Healthy Skepticism Library item: 2130

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Al-Marzouki S, Evans S, Marshall T, Roberts I.
Are these data real? Statistical methods for the detection of data fabrication in clinical trials
BMJ 2005 Jul 30; 331:(7511):267-70
http://bmj.bmjjournals.com/cgi/content/full/331/7511/267

Abstract:

OBJECTIVES: To test the application of statistical methods to detect data fabrication in a clinical trial.

SETTING: Data from two clinical trials: a trial of a dietary intervention for cardiovascular disease and a trial of a drug intervention for the same problem.

OUTCOME MEASURES: Baseline comparisons of means and variances of cardiovascular risk factors; digit preference overall and its pattern by group.

RESULTS: In the dietary intervention trial, variances for 16 of the 22 variables available at baseline were significantly different, and 10 significant differences were seen in means for these variables. Some of these P values were extraordinarily small. Distributions of the final recorded digit were significantly different between the intervention and the control group at baseline for 14/22 variables in the dietary trial. In the drug trial, only five variables were available, and no significant differences between the groups for baseline values in means or variances or digit preference were seen.

CONCLUSIONS: Several statistical features of the data from the dietary trial are so strongly suggestive of data fabrication that no other explanation is likely.

Keywords:
MeSH Terms: Adult Cardiovascular Diseases/prevention & control Chi-Square Distribution Clinical Trials/standards* Clinical Trials/statistics & numerical data Data Collection/standards* Data Collection/statistics & numerical data Data Interpretation, Statistical Diet Humans Middle Aged Multicenter Studies Random Allocation Randomized Controlled Trials/standards Scientific Misconduct/statistics & numerical data*

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909