Public health and WHOClinical trials whose results were not published — what has been hidden from us?
Sources: 14 · Article: 16 399 characters
Jerzy Zięba claims that reports of serious side effects have not yet been presented in the results of ongoing clinical trials.
- According to him, two people reportedly suffered anaphylactic shock after the first dose, and four developed Bell’s palsy; no details were provided about their health.
- The STOP NOP Association says that the control group in Gardasil trials received an aluminum adjuvant or another vaccine, making it difficult to assess safety reliably.
- Prof. Sucharit Bhakdi points out that little is known about where mRNA vaccines go in the body and how long they remain there, and that regulators have not made the data submitted by Pfizer publicly available.
What the authors write
Jerzy Zięba
Reports of serious side effects have not yet been presented in the results of ongoing clinical trials.
„On December 9, information about the first very serious side effects spread around the world, although these had not yet been presented in the results of ongoing clinical trials. Two people who received the first dose of the vaccine suffered anaphylactic shock.”9 grudnia świat obiegły informacje na temat pierwszych bardzo poważnych efektów ubocznych, których nie przedstawiono jak dotąd w wynikach trwających badań klinicznych.
U dwóch osób, które przyjęły pierwszą dawkę szczepionki wystąpił wstrząs anafilaktyczny.
Jerzy Zięba
Two people reportedly suffered anaphylactic shock after the first dose, and four developed Bell’s palsy; no further details were provided about their health.
„Two people who received the first dose of the vaccine suffered anaphylactic shock. Four volunteers developed Bell’s palsy. No further details are known about their health. This information was reported by the media. Below is a list of publications containing information about these side effects, to ensure that you have access to it.”U dwóch osób, które przyjęły pierwszą dawkę szczepionki wystąpił wstrząs anafilaktyczny. U 4 ochotników wystąpiło porażenie Bella. Nie są znane dodatkowe szczegóły dotyczące stanu ich zdrowia. Informacje te zostały podana przez media. Poniżej przedstawiam listę publikacji, w których znajdziecie informacje na temat tych efektów ubocznych by zapewnić Państwu dostęp do informacji.
Stowarzyszenie STOP NOP
In Gardasil trials, the control group received an aluminum adjuvant or another vaccine rather than an inert placebo, which, according to the author, makes it difficult to assess safety reliably.
„The most important clinical trials do not provide us with reliable information about safety. That is because, in the clinical trials used to authorize Gardasil, the control group did not receive saline (an inert placebo), but instead received active ingredients or another vaccine.”Najważniejsze badania kliniczne nie dostarczają nam wiarygodnych informacji na temat bezpieczeństwa. Bo w rejestracyjnych badaniach klinicznych Gardasilu kontrola nie była solą fizjologiczną (obojętnym placebo), tylko zawierała składniki aktywne lub inny szczepionkę.
Stowarzyszenie STOP NOP
The STOP NOP Association says that consent forms described the placebo as saline or an inactive substance, although it was supposed to contain an active aluminum adjuvant.
„“Promotional materials for the study and informed consent forms stated that the placebo was saline or an inactive substance, whereas in fact it contained a highly reactogenic aluminum adjuvant developed by Merck, whose safety, it would appear, was not properly assessed.”
https://journals.sagepub.com/doi/10.3233/JRS-230032#ref121
Other potential mechanisms contributing to side effects after Gardasil
https://pubmed.ncbi.nlm.nih.gov/31593963/
https://sanevax.org/wp-content/uploads/2019/07/Editorial-censorship-TLR9-agonist-in-Gardasil9.pdf
On what basis, then, is Gardasil said to be safe?”„Materiały reklamowe dotyczące badania oraz formularze świadomej zgody wskazywały, że placebo stanowi sól fizjologiczna lub substancja nieaktywna, podczas gdy w rzeczywistości zawierało ono opracowany przez firmę Merck, wysoce reaktogenny adiuwant glinowy, którego bezpieczeństwo – jak się wydaje – nie zostało właściwie ocenione.”
https://journals.sagepub.com/doi/10.3233/JRS-230032#ref121
Inne, potencjalne mechanizmy przyczyniające się do skutków ubocznych po Gardasilu
https://pubmed.ncbi.nlm.nih.gov/31593963/
https://sanevax.org/wp-content/uploads/2019/07/Editorial-censorship-TLR9-agonist-in-Gardasil9.pdf
To na jakiej podstawie twierdzi się, że Gardasil jest bezpieczny?
Prof. Sucharit Bhakdi
According to the author, little is known about where mRNA vaccines go in the body and how long they remain there; regulators have not made the data submitted by Pfizer publicly available.
„Because of the officially sanctioned haste and systematic gross negligence in the development and approval of the COVID-19 vaccines, our knowledge of their pharmacokinetics is sketchy. The only somewhat detailed animal study that has reached the public pertains to the Pfizer vaccine [1, 2].”Because of the officially sanctioned haste and systematic gross negligence in the development and approval of the COVID-19 vaccines, our knowledge of their pharmacokinetics is sketchy. The only somewhat detailed animal study that has reached the public pertains to the Pfizer vaccine [1, 2].
Jerzy Zięba
The manufacturer itself analyzes the clinical trial results and prepares the statistics, without independent verification by external institutions.
„The problem, however, is that after the clinical trial data have been collected, the manufacturer itself analyzes them and prepares the statistical data. It uses only its own laboratories and, in a completely uncontrolled manner, without any independent verification or assessment by any other external institutions, submits this information to the FDA to obtain authorization to market the drug.”Problem jednak polega na tym, że po zebraniu danych wyniku testów klinicznych, sam producent przeprowadza ich analizę, opracowuje dane statystyczne, korzysta tylko z własnych laboratoriów i w sposób zupełnie niekontrolowany, bez żadnej niezależnej weryfikacji, nie oceniany przez jakiekolwiek inne ośrodki zewnętrzne, przekazuje te informacje do FDA w celu uzyskania zezwolenia na wprowadzenie tego leku do obrotu.
Piotr Witczak
Piotr Witczak believes that studies said to disprove a link between vaccines, mercury, and autism are of low quality and that their authors have conflicts of interest.
„It should therefore come as no surprise that studies said to disprove a link between vaccines, mercury, and autism are of low quality, their authors have conflicts of interest, and their conclusions are politically correct [45][46][47]. This is not the first time medicine has been wrong.”Nie powinno zatem dziwić, że badania rzekomo obalające związek między szczepionkami, rtęcią a autyzmem są niskiej jakości, autorzy mają konflikty interesów a wnioski poprawne politycznie[45][46][47]. To nie pierwszy raz, kiedy medycyna jest w błędzie.
Jerzy Zięba
Jerzy Zięba claims that the flu vaccine does not undergo clinical trials.
„The flu vaccine, so eagerly given to everyone who wants it, including pregnant women, does not undergo any clinical trials, not even on the proverbial dog. You can see the evidence here:
https://www.bitchute.com/video/hpWNuh0wj9Mu/ It has been shown that giving a pregnant woman a flu vaccine is associated with an increase of more than 700% in the risk of having a child with autism and schizophrenia.”Tak ochoczo podawana wszystkim chętnym, łącznie z kobietami w ciąży, szczepionka przeciw grypie nie przechodzi przez żadne badania kliniczne, nawet na przysłowiowym psie. Dowód macie Państwo tutaj:
https://www.bitchute.com/video/hpWNuh0wj9Mu/ Wykazano, że podanie kobiecie w ciąży szczepionki przeciw grypie, łączy się ze zwiększeniem o ponad 700% ryzyka urodzenia dziecka autystycznego i ze schizofrenią.
Jerzy Zięba
Jerzy Zięba claims that no vaccine has passed trials meeting the so-called gold standard.
„It is well known that no vaccine has ever undergone clinical trials meeting these standards! None!
Marketing any substance classified as a medicinal product in Poland without it having undergone any clinical trials, however small, would certainly be illegal.”Wiadomo, że żadna szczepionka nigdy nie przeszła przez badania kliniczne spełniające te standardy! Żadna!
Wprowadzenie do obrotu w Polsce jakiejkolwiek substancji zaklasyfikowanej jako lek, który nie przeszedł przez jakiekolwiek, najmniejsze nawet testy kliniczne, z pewnością byłoby nielegalne.
Jerzy Zięba
Jerzy Zięba cites a report claiming that flu vaccination during pregnancy is associated with an increased risk of autism and schizophrenia in the child.
„You can see the evidence here:
https://www.bitchute.com/video/hpWNuh0wj9Mu/ It has been shown that giving a pregnant woman a flu vaccine is associated with an increase of more than 700% in the risk of having a child with autism and schizophrenia. But all of this pales in comparison with the fact that in Poland, doctors give the hepatitis B vaccine to babies weighing as little as 600 g at birth, after which the babies die immediately.”Dowód macie Państwo tutaj:
https://www.bitchute.com/video/hpWNuh0wj9Mu/ Wykazano, że podanie kobiecie w ciąży szczepionki przeciw grypie, łączy się ze zwiększeniem o ponad 700% ryzyka urodzenia dziecka autystycznego i ze schizofrenią. To wszystko jednak blednie w świetle tego, że w Polsce, lekarze podają szczepionkę WZW B dzieciom nawet o wadze urodzeniowej 600 g, po czym dzieci natychmiast umierają.
Research from PubMed · Europe PMC
We selected 5 studies with the best, positive results. This is a selection, not a full review of all research.
Total number of studies on this topic in PubMed: 10 439.
Studies on cataracts published positive results far more often than negative ones.
Aim of the study: Evidence-based decision-making is generally based on published evidence. Therefore, if the published evidence is biased, so will the decision-making.
Results: Of the 132 trials included, there were 69 positive and 63 negative results. Publication rate for positive results (71%) was significantly greater than negative results (17%) ( P < .01), with no significant difference in the other publication metrics. In conclusion, "negative" result trials are published less frequently, but are equally valued, if published. There are implications for evidence-based medicine with these findings.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studyobservation of people
“Not stated” does not mean nobody paid — the database does not always record it.
In studies of upper gastrointestinal cancers, statistically significant results were published more often than non-significant results.
Aim of the study: Evidence-based medicine requires evaluation of the medical literature to guide clinical reasoning and treatment recommendations. The presence of publication bias towards exclusion of non-statistically significant clinical trials may be leading to an incomplete evaluation of the literature and cause potentially incomplete guidance for patients.
Results: In total, 535 clinical trials were examined, across all pathologies clinical trials with significant findings for the primary outcome were published at a higher rate (99%) compared to those with non-significant findings (77%) (p < 0.01). Significantly, more studies with significant findings reached at least 80% of their estimated enrollment goal versus non-significant studies, 72% and 53% respectively (p < 0.01). Three of four metrics for impact of publication showed no difference between significant and non-significant studies once they reached publication. These findings suggest that clinical trials of three of the most common upper gastrointestinal malignancies have a publication bias towards studies with significant primary outcome findings. This study has implications to the way evidence-based medicine is practiced as the medical literature appears to be failing to capture important data for consideration of clinical decision making.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studyobservation of people
“Not stated” does not mean nobody paid — the database does not always record it.
In a review of rehabilitation studies, only 13% of registered protocols were published, and the agreement between primary outcomes and the protocol was 48.7%.
Aim of the study: To investigate the rate of registered protocols published as research papers as a measure of publication bias, and the concordance rates of the primary outcomes between research protocol and published papers as a measure of selective outcome reporting bias in randomized controlled trials (RCTs) related to rehabilitation.
Results: This study revealed major discrepancies between the number of research protocols and published papers, and difference of description regarding the primary outcomes in published papers which were already defined in the research protocols.
Money for the studynot stated
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studyreview of many studies
“Not stated” does not mean nobody paid — the database does not always record it.
More than a quarter of registered studies remained unpublished even after 10–14 years.
Aim of the study: Timely publication of clinical trials is critical to ensure the dissemination and implementation of high-quality healthcare evidence. This study investigates the publication rate and time to publication of randomized controlled trials (RCTs) registered in the Australian New Zealand Clinical Trials Registry (ANZCTR).
Results: Of 1,970 trial registrations, 541 (27%) remained unpublished 10 to 14 years later, and the proportion of trials published decreased by 7% from 2007 to 2011. The average time to publish was 4.63 years. The prospective trial registration rate for 2007, 2009 and 2011 was 48% (952 trials) and over this time there was an increase of 19% (280 prospective trials). Trials funded by non-Industry organizations were more likely to be published (74%, 1204/1625 trials) than the industry-funded trials (61%, 224/345 trials). Larger trials with at least 1000 participants were published at a rate of 88% (85/97 trials) and on average took 5.4 years to be published. Smaller trials with less than 100 participants were published at a lower rate with 67% (687/1024 trials) published and these trials took 4.31 years on average to publish. Just over a quarter of all trials on the ANZCTR for 2007, 2009, and 2011 remain unpublished over a decade later.
Money for the studynot stated
Do the authors have ties to companies?no — the authors say so
Did a manufacturer help with the study?NO
Type of studyobservation of people
“Not stated” does not mean nobody paid — the database does not always record it.
Studies with results considered significant were published far more often than those with non-significant results.
Aim of the study: To investigate the association between trial characteristics, findings, and publication. The major factor hypothesized to be associated with publication was "significant" results, which included both statistically significant results and results assessed by the investigators to be qualitatively significant, when statistical testing was not done.
Results: Of the 198 clinical trials completed by 1988, 93% had been published. Trials with "significant" results were more likely to be published than those showing "nonsignificant" results (adjusted odds ratio [OR] = 12.30; 95% confidence interval [CI], 2.54 to 60.00). No other factor was positively associated with publication. Most unpublished trials remained so because investigators thought the results were "not interesting" or they "did not have enough time" (42.8%). Metaanalysis using data from this and 3 similar studies provided a combined unadjusted OR of 2.88 (95% CI, 2.13 to 3.89) for the association between significant results and publication. Even when the overall publication rate is high, such as for trials funded by the NIH, publication bias remains a significant problem.
Money for the studygovernment, public institutions · AHRQ, HHS
Do the authors have ties to companies?not stated
Did a manufacturer help with the study?unknown
Type of studycombined analysis of many studies (meta-analysis)
“Not stated” does not mean nobody paid — the database does not always record it.
Perspectives and opinion materials
The content below presents the authors’ opinions, interpretations and hypotheses. It is not treated as equal to scientific studies and systematic reviews.
Orthomolecular Medicine News Service Opinion material
„A third assumption, that vitamin D clinical trials should be based on measurements of 25(OH)D concentrations at baseline and during the trial, and that the 25(OH)D concentration-health outcome relationship should be used to guide participant selection and vitamin D dose -- will tend to bias the results. Some of the papers discussed in the present document point the way towards proper vitamin D clinical trials. Latest perspectives on optimal dose of vitamin D Michael Holick published another review of vitamin D that addressed some of the current controversies [Holick, 2017].”A third assumption, that vitamin D clinical trials should be based on measurements of 25(OH)D concentrations at baseline and during the trial, and that the 25(OH)D concentration-health outcome relationship should be used to guide participant selection and vitamin D dose -- will tend to bias the results. Some of the papers discussed in the present document point the way towards proper vitamin D clinical trials. Latest perspectives on optimal dose of vitamin D Michael Holick published another review of vitamin D that addressed some of the current controversies [Holick, 2017].
Orthomolecular Medicine News Service Opinion material
„Why Many Vitamin D RCTs Fail: Lessons from Henry Lahore Henry Lahore has compiled a detailed list of 19 recurring design flaws that tend to bias vitamin D trials toward null outcomes [42]. Below is a condensed and thematically organized version (with adjustments to integrate into this article's narrative): Fixed dosing without personalization. Trials seldom allow dose adjustments to account for age, obesity, gut absorption issues, genetic variability (e.g. low vitamin D-binding gene function), drug interference (statins, etc.), or other comorbidities. Too short trial duration.”Why Many Vitamin D RCTs Fail: Lessons from Henry Lahore Henry Lahore has compiled a detailed list of 19 recurring design flaws that tend to bias vitamin D trials toward null outcomes [42]. Below is a condensed and thematically organized version (with adjustments to integrate into this article's narrative): Fixed dosing without personalization. Trials seldom allow dose adjustments to account for age, obesity, gut absorption issues, genetic variability (e.g. low vitamin D-binding gene function), drug interference (statins, etc.), or other comorbidities. Too short trial duration.
Orthomolecular Medicine News Service Opinion material
„Because young people generally experience fewer side effects, drugs will look safer." Another of the "common ways to bias trials is to present only part of the data - the part that makes the product look good - and ignore the rest." She adds, "The most dramatic form of bias is out-and-out suppression of negative results." (3) You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: "Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties" in 17 years.”Because young people generally experience fewer side effects, drugs will look safer." Another of the "common ways to bias trials is to present only part of the data - the part that makes the product look good - and ignore the rest." She adds, "The most dramatic form of bias is out-and-out suppression of negative results." (3) You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: "Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties" in 17 years.
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