DOI: https://doi.org/10.20529/IJME.2010.023
Fraud and misconduct have probably always existed in biomedical research and, as is evidenced by recent events, they are here to stay. Witness, for example, two recent cases, one in basic science from 2006, that of the Korean stem cell researcher Hwang Woo-Suk, and the other from clinical medicine in 2009 (after the book under review was published), that of Scott Reuben, the anaesthesia and pain researcher. Both of them published papers in leading journals in their field which changed the way we think about and practise science and medicine – until their fraud was detected. Thus, the authors begin the book with these appropriate words in the preface: “It is with some regret that a fourth edition of this book still has relevance today.”
Fraud and misconduct in biomedical research, in its earlier avatar (with the redoubtable Stephen Lock as one of the editors) has been acclaimed as a masterpiece and this edition, which is largely rewritten, is meant to be a textbook for dealing with fraud. In this, the editors of the book have succeeded. The six sections of the book deal with the basics of fraud (value systems, issues in publishing and a definition of misconduct), a review of the history of fraud in North America and Europe, the prevention of fraud, how to detect fraud, how to investigate it and, finally, the way ahead.
The book reiterates that fabrication, falsification, plagiarism and theft are the four cardinal examples of fraud. Much of this is to achieve fame, financial gain, promotions and at times, to use Stephen Lock’s term, because of a “Messiah complex”. However, our changing values and a changing society have dictated that many things which would once have been considered entirely acceptable are now looked upon entirely differently. Richard Smith, ex-editor of the BMJ, discusses some of these ethical issues that arise in publication. These include, among other things, failure to obtain informed consent for research, failure to publish (!) or publishing too much. Informed consent is perhaps the best known aspect of research ethics and needs no elaboration. But failure to publish, particularly if the results are negative, also constitutes misconduct. This is because, it is argued, it is the researchers’ duty to publish, and because negative results rarely get published, this can result in a bias in favour of a treatment – which would be unscientific. Journals nowadays insist on patient consent even for the publication of case reports. I must confess that I had never understood the logic of this, but Smith explains why the BMJ started asking for this – and I now see the logic of it. Yet, Smith himself admits that they sometimes felt they were going too far in this and thus, there are still many unanswered questions about the appropriateness of consent in all cases.
About one third of the book deals with the methods of detection of research misconduct – appropriate indeed for a textbook. The means of doing this are varied and at many levels – right from using the electronic media to identify fraud to the use of audits to the use of appropriate statistical analysis to unearth fraud. There are explanatory examples – but the authors do not divulge all details. Of course, it makes sound sense not to reveal your hidden strengths to the enemy. It is interesting to learn that most cases of misconduct are brought to light because of whistleblowers. Yet most of these whistleblowers – as seen in numerous anecdotes in the book – suffer financially, professionally and mentally after blowing the whistle. Other thought-provoking bits of information in the book were these: research fraud is not considered by many, it appears, as heinous as financial fraud; none of the 26 cases of fraud in the UK (p 73) are by women; and as recently as 2007, 41% of over 200 leading biomedical journals gave no instructions about authorship criteria.
Can this book be improved further, in the next edition, perhaps? My only wish, or perhaps grouse, is that the book is largely West-centric. It is, of course, entirely up to the editors to decide who they wish their target audience to be (European and American), but given that they intend this to be a text, I believe they should address a larger, global audience. Indeed, while the preface states that the contributors are “from all corners of the world”, I could only see contributors from Europe and the USA. Even the excellent histories of fraud are largely about cases from North America and Europe. Surely South America, Africa, Asia and Australia have also had their share of problems with fraud – and certainly, all of us could learn valuable lessons from these. Russia and India are now centres of clinical trials and ethical issues (and thereby issues dealing with misconduct) have arisen in a considerable number of trials.
It is of course well known that India, like many other developing nations, lacks a proper mechanism to check fraud. This has been discussed in some detail elsewhere (1). If the good guys are to stay ahead of the bad guys, they would do well to read this book and put the methods in it to good use.