Soman was an assistant professor of medicine at the Yale School of Medicine, who plagiarised parts of a manuscript sent in 1978 by the New England Journal of Medicine for peer review to his boss, Philip Felig, who passed the job on to him. Subsequently Soman and Felig published an article on the same topic, insulin binding in anorexia nervosa, in the American Journal of Medicine. Accused of plagiarism and conflict of interest, Felig seemed to settle the difficulties by stating that the work had been completed before they had received the paper for review. But its author, Dr Helena Wachslicht-Rodbard, a young researcher at the National Institutes of Health (NIH), who during this episode was to switch to hospital practice, persisted with her complaints. An inquiry by Dr Jeffrey Flier, a Boston diabetologist, in February 1980 showed that these were justified. Not only had Soman copied her manuscript, but most of the data in his own joint study had been faked. A subsequent investigation soon after found that, of 14 articles, only two could be approved, and the data were either missing or fraudulent in the remaining 12 (10 of them with Felig as co-author). All these articles were retracted by Felig.
This case is important as it highlighted several themes that were to feature strongly in subsequent cases. Firstly, there was an abuse of editorial peer review. This was something that had often featured as anecdotal accusations by angry authors in the past but had rarely been documented (though it has occurred again since this episode). Secondly, there was the involvement of a distinguished figure as a "gift" author, who had put his name to work with which he had not been associated - indeed, he could not have been because the work had not been done and the results were invented. Thus the episode was a personal tragedy for Felig, who resigned from a prestigious post at Columbia University, to which he had been appointed while the episode was unfolding. Thirdly, in these early days the authorities did not know how to react. They were hesitant about instigating a full and proper inquiry into an accusation made against a senior figure, and only Wachslicht-Roadbard's persistence brought about the disclosures.
Darsee was a Harvard research worker in cardiology, who was seen to falsify data during a laboratory study. His overall head of department, the distinguished cardiologist Eugene Braunwald, decided that this was a single bizarre act and allowed him to continue to work under close supervision, but terminated his NIH fellowship. Six months later, however, it became clear that Darsee's data in a multicentre study of treatments to protect the ischaemic myocardium were different from those at the three other units taking part. Harvard Medical School set up a committee of investigation, as did the NIH and Emory University, where Darsee had also worked. It emerged that Darsee had committed an extensive series of frauds, originating in his undergraduate days at Notre Dame University and continuing at Emory and Harvard. These included non-existent patients or collaborators, and invented data, as in the multicentre trial. There were also procedures and results that on reflection were virtually impossible: drawing blood from the tail veins of 200 rats weekly for all of their 90-week lifespan, and obtaining venous blood specimens (including from a 2-year-old child). In all, during his career Darsee published over 100 papers and abstracts, many of them in prestigious journals and with distinguished co-authors; many of them had to be retracted.
Possibly until recently, more ink has been shed on Darsee's case than on any other. In part, this was because it was the first major publicised case that was not an isolated blemish on the face of science (not mad - rather, bad); in part, because it concerned prestigious institutions, co-authors, and journals; in part, because of the charismatic personality of one of the central figures; in part, because it started the whole debate about the rights and wrongs of authorship (particularly gift authorship), data retention, the supervision of juniors, and the management of suspected cases of fraud. There was also the realisation of the pressure to publish - and not merely important work but anything that showed a department's activity, though the results should somehow be positive. Finally, the case also shifted the whole climate of feeling of trust to thinking the unthinkable - the possibility that things might not be as they seemed. There was also the new concept: once a crook, often always a crook - Darsee was found to have had a long history of faking his results in different projects and in different settings.
All these ramifications are ably explored in Marcel LaFollette's book,13 and also in her revised article in this volume (Chapter 3). A particularly cogent account of why Darsee was trusted in the conditions prevailing at the time was provided by his former mentor, Eugene Braunwald.15 This episode also shows the inadequacy of editorial peer review for detecting fraud (although two workers at the NIH were subsequently to demonstrate some egregious errors in Darsee's papers16), as well as the role of attempts by other workers to replicate results in revealing its existence.
Unlike some other disciplines, such as chemistry or physics, a lack of replication is a feature of research in medicine, given that it is often complex and expensive, and there is little enthusiasm by peers for merely confirmatory work. Nevertheless, failure to replicate results has occasionally brought other medical research frauds to light, as in the case of Claudio Milanese, an Italian immunologist who had claimed that IL-4A, a lymphokine, induced interleukin-2 receptors.17 Later research showed that IL-4A did not exist. Finally, subsequent research showed the depressing result that, although Darsee's articles had been retracted from the literature - and that this fact was reflected in the electronic databases - these were still being cited in the literature, not in articles on research fraud but as references in papers on the very topic with which Darsee's fraudulent research had allegedly been concerned.18
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