PDF(Pubmed)
Abstract：
BACKGROUND: Outcome reporting bias in vaccine studies is a widespread problem among all researchers who have a tendency to report selective results and conclusions that support their beliefs and values or those of sponsoring agencies. Especially during the COVID-19 pandemic, this bias surfaced through the unprecedented proliferation of conflicting vaccine studies. Many researchers strongly recommend and report on the safety and effectiveness of the COVID-19 vaccine. Those researchers who embrace the COVID-19 vaccine and vaccines, in general, are often dismissive of other researchers who present views that differ from medical orthodoxy and oppose medical consensus.
METHODS: The aim of this analysis is to critically evaluate seven vaccine studies using qualitative and/or quantitative approaches to identify outcome reporting bias and assess its potential impact on the stated conclusions that align with medical consensus. Four studies claim to have found no association between autism and (a) blood levels of mercury, (b) measles, mumps, and rubella (MMR) vaccine, and (c) thimerosal-containing vaccines. Three other studies claim no association exists between infant mortality rate and the number of vaccine doses, universal varicella vaccination and herpes zoster, and pandemic influenza vaccines and fetal losses.
RESULTS: The presence of outcome reporting bias and independent reanalysis demonstrated an impact on both the direction and magnitude of the observed effect - raising questions concerning the robustness of the original study design and conclusions and challenging the current medical consensus. Medical consensus has exonerated vaccines as having any causal relationship to autism spectrum disorders (ASDs), yet no other reasonable cause has been proposed. Medical consensus attributes significant ASD increases to better case ascertainment and broadened clinical diagnosis. According to 2018 data, an estimated 1 in 44 eight-year-olds has been identified with ASD. From 1990 to 2019, there have been an estimated two million new cases of ASD in the US, with lifetime social costs exceeding $7 trillion (in 2019 dollars). Can perpetuating medical consensus impede the advancement of public health? Or has it already done so?
CONCLUSIONS: Conflicts of interest (e.g., financial) that abound between health regulatory agencies and the pharmaceutical industry impact what is ultimately reckoned as medical consensus. Outcome reporting bias that is inherent to all researchers to some degree, obscures medical and scientific truth. Advancement of public health requires that researchers have integrity and an openness and willingness to collaborate to resolve contradictory findings. In fact, it is usually through meticulous, rigorous, scientific investigation of contradictory findings that medical science has advanced and contributed to improvements in public health - since medical consensus and orthodoxy can be incorrect.
METHODS: The aim of this analysis is to critically evaluate seven vaccine studies using qualitative and/or quantitative approaches to identify outcome reporting bias and assess its potential impact on the stated conclusions that align with medical consensus. Four studies claim to have found no association between autism and (a) blood levels of mercury, (b) measles, mumps, and rubella (MMR) vaccine, and (c) thimerosal-containing vaccines. Three other studies claim no association exists between infant mortality rate and the number of vaccine doses, universal varicella vaccination and herpes zoster, and pandemic influenza vaccines and fetal losses.
RESULTS: The presence of outcome reporting bias and independent reanalysis demonstrated an impact on both the direction and magnitude of the observed effect - raising questions concerning the robustness of the original study design and conclusions and challenging the current medical consensus. Medical consensus has exonerated vaccines as having any causal relationship to autism spectrum disorders (ASDs), yet no other reasonable cause has been proposed. Medical consensus attributes significant ASD increases to better case ascertainment and broadened clinical diagnosis. According to 2018 data, an estimated 1 in 44 eight-year-olds has been identified with ASD. From 1990 to 2019, there have been an estimated two million new cases of ASD in the US, with lifetime social costs exceeding $7 trillion (in 2019 dollars). Can perpetuating medical consensus impede the advancement of public health? Or has it already done so?
CONCLUSIONS: Conflicts of interest (e.g., financial) that abound between health regulatory agencies and the pharmaceutical industry impact what is ultimately reckoned as medical consensus. Outcome reporting bias that is inherent to all researchers to some degree, obscures medical and scientific truth. Advancement of public health requires that researchers have integrity and an openness and willingness to collaborate to resolve contradictory findings. In fact, it is usually through meticulous, rigorous, scientific investigation of contradictory findings that medical science has advanced and contributed to improvements in public health - since medical consensus and orthodoxy can be incorrect.
摘要：
背景：结果报告疫苗研究中的偏倚是所有研究人员中普遍存在的问题，他们倾向于报告支持他们的信念和价值观或赞助机构的选择性结果和结论。特别是在COVID-19大流行期间，这种偏见通过前所未有的相互矛盾的疫苗研究而浮出水面。许多研究人员强烈建议并报告了COVID-19疫苗的安全性和有效性。那些接受COVID-19疫苗和疫苗的研究人员，总的来说,通常对其他提出不同于医学正统观念并反对医学共识的观点的研究人员不屑一顾。
方法：本分析的目的是使用定性和/或定量方法严格评估七项疫苗研究，以确定结果报告偏倚，并评估其对符合医学共识的既定结论的潜在影响。四项研究声称发现自闭症与（a）血液汞水平之间没有关联，(b)麻疹，腮腺炎,风疹（MMR）疫苗，和(c)含硫柳汞的疫苗。另外三项研究声称婴儿死亡率和疫苗剂量之间没有关联，通用水痘疫苗接种和带状疱疹，以及大流行性流感疫苗和胎儿损失。
结果：结果报告偏倚和独立再分析的存在证明了对观察到的效应的方向和大小的影响-提出了关于原始研究设计和结论的稳健性的问题，并挑战了当前的医学共识。医学共识证明疫苗与自闭症谱系障碍（ASD）有任何因果关系，然而，没有提出其他合理的理由。医学共识将ASD的显着增加归因于更好的病例确定和扩大的临床诊断。根据2018年的数据，据估计，44名8岁儿童中有1名患有ASD。从1990年到2019年，美国估计有200万新的ASD病例。终身社会成本超过7万亿美元(2019年美元)。维持医学共识会阻碍公共卫生的发展吗？还是已经这样做了？
结论：利益冲突（例如，金融)，卫生监管机构和制药业之间比比皆是，这影响了最终被认为是医学共识的东西。结果报告偏见在某种程度上是所有研究人员固有的，掩盖了医学和科学真理。公共卫生的进步要求研究人员具有诚信，开放和愿意合作解决矛盾的发现。事实上,它通常是通过细致，严谨,科学调查矛盾的发现，医学科学已经进步，并有助于改善公共健康-因为医学共识和正统观念可能是不正确的。
方法：本分析的目的是使用定性和/或定量方法严格评估七项疫苗研究，以确定结果报告偏倚，并评估其对符合医学共识的既定结论的潜在影响。四项研究声称发现自闭症与（a）血液汞水平之间没有关联，(b)麻疹，腮腺炎,风疹（MMR）疫苗，和(c)含硫柳汞的疫苗。另外三项研究声称婴儿死亡率和疫苗剂量之间没有关联，通用水痘疫苗接种和带状疱疹，以及大流行性流感疫苗和胎儿损失。
结果：结果报告偏倚和独立再分析的存在证明了对观察到的效应的方向和大小的影响-提出了关于原始研究设计和结论的稳健性的问题，并挑战了当前的医学共识。医学共识证明疫苗与自闭症谱系障碍（ASD）有任何因果关系，然而，没有提出其他合理的理由。医学共识将ASD的显着增加归因于更好的病例确定和扩大的临床诊断。根据2018年的数据，据估计，44名8岁儿童中有1名患有ASD。从1990年到2019年，美国估计有200万新的ASD病例。终身社会成本超过7万亿美元(2019年美元)。维持医学共识会阻碍公共卫生的发展吗？还是已经这样做了？
结论：利益冲突（例如，金融)，卫生监管机构和制药业之间比比皆是，这影响了最终被认为是医学共识的东西。结果报告偏见在某种程度上是所有研究人员固有的，掩盖了医学和科学真理。公共卫生的进步要求研究人员具有诚信，开放和愿意合作解决矛盾的发现。事实上,它通常是通过细致，严谨,科学调查矛盾的发现，医学科学已经进步，并有助于改善公共健康-因为医学共识和正统观念可能是不正确的。
