalances of Bell's palsy cases between vaccine and placebo arms. But even these "gold standard" trials are faulty because no one knows if the lots used in the trial are representative of the worst of the billions of doses that will be shipped.

So why this difference between the BMJ study and the trials?

The BMJ study analysis and results are invalid like most such studies that ignore batch-batch/lot-lot variation among vaccines. 100-fold variation in contaminants have been reported.

There are significant variations in the egg protein content between the different brands and different lots of flu vaccines, varying by over 100-fold in some preparations.

By ignoring lot-lot variation, the huge number of adverse events observed in a batch/lot are diluted across many lots. So the effect becomes easier to cover up with the statistical analysis.

E. coli protein contamination of Pfizer, Moderna mRNA vaccines

The Pfizer vaccines are contaminated with E. coli proteins.

These hold hundreds of gallons of an amber-colored solution containing specially designed E. coli bacteria.

Same for Moderna.

All enzymes utilised are produced in E. coli.

The biotechnology industry will NEVER EVER purify anything properly. Because it costs money and cuts into profits. With no product liability, why bother. The AstraZeneca COVID-19 vaccine is contaminated with ~2000 human proteins from the growth culture. It therefore causes anti-PF4 autoimmunity in 67% of the recipients and immediately kills some by causing VITT/CVST.

Such E. coli protein contamination will result in at least two kinds of adverse events. E. coli are commensal bacteria in the human gut. So we have a very sophisticated immune response to tolerate E. coli unless it is pathogenic. The contaminated vaccines will destroy this response and program the immune system to unconditionally attack E. coli. The result is gastrointestinal disorders such as Inflammatory Bowel Disease (IBD).

E. coli proteins have high homology to numerous human proteins. The vaccines force an immune response against E. coli proteins due to the adjuvant effect of lipid nanoparticles (LNP) used in the mRNA vaccines. The result is an attack against human tissues due to cross-reaction - autoimmunity.

The LNP vector can have an adjuvant effect by itself

A quick analysis confirms numerous protein sequence matches between autoimmune epitopes in the Immune Epitope Database (IEDB) and E. coli proteins.

Example: Homo sapiens 60 kDa heat shock protein, mitochondrial vs. E. coli BLASTP result.

This epitope is involved in autoimmune diseases of the cardiovascular system.

Such epitopes with one or two amino acid residue differences are ideally suited to cause autoimmune diseases.

Variation in E. coli protein contamination is one reason for lot-to-lot variation in adverse events.

Lot-to-lot variation

The US VAERS shows Bell's palsy reports have a 40X variation from lot to lot.

Deaths vary 150X from lot to lot.

Such variation also proves that VAERS reports are not a coincidence but causal.

Source: Bell's palsy Anaphylaxis Death Myocarditis

The FDA unsuccessfully tried to hide Bell’s palsy being an COVID-19 vaccine adverse event but was caught by their own VRBPAC member.

Therefore, the observed incidence of Bell's palsy in the vaccine arms is between 3·5-times and 7-times higher than would be expected in the general population. This finding signals a potential safety phenomenon and suggests inaccurate reporting of basic epidemiological context to the public.

In my comment published in the Annals of Internal Medicine, I describe the details of why drug safety studies in general, including vaccine safety studies, are invalid.

Vinu Arumugham Independent Researcher 7 March 2019

MMR and autism study is fundamentally flawed

Vaccines are not created equal

The purpose of publishing this study is to use the results worldwide. The assumption is that the MMR vaccine covered in the study is representative of vaccines used worldwide. But that assumption is false. There are no specifications that control the thousands of antigens in the vaccine from the chicken embryo cell culture used to grow the viruses or excipients such as gelatin(non-target antigens (NTA)).

We have seen repeatedly that adverse events can be caused by NTA.  

Gelatin or egg protein containing vaccines caused the development of allergy to those antigens. (1)⁠ The latest example is Pandemrix vaccine induced narcolepsy. Pandemrix manufactured in Europe contained larger amounts of H1N1 nucleoproteins (an NTA) and resulted in way more cases of narcolepsy, compared to Arepanrix manufactured in Canada (2)⁠. 

Egg protein amounts in vaccines vary by orders of magnitude,among vendors, batches and over time. (1)⁠

Bovine casein content varied 2-fold in just eight vaccine samples. 

Engerix vaccine contains 500% of the yeast proteins as the Recombivax vaccine.⁠

Due to such variation among vaccines, the study results are rendered inapplicable and the purpose of the study is defeated.

⁠Autism mechanisms

There have been many developments in autism research in the last two decades that the authors have ignored.Antibodies directed against folate receptor alpha,GAD65, glutamate receptors and other antigens, in the child or the mother, can cause autism⁠. Multiple vaccines can induce these antibodies in the child or the mother (3)⁠. 

Cow’s milk protein containing vaccines (DTaP) cause the vast majority (75%) of autism cases (4)⁠. A subset of autism can be caused by GAD65 antibodies that are induced by GAD65 proteins in the MMR vaccines. GAD65 can be of chick (cell culture) or animal (gelatin) origin. Maternal antibodies can affect the fetal brain (3)⁠. Epidemiological studies cannot account for these variables.

Epidemiological studies

The US IOM committee in their 2011 report (5)⁠ wrote:

“The committee concluded the evidence convincingly supports 14 spe-cific vaccine–adverse event relationships. In all but one of these relation-ships,the conclusion was based on strong mechanistic evidence with the epidemiologic evidence rated as either limited confidence or insufficient.” 

So in an overwhelming 93% of cases, mechanistic studies provided convincing evidence and epidemiological studies failed. 

This study is therefore flawed, misleads and must be retracted.

References

1.Arumugham V. Evidence that Food Proteins in Vaccines Cause the Development of Food Allergies and Its Implications for Vaccine Policy. J Dev Drugs. OMICS International; 2015 Oct;04(04):1–3.  

2.Godlee F. A tale of two vaccines. BMJ. 2018 Oct4;363:k4152.  

3.Arumugham V. Vaccines and Biologics injury table based on mechanistic evidence – Mar 2019[Internet]. 2019. Available from: https://doi.org/10.5281/zenodo.2582634

4.Arumugham V, Trushin M V. Autism pathogenesis: Piecing it all together, from end to beginning …. J Pharm Sci Res. 2018;10(11):2787–9.  

5. Clayton EW,Rusch E, Ford A, Stratton K. Adverse Effects of Vaccines:: Evidence and Causality. National Academies Press; 2012. 

The FDA is paid to ignore fraud.

There is an industry around creating such fraudulent “safety” studies. Some authors specialize in such fraud and collect huge sums of money from pharmaceutical companies for this service.

The French drug giant Sanofi and other companies paid him at least $1.2 million for trials conducted between the time FDA detected his falsified exams in 2016 through 2019, according to the federal Open Payments system, which tracks pharmaceutical industry payments to doctors.

Yet the work kept flowing from Sanofi to his research business even after he was disqualified. Sanofi assigned responsibility for Baker's trials to another doctor at his center, which Baker operated with his dermatologist wife in the same building as their medical practice.

Nicola Klein of Kaiser Permanente is an egregious example, collecting $75 million from the same Pharma serial criminals.

As for why there is so much variation in contaminants/adverse events from lot to lot, poor process control to save money could be one reason. Another reason may be that vaccine plant workers peed in the tank or worse. And unfortunately under Operation Warp Speed schedule pressure, that is not a joke.

The allegations described a biohazard nightmare. Workers appeared to be defecating and urinating in their uniforms, and feces had been found smeared on the floor of the plant’s production area, the letter alleged. In a sterile manufacturing plant, bathroom breaks can be difficult to take because they require additional time, which could serve as one possible explanation for the events inside the Merck plant. Ungowning can take 15 minutes, regowning can take 15 minutes, and on a night shift, there may be no one else to cover an essential worker during that time, Menachem said.