Revaluation of Drug with Abnormal Behavior,and Medical statistical-ethics, etc

来源 :第十二次全国医学遗传学学术会议 | 被引量 : 0次 | 上传用户:game780
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  Objectives Under the condition of great asymmetry in medical information, we predicted there were serious problems with famous antiplatelet clopidogrels core data from the analysis of its abnormal behaviors after its launch.We hoped to find direct evidence that core data of phase Ⅲ CAPRIE trial of clopidogrel must be wrong according to the forecast and deduction on the basis of behavioral economics, and that it was noise trading and effect of herd behavior, instead of practical therapeutic effect that made anti-platelet clopidogrel the globals second-largest selling lemon drug, and we hope that our findings will be helpful for families and the society to reduce high expenditure on medical treatment, revising medical statistical theory from the impeccable negative example, and building new disciplines such as medical statistical-ethics, medical-behavioral economics, etc.Methods Based on methodology of phase Ⅲ CAPRIE trial, we studied the core data of CAPRIE trials results by philosophy, logistics and statistics.Results In the table 6 of CAPRIE study, all of the data of fatal events between the fourth and fifth subgroup (Clopidogrel , No.4 subgroup: No.5 subgroup=490∶560; Aspirin, No.4∶No.5 =487∶571), between the second and third subgroup (Clopidogrel, No.2∶ No.3 =302∶350; Aspirin, No.2∶ No.3 subgroup =314∶378), between the first and second subgroup (Clopidogrel, No.1∶ No.2 =308∶302; Aspirin, No.1∶ No.2 =321∶314) were unbalanced or wrong.Conclusions The statistical data and analysis of the CAPRIE study were wrong and distorted.The results of CAPRIE were distorted or false and couldnt demonstrate that clopidogrel was superior to aspirin.Statisticaly significant(p=0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% CI 0.3-16.5) came from the virtual world.Revaluation of clopidogrel would reduce the unnecessary burden on family and society and maybe save several billion dollars every year.We suggested modifying guidelines for clopidogrel administration, revising medical statistical theory based on sample size and statistical power from the impeccable negative example.Ethics should be introduced in standardizing and intensifying the statistical analysis of the future clinical trials, and it seems necessary to establish the medical statistical-ethics, a specialized subject to strengthen the ethics education for medicine and statistics personnel.We also suggested building new disciplines such as medical-behavioral economics, pharmaco-behavioral economics, healthy-behavioral economics etc.It also reflected the urgent need for FDA to strengthen the process management and results review of the drugs phase Ⅲ trials.
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