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疫苗研究中结果报告偏倚的实例:说明延续医学共识如何阻碍公共卫生进展。

Examples of Outcome Reporting Bias in Vaccine Studies: Illustrating How Perpetuating Medical Consensus Can Impede Progress in Public Health.

作者信息

Goldman Gary S

机构信息

Research, Independent Computer Scientist, Bogue Chitto, USA.

出版信息

Cureus. 2022 Sep 21;14(9):e29399. doi: 10.7759/cureus.29399. eCollection 2022 Sep.

DOI:10.7759/cureus.29399
PMID:36304385
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9585808/
Abstract

INTRODUCTION

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.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/a041a61a13da/cureus-0014-00000029399-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/4fec95b43454/cureus-0014-00000029399-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/48380795a975/cureus-0014-00000029399-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/334ed0ae17cb/cureus-0014-00000029399-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/a041a61a13da/cureus-0014-00000029399-i04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/4fec95b43454/cureus-0014-00000029399-i01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/48380795a975/cureus-0014-00000029399-i02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/334ed0ae17cb/cureus-0014-00000029399-i03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/44ae/9585808/a041a61a13da/cureus-0014-00000029399-i04.jpg
摘要

引言

疫苗研究中的结果报告偏差是一个普遍存在的问题,所有研究人员都倾向于报告支持其自身信念、价值观或资助机构信念、价值观的选择性结果和结论。尤其是在新冠疫情期间,这种偏差通过相互矛盾的疫苗研究前所未有的大量涌现而暴露出来。许多研究人员大力推荐并报告新冠疫苗的安全性和有效性。那些总体上支持新冠疫苗及疫苗接种的研究人员,往往对其他提出与医学正统观点不同且反对医学共识观点的研究人员不屑一顾。

方法

本分析的目的是运用定性和/或定量方法对七项疫苗研究进行批判性评估,以识别结果报告偏差,并评估其对与医学共识相符的既定结论的潜在影响。四项研究声称未发现自闭症与(a)血液汞含量、(b)麻疹、腮腺炎和风疹(MMR)疫苗以及(c)含硫柳汞疫苗之间存在关联。另外三项研究声称婴儿死亡率与疫苗接种剂量数量、普遍水痘疫苗接种与带状疱疹以及大流行性流感疫苗与胎儿流产之间不存在关联。

结果

结果报告偏差的存在以及独立重新分析表明,这对观察到的效应的方向和大小都产生了影响——引发了对原始研究设计和结论稳健性的质疑,并对当前的医学共识提出了挑战。医学共识判定疫苗与自闭症谱系障碍(ASD)不存在因果关系,但尚未提出其他合理原因。医学共识将ASD病例显著增加归因于更好的病例确诊和更广泛的临床诊断。根据2018年的数据,估计每44名8岁儿童中就有1人被确诊患有ASD。从1990年到2019年,美国估计新增了200万例ASD病例,终生社会成本超过7万亿美元(按2019年美元计算)。延续医学共识会阻碍公共卫生的进步吗?还是它已经造成了阻碍?

结论

卫生监管机构与制药行业之间大量存在的利益冲突(如经济利益冲突)影响了最终被视为医学共识的内容。所有研究人员在某种程度上都固有的结果报告偏差掩盖了医学和科学真相。公共卫生的进步要求研究人员具备诚信,并且愿意开放合作以解决相互矛盾的研究结果。事实上,医学科学通常正是通过对相互矛盾的研究结果进行细致、严谨的科学调查才得以进步,并为改善公共卫生做出贡献——因为医学共识和正统观念可能是错误的。

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