A Reflection on Fraud and Misconduct in Biomedical Research
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EDITORIAL
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A Reflection on Fraud and Misconduct in Biomedical Research Frank Wells European Forum for Good Clinical Practice Ethics Working Party, Old Hadleigh, Ipswich, UK
Fraud and misconduct in biomedical research occurs all the time, and although certainly not rife, it occurs sufficiently frequently to raise real concerns, not least because it involves patient exploitation. Also, if undetected, it could lead to licensing decisions about medicines being based on false or fabricated data. So what is its prevalence? Well, as Thoreau famously said (or was it Copernicus?), ‘‘we do not know what we do not know’’ and can only estimate prevalence on what we do know. My own experience as a fraudbuster for over 20 years puts it at about 1% within all the clinical trials being conducted at any one time. However, publication irregularities are much more frequent, probably in the region of 5% of published research reports, which most certainly gives cause for concern. Pharmaceutical health workers will be aware that attitudes towards research have always been ambivalent and have always swung between extremes. Before scientific methodology was able to be proved, research projects were considered to be sorcery and quackery. Then came an uncritical acceptance or even reverence for science, particularly biomedical science or research. Now there is a far more critical approach to research reports and results, not least because of publicity given to horror stories in the newspapers and on television. Nevertheless, the idea that scientists might deliberately ‘cook the books’, fabricate data or even exploit patients for personal gain or other reasons is clearly cause for concern and this concern probably accounts for such behaviour not being common. But human nature being what it is, such behaviour will always be with us, though hopefully to a diminishing extent. I have to acknowledge that it is difficult to give an accurate account of the history of medical research misconduct before the last quarter of the 20th century, since little was written prior to this time. In Europe, however, there were a few notorious episodes before then that were well documented, including the existence of ‘philosophicall robbery’ or plagiarism, described as long ago as 1664 by Robert Boyle,[1] whose works were frequently plagiarized and pirated. In the field of psychology, after many years of controversy, it had been shown beyond a rea-
sonable doubt that Sir Cyril Burt committed fraud in his comparison of monozygotic twins.[2] And in the history of scientific fraud, remember 1913 and the discovery of a human skull next to an ape’s jaw with a canine tooth worn down like a human’s. The general community of British paleoanthropologists came to accept the idea that the fossil remains belonged to a single creature that had a human cranium and an ape’s jaw. But 40 years later, Piltdown ‘man’ was exposed as a forgery. The skull was modern and the teeth on the ape’s jaw had been filed down. Returning t
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