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Fraud, Errors and Gamesmanship in Experimental Toxicologyଝ

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Fraud, Errors and Gamesmanship in Experimental Toxicologyଝ Toxicology 202 (2004) 1–20 Fraud, errors and gamesmanship in experimental toxicologyଝ Iain F.H. Purchase∗ University of Manchester, Oxford Road, Manchester M13 9PT, UK Available online 3 August 2004 Abstract We expect moral behaviour from scientists. Morality implies being a good person and being good at one’s profession. The general view appears to be that the vast majority of scientists aim to achieve these high standards. Science prides itself on the ‘self-correcting’ mechanism in the scientific method, namely the requirement to reproduce findings before they are taken seriously. However, when findings are related to the adverse effects of chemicals there are several features that make this less effective than in some other fields of science. First, is the perception that everyone is exposed to chemicals and observations about chemical danger are immediately applicable to many people. Second, it is often easy to summarize adverse findings in attention-getting headlines seen by the lay public before the slow process of replication and interpretation has time to work. Third, most regulatory toxicology studies on a particular compound are only done once to minimise cost and the use of ani- mals. Finally, the question posed about chemicals – are they safe? – is easy to ask but more difficult to test with appropriate studies. Fabrication of data in regulatory studies was found to occur in several contract laboratories in the 1960s and this lead directly to the introduction of Good Laboratory Practice regulations. Now studies submitted for regulatory purposes must comply with GLP regulations and this has virtually eliminated flawed studies due to fraudulent or careless behaviour. It is possible to discern different ways in which the expected standards have not been met. The first is in the intention of the work. Thus reports that the Roodeplaats Research Laboratory in South Africa was seeking to identify toxins that would kill without trace is an example where the intention is unacceptable. The second is in the conduct of the studies. Here the examples of William McBride and Michael Briggs who falsified data are pertinent. The example of the retraction of reports on the toxicity of ecstasy because the wrong compound had been administered indicates a degree of carelessness in the conduct of the study. The third is in the design and interpretation of studies. The report that genetic modification per se could render potatoes toxic has been criticised because of the inappropriate design and interpretation of the studies. Finally, that the reports of studies are biased because of conflicts of interest. Journals often require a declaration that the author has no financial conflict of interest. However, there are many other conflicts of interest with just as large an impact on the author’s impartiality which are omitted from consideration. Gamesmanship has also entered the practice of toxicology, for example where strong assertions about conflict of interest are used to justify particular points of view. The main casualty from fraud, errors and gamesmanship is the perceived status of science itself. It is only gamesmanship that is on the increase. The remedies for these activities are explored. © 2004 Elsevier Ireland Ltd. All rights reserved. Keywords: Fraud; Errors; Gamesmanship ଝ PATON prize award lecture 2004. ∗ Tel.: +44 1620 515 458; fax: +44 1620 586 396. E-mail address: [email protected] (I.F.H. Purchase). 0300-483X/$ – see front matter © 2004 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.tox.2004.06.029 2 I.F.H. Purchase / Toxicology 202 (2004) 1–20 1. Introduction many cases of fraud and error in scientific activi- ties have been identified in other ways (e.g., whistle- It is a great honour to be asked to deliver the Paton blowing) suggests that the self-correcting mechanism Prize lecture. Sir William Paton, a former chairman is only partly successful. of the British Toxicology Society, endowed the Paton prize at the BTS as a means of encouraging the study of the history of science. His interests covered a wide 2. What is misconduct, fraud, error and area of science. He first came into prominence as a gamesmanship? consequence of his discovery of the methonium salts which caused neuromuscular and ganglion block. Hex- There have been many attempts at defining miscon- amethonium was used to reduce blood pressure during duct, both from a legalistic and practical point of view. surgical procedures. But he also became involved in Some argue that the final output of the scientific many other projects, such as hyperbaric physiology, process, the scientific paper, is itself fraudulent. This the mechanism of action of cannabis and the control is because ‘it represents a mythical reconstruction of of the doping of racehorses (Rang and Walton, 1996). what actually happened. All of what are in retrospect During his time as chairman of the BTS he was re- mistaken ideas, badly designed experiments and in- sponsible for encouraging the Society to look at the correct calculations are omitted. The paper represents use of the LD50 test and this resulted in the proposal to the research as if it had been carefully thought out, modify the methods used to study acute toxicity (the planned and executed according to a neat, rigorous BTS method). The BTS method provides information process, for example involving testing of a hypothe- on acute toxicity while reducing the adverse effects on sis. The misrepresentation of the scientific paper is the animals. formal aspect of the misrepresentation of science as Scientific investigation is widely believed to be the an orderly process based on a clearly defined method’ pursuit of objective truth with a view to providing ben- (Martin, 1992). It could also be argued that the publi- efits for humankind. The pursuit of truth is through the cation of scientific work overemphasizes the positive development and testing of hypotheses using reliable aspects of the work and exaggerates its quality and methods. In this respect, toxicology is no different, for could therefore, be called triumphalist. Part of the rea- while it’s principle aim is to uncover adverse effects, son for this is that scientific journals’ policy for the this is done with the purpose of discovering the ‘truth’ selection of manuscripts for publication favours ad- about the toxicity of a particular chemical. Such knowl- vances in science rather than statements of the status edge is essential in protecting human health and the quo. There are few journals with negative results in the environment. title. Misconduct in the form of fraud and carelessness The individual scientist is regularly faced with a seems out of place in this type of endeavour, because choice about what to include in a paper. There is cer- we expect that those involved in any enterprise should tainly no room for a description of the details of how be acting morally (Oderberg, 2000). That is, we expect individual experiments were conceived and conducted, that their essential objective is to carry out their task of where mistakes were made. The dividing line be- well. Thus, we expect that a toxicologist would aim to tween what is acceptable and what is unacceptable in carry out their toxicology work well and to act in the that choice is decided by unwritten rules of behaviour right way. determined largely by what authoritative scientists find It is argued that one defining characteristic of the acceptable and convey to scientists in training. scientific method is that it is self-correcting. Through Nevertheless, there are certain activities that all hold replication and verification of experimental work and to be unacceptable because they distort the search for by peer review of work proposals and reports of that ‘truth’. The literature on this topic identifies fabrica- work, the effects of error, bias and deception are elim- tion, falsification and plagiarism as the principle con- inated (Grayson, 1995). Many cases of fraud and er- cerns. The US Federal Policy on Research Misconduct ror have been identified through the operation of these provides the following definition (Rennie and Gunslas, ‘self-correcting’ mechanisms. However, the fact that 2001). I.F.H. Purchase / Toxicology 202 (2004) 1–20 3 2.1. Federal policy on research misconduct mean laboratory experimental work aimed at identify- ing the toxicity of chemicals and their mechanisms of 1. Research misconduct defined action. Research misconduct is defined as fabrication, falsi- Experimental toxicology, although practised for fication, or plagiarism in proposing, performing, or many centuries, came into its own as an experimen- reviewing research, or in reporting research results. tal subject early in the 20th Century. Chemicals be- • Fabrication is making up data or results and came important in commerce and affected lives in many recording and reporting on them. ways (through health care, agriculture, fabrics, house- • Falsification is manipulating research materials, hold products etc) leading to the interest in their safety. equipment, or processes, or changing or omitting Scientific methods of breeding and maintaining experi- data or results such that the research is not accu- mental animals were established, methods for growing rately represented in the research record. cells in culture and analytical methods for detecting • Plagiarism is the appropriation of other person’s small quantities of chemicals were also developing ideas, processes, results, or words without giving from the 1930s or before. Thus, both the incentive and appropriate credit. the methods for studying the toxicity of chemicals pro- Research misconduct does not include honest error vided an impetus to the subject. or differences of opinion. The practice of toxicology has developed rapidly in 2. Findings of research misconduct the intervening years. Much experimental work is de- A finding of research misconduct requires that: signed to describe the toxicity of new chemicals for • There be a significant departure from accepted regulatory purposes.
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