Randomized Clinical Trial Is Biased and Invalid In Studying Chronic Diseases, Compared with Multiple Factors Optimization Trial

Wu, Jianqing; Zha, Ping

doi:10.2139/ssrn.3480523

Cited by 18 publications

(68 citation statements)

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“…In our prior study, we found that controlled trials are improper methods for studying weak health factors when many interfering factors (equivalent to covariates in statistics) normally exist in clinical trials [9]. Our findings support the conclusions that all controlled clinical trials are biased [10].…”

Section: Introductionsupporting

confidence: 83%

“…When the validity of controlled trials is under challenge, we give more weights to those sources of evidence. Based on our prior studies [9], we ignore negative findings from controlled trials directed to weak factors.…”

Section: Methodsmentioning

confidence: 99%

“…To understand how weak factors affect disease outcomes, we need to examine biological pathways and disease-controlling mechanisms. We have shown that randomized controlled trials do not have the power to overcome sensitivity limits [9]. This insufficient-accuracy problem cannot be seen from the outcomes of clinical trials.…”

Section: Introductionmentioning

confidence: 93%

“…If a weak factor is studied in a clinical trial, it is improperly rejected as experimental errors. Most assumptions used in clinical trials and statistical analysis have not been considered [9].…”

Section: Introductionmentioning

confidence: 99%

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Clinical Trials and Reductionist Approach Preclude Cures for Chronic Diseases Due to Flawed Presumptions

Wu¹,

Zha²

2020

Preprint

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Modern medicine adopted four presumptions when it evolved from ancient experienced-based mind-body medicine. To understand its failure in finding cures for chronic diseases, we examined four presumptions, and found that statistical population of health properties does not exist for most research purposes, mathematical models are misused to model intensive properties, synthetic drugs are inherently more dangerous than nature-made medicines under their respective application conditions, and reductionist treatments are inferior and inherently dangerous. We found that clinical trials are valid only for research where treatment effect is much stronger than the total effects of all interfering or co-causal factors or errors introduced by misused mathematical models can be tolerated. In all other situations, clinical trials introduce excessive errors and fail to detect treatment effects, or produce biased, incorrect or wrong results. We further found that chronic diseases are manifestation of small departures in multiple process attributes in distinctive personal biological pathways networks, that modern medicine lacks required accuracy for accurately characterizing chronic diseases, and that reductionist treatments are good at controlling symptoms and safe for short term uses. For all stated reasons, as long as modern medicine continues relying on the flawed presumptions, it can never find predictable cures for chronic diseases. By implication, predictable cures to chronic diseases are adjustments to lifestyle, dietary, emotional, and environmental factors to slowly correct departures in process attributes responsible for chronic diseases.

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Section: Introductionsupporting

confidence: 83%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 93%

Section: Introductionmentioning

confidence: 99%

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Clinical Trials and Reductionist Approach Preclude Cures for Chronic Diseases Due to Flawed Presumptions

Wu¹,

Zha²

2020

Preprint

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“…The total inner surface area is about 70-100 m 2 . Each alveolus may be made of 40 type I cells and 77 type II cells [31]. So, the lungs have about 70 billion epithelial cells that are exposed to the internal air way.…”

Section: Vulnerability Of Lungs To Viral Attacksmentioning

confidence: 99%

Mask Is a Double-edged Sword in the Fight Against COVID-19 Pandemic

Wu¹,

Zha²

2020

SSRN Journal

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The COVID-19 pandemic has become out of control. To determine whether the lack of protection of lungs is a factor for the rapidly increasing infected population, we constructed a mask use model and analyzed how viral particles behavior. We found that mask can prevent viral particles from crossing it, reduce oxygen uptake efficiency, raise inlet air temperature, and increase resistance to breathing. We found that uninfected people should wear masks in any closed public building where viral particles from infected persons are expected to exist; that masks can dramatically aggravate disease severity on infected persons; that use of masks by infected persons is justified only if cross-infection and successive infections from external viral sources outweigh the expected harm; that people with unknown infection status should exercise due care. We further found at this point no fast measure can break the chain of infection, social distancing rule is insufficient, and wearing masks is the only effective remedy for interim protection. We found that World Health Organization's rules on the use of masks are largely incorrect, and so are the rules of the Centers for Disease Control and Prevention in the U.S. We predicted that those rules have dramatically increased severe infection incidence rate, and have made COVID disease of infected persons much severer. We personally noted that a big percent of Americans still do not wear masks in closed public areas, and leave the most lethal transmission route open. If masks are not correctly used, the U.S. and many Western nations © All right reserved, Wu & Zha v100 1 will sustain the worst damages in all aspects from human life and economic activities.

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FDA Should Re-evaluate All mRNA Vaccines and Revoke Their Use Authorizations (The Short Version).

Wu¹

2022

IJCV

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Drug industry, controlling medical publishers and large media promote flawed medicine for their revenues by systematically laundering medical knowledge in decades. They maintain and promote flawed research models and suppress disruptive discoveries, thereby precluding reform of medicine. In this study, I will deeply explore how the wrong life model, population-based research model, misused clinical trials, flawed statistical models, the symptom based research methods, binary disease classification, failure to address the massive vital organ capacities, failure to correct biases caused by expected delay in realizing side effects, and failure to address the interference effects of non-controllable factors affect the conclusions of “effectiveness and safety” for mRNA vaccines. I will directly analyze three studies that have been relied upon by FDA in approving mNRA use authorizations: one BNT162b2 effectiveness study published in NEJM, one booster shot study published in NEJM and a Seven Integrated Health Care Organizations study published by CDC. I will expose fatal flaws in the frequency risk concept, effectiveness rate, and hazard reduction ratios, and show why 3% death rate, 95% effectiveness rate and 90% mortality reduction are all meaningless and misleading, and should never have been used as treatment guidance. I will also examine common biases that can be easily practiced by sponsors’ researchers to alter conclusions in favor of approval. By relying on laundered medical “knowledge”, FDA has consistently failed to predict latent drug side effects for any drugs and vaccines in its history. FDA approved disastrous DES in 1941, Swine Flu vaccine in 1976, and mRNA vaccines in 2020. The vaccines are used to deliver short-term benefits on a small percent of persons at the costs of damaging health, causing deaths that could be avoided, and shortening lifespans for all people in the population. I thus urge FDA to reevaluate all mRNA vaccines and revoke their use authorizations.

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Randomized Clinical Trial Is Biased and Invalid In Studying Chronic Diseases, Compared with Multiple Factors Optimization Trial

Cited by 18 publications

References 0 publications

<b>Clinical Trials and Reductionist Approach Preclude Cures for Chronic Diseases </b><b>Due to Flawed </b><b>Presumptions</b>

<b>Clinical Trials and Reductionist Approach Preclude Cures for Chronic Diseases </b><b>Due to Flawed </b><b>Presumptions</b>

Mask Is a Double-edged Sword in the Fight Against COVID-19 Pandemic

FDA Should Re-evaluate All mRNA Vaccines and Revoke Their Use Authorizations (The Short Version).

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