Criminalising research fraud

Editorial Editor: Ian Freckelton QC* CRIMINALISING RESEARCH FRAUD The incidence of research fraud has reached troubling levels. Too often peer review has failed to prevent it. The harm caused by such conduct extends to patients, co-authors, supervisors, employing institutions, funders, journals, publishers, and importantly, the area and direction of the research itself and its potential influence are tarnished. A number of commentators have raised the option of criminal charges being preferred against those responsible for such fraud. This has occurred in the United States, in particular, but also in the United Kingdom, Korea and Australia in high-profile cases. There is much to be said for this form of prosecutorial response to the phenomenon of research fraud given its multi-level ramifications, the considered nature of the conduct, and the fact that it is engaged in by persons well positioned to appreciate the harm that their deceit may cause. The involvement of the criminal law enhances the potential for deterrence from yielding to the temptation and opportunity to engage in research fraud. INTRODUCTION Concerns about the extent and ramifications of the commission of research fraud in the biomedical sciences have been building for some years. Multiple examples of grossly dishonest conduct of research have been exposed, including in oncology;1 AIDS research;2 anaesthesia;3 asthma treatment;4 cardiology;5 radiology;6 immunopharmacology;7 cardiovascular medicine;8 stem cell treatment;9 and * Barrister, Crockett Chambers, Melbourne, Australia; Professorial Fellow in Law and Psychiatry, University of Melbourne; Adjunct Professor of Law and Adjunct Professor of Forensic Medicine, Monash University, Australia. The author acknowledges with gratitude the assistance provided on an earlier draft from Dr Patricia Molloy. Correspondence to: Dr Ian Freckelton QC, c/o Barristers’ Clerk Howells, Owen Dixon Chambers West, 525 Lonsdale St, Melbourne, Vic, 3000, Australia, I.Freckelton@vicbar.com.au. 1 Dr Jon Sudbø, Dr Werner Bezwoda, Professor Roger Poisson; Associate Professor Anil Potti: see Letter from Norwegian Board of Health to Jon Sudbø, “Revocation of Authorization as Physician and Dentist” (21 November 2006), http:// www.helsetilsynet.no/no/Norwegian-Board-of-Health-Supervision/Decisions-in-individual-cases/Revocation-AuthorizationPhysician-Dentist viewed 30 November 2014; Sledge Jr GW, “Why Big Lies Matter: Lessons from the Bezwoda Affair” (2000) 5(1) Medscape Women’s Health 4; Fisher B and Redmond CK, “Fraud in Breast Cancer Trials” (1994) 330 N Engl J Med 1458; Keranen L, Scientific Characters: Rhetoric, Politics and Trust in Breast Cancer Research (University of Alabama Press, Alabama, 2010). 2 Dr Dong Pyou-Han: see Health and Human Services Department, “Finding of Research Misconduct in relation to Dong-Pyou Han” (23 December 2013), https://www.federalregister.gov/articles/2013/12/23/2013-30424/findings-of-research-misconduct viewed 17 August 2014; Office of Research Integrity, “Case Summary: Han, Dong-Pyou” (23 December 2013), http://ori.hhs.gov/content/case-summary-han-dong-pyou viewed 17 August 2014. 3 Professor Joachim Boldt and Professor Yoshitaka Fujii: see Wise L, “Boldt: The Great Pretender” (2013) 346 BMJ 1738. 4 Dr Edward Erin: see Lawless J, “Exposed: The Asthma Drug Trials that Led to Cancer and Death”, The Independent (18 June 2013); McNeill D, “Japanese Fraud Case Highlights Weaknesses in Scientific Publishing”, Chronicle of Higher Education (8 October 2012). 5 Dr John Darsee: see Kochan A and Budd JM, “The Persistence of Fraud in the Literature: The Darsee Case” (1992) 43(7) J Am Soc Inf Sci 488. 6 Dr Robert Slutsky: see Engler RL, Covell JW, Friedman PJ, Kitcher PS, Peters RM, “Misrepresentation and Responsibility in Medical Research” (1987) 317 N Engl J Med 1383. 7 Professor Alirio Melendez, Professor Dipak Das and Dr Judy Mikovits: see Yung A and Sharma Y, “Academic Found Guilty of Fraud on ‘Unprecedented’ Scale”, University World News (11 January 2013); Wade N, “University Suspects Fraud by a Researcher Who Studied Red Wine”, The New York Times (11 January 2012); Tuller D, “Fallout from Fatigue Syndrome Retraction is Wide”, The New York Times (6 February 2012). (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton nanotechnology.10 The frauds have necessitated retractions in scholarly journals at an unparalleled level. They have prompted anxious debate about research integrity and mechanisms for investigation of allegations of misconduct. They have also precipitated removal of perpetrators from the lists of those who are eligible for government (and other) sources of funding and resulted in many researchers who until then had been well regarded losing their academic positions. However, the question arises as to whether the sanctions that have been taken are sufficient when the seriousness of the consequences of the conduct is factored into consideration. In a series of high-profile cases, in the United States, the United Kingdom and Korea, and now also in Australia, research scholars who have been alleged to have engaged in brazen forms of fraud have been criminally prosecuted in recent years. This editorial reviews examples of such prosecutions, analyses the results in those cases that have been completed, and argues in favour of viewing research fraud as a form of white collar crime at risk of being engaged in opportunistically by persons of high standing within the scholarly community. It contends that the repercussions of such fraud can be highly damaging for patients, co-authors, supervisors and the discipline concerned and that the risk of harm, as well as the substantial sums of money involved, justify the intrusion of the criminal law. THE CONTROVERSIES OVER CRIMINALISATION OF RESEARCH FRAUD It is often observed that the criminal law is a blunt instrument for improving behaviour.11 For instance, this dilemma has often been identified in relation to public health law.12 However, there has been a growing view that the commission of deliberate research fraud (such as by fabrication of data) justifies the involvement of the criminal law in order to impose condign punishment and meaningful deterrence. In 1991, Susan Kuzma of the United States Department of Justice argued that: [u]npleasant and unsettling as it is to contemplate, criminal prosecution can serve a valuable role in deterring and condemning some forms of scientific misconduct and therefore should not be rejected in favour of internal controls.13 In 2000, Professor Alexander McCall Smith, then a Professor of Law and Medical Ethics at the University of Edinburgh, addressed a summit on research misconduct and argued that wilful fraud should be criminalised. By 2013, an editorial in Nature argued in favour of the application of criminal penalties for research fraud: Science likes to shelter its crooks with euphemisms. The prefix “research” softens fraud, and to deliberately obtain public money through deception gets labelled misconduct, among other things. This reflects the fact that the crime is viewed as being against professional standards rather than against the laws of wider society. At the very least, academic investigators could learn from police methods for dealing with allegations of serious misconduct … And researchers might be less tempted to be cavalier with the truth – and with our money – if they knew who else could knock on their door.14 Richard Smith, a former editor of the British Medical Journal, also argued in 2013 that the incidence of scientific fraud has reached a point where it is failing the public and it is time to 8 Dr Don Poldermans: see Erasmus MC Follow-Up Investigation Committee, Report on the 2012 Follow-Up Investigation of Possible Breaches of Academic Integrity (30 September 2012), http://cardiobrief.files.wordpress.com/2012/10/integrity-report2012-10-english-translation.pdf viewed 25 April 2014. 9 Professor Woo-Suk Hwang and Dr Haruko Obokata: see Editorial, “STAP Retracted” (2014) 511 Nature 5; Saunders R and Savulescu J, “Research Ethics and Lessons from Hwanggate: What Can We Learn from the Korean Cloning Fraud?” (2008) 34 J Med Ethics 214. 10 Dr Jan Hendrik Schön: see Reich ES, Plastic Fantastic: How the Biggest Fraud in Physics Shook the Scientific World (Palgrave Macmillan, New York, 2009). 11 See, for example, Duffee D and Allan E, “Criminal Justice, Criminology and Criminal Justice Theory” in Duffee D and Maguire ER (eds), Criminal Justice Theory: Explaining the Nature and Behavior of Criminal Justice (Routledge, New York, 2007). 12 See, for example, Viens AM, Coggon J and Kessel AS (eds), Criminal Law, Philosophy and Public Health Practice (Cambridge University Press, Cambridge, 2013) pp 189-190. 13 Kuzma SM, “Criminal Liability for Misconduct in Scientific Research” (1992) 25 Univ Mich J Reform 357 at 357. 14 “Call the Cops” (2013) 504 Nature 7, http://www.nature.com/news/call-the-cops-1.14288 viewed 1 March 2014. 242 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial criminalise research fraud.15 There are many reasons to conclude that peer review is ineffectual in the face of cynically orchestrated fabrication of data. In 2014, the Medical Journal of Australia16 polled its readers, asking: “Should medical research fraud be treated as a criminal offence?” Seventy-three per cent of respondents replied in the affirmative, with 23% saying “Maybe” and just 4% asserting that it should not be treated as criminal conduct. In Canada, Professor Zulfiqar Bhutta, co-Director of the Centre for Global Child Health at Toronto’s Hospital for Sick Children, maintained in 2014 that: When somebody is determined to commit something like this and does, and if it is brought to light, then I think the full weight of law needs to come on that person … Individuals generally get off with just a slap on the wrist at the time and at the most a dismissal from service.17 However, not all agree. Research Professor Julian Crane, Director of the Wellington Asthma Research Group at the Wellington School of Medicine at the University of Otago in New Zealand has contended that the research system should work collaboratively: Criminalizing research fraud is a sad, bad, even mad idea that will only undermine the trust that is an essential component of research and requires good governance, not criminal investigators.18 A review of prominent examples of research fraud which have been so egregious as to prompt the preferring of criminal charges brings the issue into sharp focus. Stephen Breuning During the 1980s, the psychologist, Dr Stephen Breuning, was one of the United States’ most prominent researchers in the field of treatment of mental retardation.19 He was employed by the University of Pittsburgh. He was particularly known for his work in relation to the use of Ritalin and Dexadrine for treating Attention Deficit Hyperactivity Disorder (ADHD).20 In 1983, Robert Sprague, a Professor of Psychology at the University of Illinois, was informed by a young colleague that Breuning was obtaining perfect agreement between nurses in their independent ratings of tardive dyskinesia movements of patients being prescribed medication in circumstances where this was highly unlikely.21 Sprague undertook his own investigations and found that an abstract that Breuning had submitted for a symposium on tardive dyskinesia, claiming to have examined 45 patients, was almost certainly faked. He identified that a number of aspects of Breuning’s research in relation to tranquilliser medication for intellectually disabled children were falsified. This led him to report his concerns to the National Institute of Mental Health (NIMH), which referred the issues to the University of Pittsburgh. When confronted with the concerns of Sprague, Breuning made some admissions to falsification of a report, and resigned from the faculty. As the conduct in respect of the study related to work done 15 Smith R, “Should Scientific Fraud Be a Criminal Offence?”, BMJ Group Blogs (9 December 2013). See also Adams M and Oransky I, “Commit Fraud, Go to Jail”, Labtimes (2014), http://labtimes.org/labtimes/ranking/dont/2014_01.lasso viewed 24 March 2014; Noble Jr JH, “Is Fraudulent Science Criminal?”, CardioExchange (10 February 2014), http:// www.cardioexchange.org/voices/is-fraudulent-science-criminal/comment-page-1/#comment-4222 viewed 29 November 2014; Richardson S, “When Human Experimentation is Criminal” (2009) 99(1) J Crim L & Criminology 89. 16 “MJA Insight Poll” (2014) 201(7) MJA 373. 17 See Branswell H, “Should Research Fraud be Treated as a Crime? Toronto Expert Says Yes”, The Prince George Citizen (15 July 2014), http://www.princegeorgecitizen.com/life/health/should-research-fraud-be-treated-as-a-crime-toronto-expert-saysyes-1.120 viewed 29 November 2014. 18 Branswell, n 17. 19 See Boffey PM, “US Study Finds Fraud in Top Researcher’s Work on Mentally Retarded”, The New York Times (24 May 1987), http://www.nytimes.com/1987/05/24/us/us-study-finds-fraud-in-top-researcher-s-work-onmentally-retarded.html viewed 30 November 2014. 20 See Scott J, “Researcher Admits Faking Data to Get $160,000 in Funds”, Los Angeles Times (20 September 1988), http://articles.latimes.com/1988-09-20/news/mn-2318_1_research-fraud viewed 30 November 2014. 21 See Kimmel AJ, Ethical Issues in Behavioral Research: Basic and Applied Perspectives (Wiley & Sons, New York, 2009) p 303. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 243 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton before Breuning had joined the university, the university investigative committee that had been convened concluded that it did not have jurisdiction over the issues raised.22 However, Sprague declined to let the matter rest and agitated with the NIMH itself to investigate the conduct of Breuning on the basis that it was the body that had funded much of Breuning’s research. In February 1985, the NIMH agreed and appointed an expert review panel. In 1986, the panel concluded that Breuning engaged in “serious scientific misconduct” in that he “knowingly, wilfully, and repeatedly engaged in misleading and deceptive practices in reporting results of research”. Although his studies were supposedly based on research involving thousands of subjects, it concluded that “only a few of the experimental subjects described in publications and progress reports were ever studied”.23 The panel commented that its work was “complicated by Breuning’s shifting and often contradictory explanations” of where various studies were said to have been carried out. As a result of the panel report, the Federal Alcohol, Drug Abuse and Mental Health Administration recommended that Breuning be banned from receiving grants or contracts from funders for 10 years. It also recommended that the Justice Department prosecute Breuning. Breuning’s response was to denounce the panel review as no more than a “shoddy investigation” and to maintain that the findings on which he had reported had not been disproved and that other scientists had reproduced some of them.24 However, matters went further and Breuning was charged with two counts of filing false information on a research grant application. He pleaded guilty before the District Court of Maryland and was sentenced to 60 days in a halfway house, five years of probation, 250 hours of community service, repayment of $11,352, and to abstain from psychological research for the period of his probation.25 He agreed not to undertake any work as a psychologist for at least 10 years. However, for a concerning period of time, fear of legal action inhibited efforts to record retractions of Breuning’s fraudulent research in prominent journals and thereby to curtail the influence of his spurious research.26 A co-author of Breuning, Dr Alan Poling, reflected later on the ramifications of the Breuning frauds (of which he had been unaware at the time of their commission).27 He started from the proposition that “[f]raud compromises science in every respect”28 and mused: “I wonder what the outcome would have been in the absence of a Robert Sprague.”29 He expressed concern that clinical decisions about the pharmacological treatment of retarded children may have been based on Breuning’s fraudulent data30 and declaimed: A scientist who engages in fraudulent practices is not guilty of petty mischief that results in personal gain but harms no one. Fraud destroys the very fabric of science, and its consequences are as egregious 22 See Lewis M, Poisoning the Ivy: The Seven Deadly Sins and Other Voices of Higher Education (ME Sharpe, New York, 1997) p 132 23 Boffey, n 19. 24 Boffey, n 19. 25 See Byrne G, “Breuning Sentenced” (1988) 242 Science 1004; Salhab M, “A History of Fraud and Deceit in Medical Research” (2010) 5(1) Surgery Journal 1; Greenberg DS, “Issue of Scientific Fraud Not Easily Faced”, Chicago Tribune News (16 August 1989), http://articles.chicagotribune.com/1989-08-16/news/8901050101_1_stephen-e-breuning-federal-charges-nimh viewed 20 April 2014 26 See Hostetler AJ, “Fear of Suits Blocks Retractions”, The Scientist (19 October 1987), http://www.the-scientist.com/? articles.view/articleNo/9012/title/Fear-of-Suits-Blocks-Retractions viewed 30 November 2014. 27 Poling A, “The Consequences of Fraud” in DJ Miller and M Hersen (eds), Research Fraud in the Behavioral and Biomedical Sciences (John Wiley & Sons, New York, 2002) p 140. 28 Poling, n 27, p 141. 29 Poling, n 27, p 142. 30 See also Garfield E and Welljams-Dorof A, “The Impact of Fraudulent Research on the Scientific Literature: The Stephen E Breuning Case” (1990) 263(10) JAMA 1424; Salhab M, “A History of Fraud and Deceit in Medical Research” (2010) 5(1) Surgery Journal 1. 244 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial as enduring. For these reasons, legitimate scientists must recognise fraud for the serious problem that it is. They must be willing to confront it at the level of specific cases and general issues.31 Luk Van Parijs In 2004, Luk Van Parijs was an Associate Professor of Biology at the Massachusetts Institute of Technology (MIT). He was confronted by members of his laboratory with allegations that he had engaged in data falsification. He made immediate admissions and was sacked from MIT after a year-long investigation. He was also subject to investigations by Harvard Medical School where he had been a graduate student and by the California Institute of Technology at Pasadena where he had been a postdoctoral student, as well as by the Office of Research Integrity (ORI) of the United States Department of Health and Human Services (HHS). It became apparent that Van Parijs had engaged in a pattern of research fraud between 1997 and 2004 in research funding applications into the shutting down of genes via virus-based techniques, including via the mechanism of ribonucleic acid (RNA) interference.32 In 1997, a neuroimmunologist at the University of London expressed concerns about a paper co-authored by Van Parijs published in the same year by the Journal of Experimental Medicine. Van Parijs was then a graduate student. It was not until 2009 that the neuroimmunologist received a letter of apology from the journal, apologising for its lack of response to the 1997 communication. She declined to comment on the suggestion that action by the journal in a timely way might have averted the later scandal which enveloped years of Van Parijs’ research.33 In February 2011, Van Parijs was charged in the District Court of Boston on the basis of a 2003 grant application to the National Institutes of Health (NIH) for which he was responsible. He entered a plea of guilty. The government sought a six-month jail term to deter others minded to behave similarly, according to Assistant Prosecutor Noonan, but Judge Denise Casper opted instead to impose a sentence of six months of home detention with electronic monitoring, 400 hours of community service and a payment of US$61,117 to MIT for money that had to be returned to the NIH. She accepted that Van Parijs was genuinely remorseful. A whistleblower in his case who spoke to Nature had a different perspective: Luk’s actions resulted in many wasted years as people struggled to regain their career paths. How do you measure the cost to the trainees when their careers have been derailed and their reputations brought into question?34 Eric Poehlman A United States researcher to be sentenced to actual jail time for research fraud was Eric Poehlman, a physiologist from the University of Vermont, who published prolifically for two decades in the fields of human obesity and ageing. His sentencing by Judge William Sessions III in 200635 constituted a landmark in the regulation by the criminal law of research fraud. Poehlman’s exposure began in the autumn of 2000 when a 24-year-old research technician, Walter DeNino, who had graduated with a double major in nutritional sciences and dietetics, was comparing measurements in patient data taken several years apart and provided to him by Poehlman in relation to how fat lipids in the blood change with age. Poehlman anticipated that the data would show an increase in low-density lipoprotein which deposits cholesterol in arteries, and show a decrease in 31 Poling, n 27, p 154. 32 See Reich ES, “Fraud Case We Might Have Seen Coming”, Nature (online) (28 July 2011), http://www.nature.com/news/ 2011/110728/full/news.2011.437.html viewed 8 December 2014. 33 Reich, n 32. 34 Reich ES, “Biologist Spared Jail for Grant Fraud” (2011) 474 Nature 552, http://www.nature.com/news/2011/110628/full/ 474552a.html viewed 30 November 2014. 35 See Dalton R, “Obesity Expert Owns Up to Million-Dollar Crime” (2005) 434 Nature 424. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 245 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton high-density lipoprotein which carries it to the liver for break down. However, a first run through of the data by Poehlman did not support the research hypothesis.36 Poehlman took the electronic data home and returned them to DeNino the next week explaining that he had corrected some mistaken entries and asked DeNino to run another statistical analysis. The trend reversed but when DeNino compared the two sets of data the changes in patient data all supported Poehlman’s hypothesis for no apparent reason. When DeNino confronted Poehlman about the discrepancies and asked to see the patient files to check the integrity of the results, Poehlman declined and dismissed his concerns. DeNino contacted a postdoctoral fellow who had also worked for Poehlman and had had similar experiences and been implicitly threatened with the loss of his job if he continued to raise his concerns. After further investigations confirmed his concerns, DeNino approached the University of Vermont’s general counsel and lodged a formal allegation of scientific misconduct. It took six years to resolve, with Poehlman in his first written response suggesting that there were difficulties with his data but that these were attributable to errors brought about due to the handling of the data by multiple technicians and postdoctoral students over the years. When he appeared before an investigative panel, he claimed to be inept with Excel files, accused persons such as DeNino of plotting against him, and maintained that DeNino had examined data that were merely imputed and not the actual data. When the university proceeded from an investigative panel to a formal investigation, Poehlman sought an injunction from the courts to stop it, attempting to impugn the credibility of DeNino by suggesting that DeNino was homophobic and anti-gay.37 The formal investigation by the University of Vermont in 2001,38 oversighted by the ORI,39 established that the concerns raised by DeNino were justified. It found that Poehlman fabricated data as part of a longitudinal study of ageing and projects in respect of transitions to menopause, hormone replacement therapy and weight loss. In concluded that, in each instance: Poehlman has committed scientific misconduct for the purpose of placing into the scientific literature results that, although unsupported by research, would be consistent with his theories of age-related deterioration, likely to enhance his reputation, and likely to yield him further opportunities for publication and grant funding.40 Ultimately, Poehlman acknowledged falsifying 17 grant applications to the NIH for nearly US$3 million, and fabricating data in 10 published articles between 1992 and 2001 to whose retraction he agreed.41 He also entered into a voluntary exclusion agreement in which he agreed: (1) to exclude himself permanently from serving in any advisory capacity to PHS [Public Health Service] including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant; (2) to exclude himself permanently from any contracting or subcontracting with any agency of the United States government and from eligibility or involvement in non-procurement programs of the United States government referred to as “covered transactions” … the respondent agrees that he will not petition HHS to reverse or reduce the scope of the permanent voluntary exclusion or administrative actions that are the subject of this Agreement; and 36 Interlandi J, “An Unwelcome Discovery”, The New York Times (22 October 2006), http://www.nytimes.com/2006/10/22/ magazine/22sciencefraud.html?pagewanted=all viewed 30 November 2014. 37 Interlandi, n 36. 38 University of Vermont College of Medicine, Office of the Dean, Investigation Report into the Matter of Eric T Poehlman (2002), http://www.ori.dhhs.gov/sites/default/files/uvm_report.pdf. 39 Dahlberg JE and Mahler CC, “The Poehlman Case: Running Away from the Truth” (2006) 12(1) Sci Eng Ethics 157. 40 University of Vermont College of Medicine, n 38, p 39. 41 Office of Research Integrity, “Case Summary: Poehlman Eric T” (15 January 2013), http://www.ori.dhhs.gov/content/casesummary-poehlman-eric-t viewed 1 February 2014. 246 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial (3) to execute and deliver letters requesting retraction or correction to the editors of the journals that published the 10 papers named in the Agreement and cited above, and to sign the letters requesting the retraction or correction prepared for his signature by ORI without alteration or modification in any way.42 At his sentencing hearing, Poehlman acknowledged that he needed to start by apologising: Speaking quickly and stammering occasionally, he apologized to friends and former colleagues, some of whom were listening in the back of the courtroom. He apologized to his mother, who sat in the front row, crying. And he apologized to Walter DeNino, the former protégé who turned him in, who was also sitting in the courtroom, several rows back on the prosecution’s side. “I have wanted to say I’m sorry for five years,” Poehlman said, without turning around to face DeNino. “I want to make it very clear I am remorseful. I accept the responsibility. There’s no way that I can turn back the clock. And I’m not that individual that I was years ago.”43 In a letter to the judge he explained that he was “motivated by my own desire to advance as a respected scientist” and added that he was: ashamed of myself for falsifying and fabricating data … I believed that because the research questions I had framed were legitimate and worthy of study, it was okay to misrepresent “minor” pieces of data to increase the odds that the grant would be awarded.44 Poehlman was sentenced to one year and a day in federal prison, followed by two years of probation. Judge Session said in sentencing him: When scientists use their skill and their intelligence and their sophistication and their position of trust to do something which puts people at risk, that is extraordinarily serious. In one way, this is a final lesson that you are offering.45 An action was also brought against Poehlman, among other things, under the False Claims Act (also known as “the Lincoln Law”).46 It was settled in 2005 with Poehlman agreeing to pay US$180,000 to the United States government over a three-year period, with De Nino (the relator) receiving a 12% share of that sum and Poehlman paying De Nino’s legal costs.47 The Poehlman case generated considerable reflection within the United States medical community. Poehlman succeeded by producing results that confirmed pre-existing research hypotheses. This conduced against critical evaluation. He was popular and charismatic. He was also very successful, which meant that many researchers were financially dependent on him and his continuing grant successes. Poehlman, perhaps in later self-justification, maintained that he felt highly responsible for other researchers who were financially reliant on him. He said that he became “grant-dependent. But it created a maladaptive behavior pattern. I was on a treadmill, and I couldn’t get off”.48 A more critical perspective has been provided by Sox and Rennie who have argued that five lessons need to be learned from the Poehlman frauds: First, the scientific community must assume that every article written by an author who has committed scientific fraud is unreliable until someone close to the work has explained the specific reasons why he or she can vouch for its integrity. Second, the guilty scientist’s coauthors bear primary responsibility for publicly validating or retracting their joint publications. Third, journal readers cannot necessarily count 42 Office of Research Integrity, “Case Summary: Eric T Poehlman” (24 March 2005), http://ori.hhs.gov/poehlman_notice viewed 30 November 2014. 43 Interlandi, n 36. 44 Kintisch E, “Poehlman Sentenced to 1 year of Prison”, Science (online) (28 June 2006), http://news.sciencemag.org/2006/06/ poehlman-sentenced-1-year-prison viewed 30 November 2014. 45 Interlandi, n 36. 46 31 USC § 3729(a), as well as under the provisions of permissive exclusion under the Medicare, Medicaid and other federal health care programs. 47 United States of America v Poehlman, “Settlement Agreement and Stipulation for Entry of Judgment” (D Vt, 11 March 2005), http://www.ori.dhhs.gov/sites/default/files/poehlman_settlement_agreement_final.pdf viewed 30 November 2014. See also Tereskerz PM, Clinical Research and the Law (John Wiley & Sons, New York, 2012) p 131ff. 48 Interlandi, n 36. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 247 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton on journal editors to retract tainted articles. Fourth, in the interests of transparency, editors should use the word “retraction” only in cases of fraud. Finally, even when a journal has published a retraction, authors continue to cite a fraudulent article, often for years.49 Woo-Suk Hwang One of the most notorious scientific frauds of recent years was that generated by Professor Woo-Suk Hwang,50 a high-profile South Korean veterinarian and an academic at Seoul National University, who claimed in 200451 to have been the first person to have created human stem cell lines using cloned embryos derived from patients suffering from spinal cord injury and other disorders. In an article announcing the breakthrough, Hwang and colleagues maintained that they had used 242 eggs derived from 16 volunteers. However, question marks emerged at an early juncture about the team’s adherence to ethical proprieties with claims that junior members of the research team had donated their eggs.52 Hwang and colleagues played a key role in creating an Afghan hound, Snuppy, the world’s first cloned dog.53 In January 2006, Hwang admitted to falsifying data, although he persisted in the assertion that he had the ability to do what he had claimed. Hwang had been the only scientist in South Korea licensed to undertake human stem cell research but in 2006 the government revoked his licence. In South Korea, scientific fraud was illegal only if a person used fraudulent data to gain grants.54 Prosecutors argued that he duped two companies, SK Group and NongHyup, into supplying research funds but the court in which he faced the charges rejected the allegations on the ground that the firms provided money without expecting to benefit.55 However, Hwang was found guilty of buying human eggs in violation of Korea’s bioethics law and of embezzling 830 million won (A$700,000) of government money. The scientific community was divided about how the court should deal with Hwang. Alan Colman, a stem cell scientist at the Institute of Medical Biology in Singapore, expressed the view that Hwang was a talented experimentalist and that he should be excluded from eligibility from research funding for a stipulated period of time.56 In June 2009, Hwang received an award from the Jang Yeong-sil Memorial Foundation for scientific excellence. Two months later, the South Korean province of Gyeonggi announced that it planned a collaboration with Hwang to develop transgenic animals able to grow organs for transplantation to humans. In October 2009, 33 parliamentarians submitted a petition to the Seoul Central District Court Criminal Division pleading for leniency in sentencing Hwang so that he could continue his research without impediment.57 Seoul District Court Judge Bae Ki-ryul imposed a two-year jail sentence, suspended for three years, although the prosecution had sought a four-year jail term to be actually served. The lesser sentence was imposed on the basis of what the sentencing judge classified as Hwang’s dedication to the development of Korea’s biotechnology, his lack of a criminal record and his deep remorse. Both the prosecution and Hwang appealed to the Seoul High Court against the convictions but the 49 Sox HC and Rennie D, “Research Misconduct, Retraction, and Cleansing the Medical Literature: Lessons from the Poehlman Case” (2006) Annals of Internal Medicine 609 at 612-613. 50 See Mandevilli A, “Profile: Woo-Suk Hwang” (2005) 11 Nature Medicine 464; Cyranoski D, “Verdict: Hwang’s Human Stem Cells Were All Fakes” (2006) 439 Nature 122; Saunders and Savulescu, n 9. 51 See Hwang HS et al, “Evidence of a Pluripotent Human Stem Cell Line Derived from a Cloned Human Blastocyst” (2004) 303 Science 1669, since retracted, http://www.sciencemag.org/content/303/5664/1669.full viewed 30 November 2014; Hwang HS et al, “Patient-Specific Embryonic Stem Cells Derived from Human SCNT Blastocysts” (2005) 308 Science 1777. 52 See Cyranoski D, “Korea’s Stem Cell Stars Dogged by Suspicion of Ethical Breach” (2004) 429 Nature 3. 53 See Lee B at el, “Dogs Cloned from Adult Somatic Cells” (2005) 436 Nature 641. 54 Cyranoski D, “Woo-Suk Hwang Convicted, But Not of Fraud” (2009) 461 Nature 1181. 55 Si-soo P, “Hwang Convicted of Embezzlement, Cleared of Fraud”, The Korea Times (26 October 2009), http:// www.koreatimes.co.kr/www/news/nation/2009/10/117_54275.html viewed 24 January 2014 56 Cyranoski, n 54. 57 Cyranoski D, “Hwang Sentence Imminent” (2009) 461 Nature 1035. 248 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial convictions were upheld, save one as to an embezzlement. On 16 December 2010, the High Court reduced Hwang’s sentence to an 18-month jail term wholly suspended for two years. Hwang then appealed to the Supreme Court but was unsuccessful in early 2014.58 The court also sent Hwang’s plea to overturn his dismissal from Seoul National University back to a lower court for review and upheld previous rulings acquitting him of fraud charges. The ruling came two weeks after Hwang obtained a United States patent for a purportedly cloned human embryonic stem cell line. Scott Reuben Scott Reuben was the Professor of Anesthesiology and Pain Management at Baystate Medical Center in Springfield, Massachusetts. He was educated at Columbia University and graduated from medical school at the State University of New York at Buffalo in 1985. He undertook his anaesthesiology residency at the Mount Sinai Medical Center in New York. In 1991, he joined Bayside which serves as the western campus for Tufts University School of Medicine. Over a period of some 12 years, Reuben worked and published on the way in which pain relief is provided to patients undergoing orthopaedic surgery. His work sought to encourage surgeons to move away from the first generation of nonsteroidal anti-inflammatories (NSAIDs) to multimodal analgesia therapy utilising the newer COX-2 inhibitors,59 such as Merck’s Vioxx and Pfizer’s Celebrex and Bextra. He claimed that using such drugs in combination with Pfizer’s anticonvulsant Neurontin and later Lyrica before and during surgery decreased post-operative pain and the use of addictive opiate painkillers such as morphine. A 2007 editorial in Anesthesia and Analgesia stated that Reuben had been at the “forefront of redesigning pain management protocols” through his “carefully planned” and “meticulously documented” studies. The drugs the subject of Reuben’s published research were highly controversial, Vioxx and Bextra being withdrawn from sale in 2004 because of what by then had emerged as an elevated risk of heart attacks, thrombosis and strokes for their users. This left Celebrex as the only available COX-2 inhibitor available but with a major cloud over its safety. Reuben was a member of Pfizer’s speaker’s bureau and received five independent research grants from Pfizer. His studies consistently were supportive of Pfizer’s claims as to the efficacy and safety of Celebrex. Starting in 2000, Reuben entered into contracts with Pfizer, Merck and Wyeth to perform research funded by the companies and to publish the results of his research: In his 2002 article for the Journal of Arthroplasty, Reuben claimed to have enrolled 100 patients. However, he later admitted to having only collected data on 26 patients. For a 2008 article in Anesthesia and Analgesia, he claimed to have collected data on 200 patients; in fact, he had no data at all.60 In at least one instance, Reuben forged the name of a co-author on a manuscript – an incident of fraud that came to light as a result of inquiries by Anesthesiology News.61 In submissions to the United States District Court (District of Massachusetts), Reuben contended that he had not been motivated by greed and that the funds which he received from pharmaceutical companies went to his employer. It was urged on his behalf that Reuben did not need the publications to further his career. It was argued for him that what fueled Dr Reuben’s wrongful acts between 2000 and 2008 was his undiagnosed bipolar disorder. It was contended on his behalf that he had not engaged in any form of inadequate patient care, his wife had left him, he had attempted suicide, he had liquidated almost all his savings to repay the pharmaceutical companies and his professional reputation had been devastated. The court received submissions from the prosecution urging 58 See Sang-Hun C, “Korean Scientist’s New Project: Rebuild After Cloning Disgrace”, The New York Times (28 February 2014), http://www.nytimes.com/2014/03/01/world/asia/scientists-new-project-rebuild-after-cloning-disgrace.html viewed 30 November 2014. 59 COX-2 inhibitors are a form of NSAID which directly targets COX-2, an enzyme responsible for inflammation and pain. Selectivity for COX-2 has the potential to reduce adverse effects of other NSAIDs, including renal failure. 60 Marcus A, “Reuben Sentenced in Fraud Case”, Anesthesiology News (25 June 2010). 61 Marcus, n 60. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 249 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton imposition of a jail sentence of 14 months and from the defence urging the imposition of home detention. It determined to impose a six-month sentence of imprisonment. The 2010 prosecution of Reuben sent tidal waves of warning throughout the international research community. Reuben was described in 2010 by Brendan Borrell in Scientific American as “A medical Madoff”.62 However, what is most significant about the Reuben saga was the involvement of the criminal law. The government prosecution signalled preparedness by regulatory authorities (at least in the United States) to initiate not just disciplinary proceedings, but also criminal proceedings, against those suspected of having misused research funding for career or pecuniary advantage. The essence of the prosecution consisted in Reuben being charged with, and pleading guilty to, having obtained financial advantage by research deception.63 The criminal conduct involved defrauding pharmaceutical companies, falsifying clinical research results, sending false articles based on false research results to a number of scholarly journals which then published these false articles, which in turn led members of the pain management medical community to read these false articles and in some instances base their treatment protocols for their patients on the false article they read. The prosecution tendered a victim impact letter by the editor of the Journal of Bone and Joint Surgery which attested to having published an article by Reuben that “purported to define a new method of pain management following spinal fusion, a procedure which is performed more than 250,000 times a year in the United States alone” and explained the measures taken by the journal after the fraudulent nature of Reuben’s publication was identified. The letter concluded that the: reputation of the Journal of Bone and Joint Surgery as an absolutely reliable source of quality patient care information has been permanently damaged, and we will never fully recover. Most importantly, while it is impossible to measure, many patients have been adversely affected by his [Reuben’s] actions. Similarly, in a further exhibit tendered by the prosecution, Dr Jacques Chelly, Director of the Division of Regional Anesthesia and Acute Interventional Pain at the University of Pittsburgh Medical Center, said that a consequence of Reuben’s fraud was that multimodal analgesia had been left “in shambles concerning many of the drugs we use. The big chunk of what people had based their protocol on is gone”. The wisdom of hindsight suggests that conduct by persons such as Reuben is very difficult for journal editors and reviewers to detect.64 However, the case instances the harm that can be done by research fraud that fabricates results to achieve predetermined objectives, whether those are of direct pecuniary advantage to the perpetrator or generated by other motivations. Victims include journal reputations and, in the medical arena, patients whose treaters are persuaded on the basis of unmeritorious research to use treatment modalities they would not otherwise have adopted. Craig Grimes In 2012, a Pennsylvania State Professor of Material Sciences and Engineering, Craig Grimes, was charged with US$3 million of research frauds between 2005 and 2011 arising from research into the potential to convert carbon dioxide into energy.65 His victims included Pennsylvania State University, the NIH and the National Science Foundation (NSF). Grimes sought a US$1,196,000 grant from the NIH to perform research related to the measurement of gases in a patient’s blood. The trial was funded on the basis of the importance of the measurement of such gases in detecting the presence of a disease in newborn babies in necrotising 62 Borrell B, “A Medical Madoff: Anesthesiologist Faked Date in 21 Studies”, Scientific American (10 March 2010), http://www.scientificamerican.com/article/a-medical-madoff-anesthestesiologist-faked-data viewed 30 November 2014. 63 The charge was health care fraud in violation of 18 USC § 1347. 64 See Rittner HL, Kranke P, Schafer M, Roewer N and Brack A, “What Can We Learn from the Scott Reuben Case: Scientific Misconduct in Anaesthesiology” (2009) 58(12) Anaesthetist 1199. 65 Miller D, “Former Penn State Professor Pleads Guilty to Defrauding Government of $3 Million in Grants”, Penn Live (21 February 2012), http://www.pennlive.com/midstate/index.ssf/2012/02/former_penn_state_professor_cr.html viewed 30 November 2014 250 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial enterocolitis.66 He represented in the application that he would direct US$509,274 to the Hershey Medical Center to conduct clinical research on adult and infant subjects. However, the money was never paid, instead being misappropriated in part for his own use. The clinical studies were never performed.67 Part of his misrepresentations included a US$1.9 million grant application to the Department of Energy in 2009. As part of the application, Grimes represented he had not received other funding for the project when in fact he had received a grant of funding for the same research from the NSF. University administrators queried him about having two grants that sounded very similar but he assured them there was no overlap, although he openly acknowledged both sources of funding in a 2010 publication. The Department of Energy Inspector-General identified the similarity in the two grants and the NSF began its investigation into whether there had been precluded duplication.68 Grimes resigned his position at Pennsylvania State University. After leaving Pennsylvania State University, Grimes was employed as a full-time Professor of Material Science and Engineering at Nanjing Industry University, but suspended in 2012 as the criminal proceedings became imminent.69 On 30 November 2012, United States Middle District Chief Judge Kane sentenced Grimes to 41 months’ imprisonment and ordered him to repay more than US$640,000 in restitution to his university and the NIH and NSF. Grimes maintained that he had been overtaken with research zeal and ignored grant rules and regulations, while the prosecutor, Assistant Attorney Joseph Terx, summarised his position, contending that Grimes “is not a mad scientist. He’s a dishonest scientist”.70 Steven Eaton In 2013, Steven Eaton became the first person in the United Kingdom to receive a jail sentence for falsifying clinical test results. Eaton had been employed by the Edinburgh branch of the United States pharmaceutical firm, Aptuit, to conduct preclinical trials on animals to assess the efficacy of new treatments on behalf of several drug companies. The Edinburgh Sheriff Court was informed that between 2003 and 2009 Eaton manipulated results of experiments to make it appear that they had been successful when in fact they had failed.71 He selectively reported analytical data used to assess whether analytical methods were working effectively to assess the concentration of a drug in the blood.72 When his superiors identified Eaton’s fraud, they reported him to the Medicines and Healthcare Products Regulatory Agency which prosecuted him under the Good Laboratory Practice Regulations 1999 (UK). 66 See generally Thompson AM and Bizzarro MJ, “Necrotizing Enterocolitis in Newborns: Pathogenesis, Prevention and Management” (2008) 68(9) Drugs 1227. 67 United States Attorney’s Office, Middle District of Pennsylvania, “Former Penn State Professor Who Plead Guilty in $3 Million Federal Research Grant Fraud Sentenced in Federal Court” (Press Release, 30 November 2012), http:// www.justice.gov/usao/pam/news/2012/Grimes_11_30_2012.htm viewed 30 November 2014. 68 Reich ES, “Duplicate-Grant Case Puts Funders Under Pressure” (2012) 482 Nature 146, http://www.nature.com/news/ duplicate-grant-case-puts-funders-under-pressure-1.9984 viewed 30 November 2014. 69 Qian L, “US Professor Hired in Nanjing Charged with Crimes”, People’s Daily Online (12 February 2012), http://english.peopledaily.com.cn/90882/7726577.html viewed 30 November 2014. 70 “Craig Grimes, Ex-Penn State Professor, Sentenced for More than $3 Million in Research Grant Fraud”, Huffıngton Post (30 November 2012), http://www.huffingtonpost.com/2012/12/03/craig-grimes-sentenced_n_2232658.html viewed 30 November 2014. 71 See Gray R, “Scientist Jailed for Faking Medicine Test Results”, The Telegraph (17 April 2013), http://www.telegraph.co.uk/ news/uknews/crime/10001149/Scientist-jailed-for-faking-medicine-test-results.html viewed 30 November 2014. 72 MHRA, “Pre-Clinical Trial Data Scam – First Ever Successful Prosecution under Good Laboratory Practice Regulations” (Press Release, 12 March 2013), http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON249630 viewed 30 November 2014. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 251 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton Jim Stephenson, the defence solicitor advocate representing Eaton, submitted that his client had been under pressure at the time and had been having trouble with his personal life. He asserted that Eaton had not gained financially from his conduct but the court was offered no motive for why Eaton had manipulated the data.73 In sentencing Eaton to the maximum term of imprisonment available (three months), Sheriff O’Grady said: I feel that my sentencing powers in this are wholly inadequate. You failed to test the drugs properly – you could have caused cancer patients unquestionable harm. Why someone who is as highly educated and as experienced as you would embark on such a course of conduct is inexplicable.74 Dong-Pyou Han In 2013, Dr Dong-Pyou Han was an assistant professor in biomedical science at Iowa State University. His area of research was directed toward discovering a vaccine for HIV/AIDS. The research team of which he was a member had received at least US$19 million in funding from the United States government.75 His research fraud was uncovered by scientists at Harvard University.76 It consisted of adding human blood components to rabbit blood to make it appear that a vaccine on which he was working was effective in fighting HIV. The falsified assay results were widely reported at national and international scholarly gatherings between 2010 and 2012, giving false hope for this direction in research.77 James Bradac, who oversees AIDS vaccine results for the NIH, stated that Han’s conduct was the worst case of research fraud he had encountered in two decades at the agency.78 The nature and the seriousness of Han’s conduct became apparent after an extensive investigation conducted by the Iowa State University of Science and Technology and the ORI. They jointly concluded that Han had falsified research materials by providing collaborators with spiked serum results, having faked the relevant data files. He made extensive admissions of his conduct and entered into a voluntary exclusion agreement for three years to exclude himself from eligibility for any federal research grants and eligibility for service on any advisory committee to the United States Public Health Service. He also resigned from the university. Before his resignation, Han allegedly wrote to the university, confessing to his conduct in 2009, explaining that he had engaged in it because he wanted the results to look better and saying, “I was foolish, coward and not frank”.79 Iowa State University agreed to reimburse the NIH US$496,000 for salary and other costs paid to Han. In addition, the NIH decided not to make the final US$1.38 million payment on a grant to the research team as a result of the conduct of Han. United States Senator Chuck Grassley questioned whether the NIH had responded strongly enough to what he asserted was “brazen fraud”.80 Arthur Caplan, a Professor of Medical Ethics at New York University, called for Han to be prosecuted in order to send a message to university officials 73 See Gray, n 71. 74 “Scientist Steven Eaton Jailed for Falsifying Drug Test Results”, BBC News (17 April 2013). 75 “ISU Researcher Dr Dong-Pyou Han Resigns for Faking AIDS Research Worth Millions”, Huffıngton Post (25 December 2013); Soltis A, “Professor Admits to Faking AIDS Vaccine to get $19M in Grants”, New York Post (26 December 2013). 76 Pitt D, “AIDS Scientist Dong-Pyou Han Pleads Not Guilty to Faking Study”, Huffıngton Post (2 July 2014). 77 Health and Human Services Department, “Finding of Research Misconduct in relation to Dong-Pyou Han”, https:// www.federalregister.gov/articles/2013/12/23/2013-30424/findings-of-research-misconduct viewed 17 August 2014; Office of Research Integrity, “Case Summary: Han, Dong-Pyou” (23 December 2013), http://ori.hhs.gov/content/case-summary-handong-pyou viewed 17 August 2014. 78 Lestch C, “Iowa Professor Cops to Faking Results of Big-Bucks AIDS Vaccine Research”, New York Daily News (27 December 2013). 79 Pitt, n 76. 80 Leys T, “ISU Loses $1.4 million in Fraud Case”, Iowa City Press-Citizen (8 July 2014). 252 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Editorial and researchers that fraud in such activities can be a criminal offence.81 By June 2014, Han had been arrested and charged on a four counts grand jury felony indictment of making false statements. He pleaded not guilty to the charges and, as of December 2014, was awaiting trial. Caplan’s response was to observe that, too often, serious ethical and legal violations by researchers can end up being settled privately without the public’s knowledge: I think it sends an appropriate message about research misconduct and misuse of taxpayer funds and the dangers that misconduct can cause to vulnerable patients. If you lie about research, you can wind up really harming people, because other people rely on your claims.82 Caroline Barwood In October 2011, Professor Bruce Murdoch, a neuroscientist at the University of Queensland’s Centre for Neurogenic Communication Disorders Research, and Dr Caroline Barwood, a speech pathologist, were two of the authors of a landmark study on Parkinson’s disease published in the European Journal of Neurology in 2011. A whistleblower alleged that there was no evidence that their research into Parkinson’s disease was carried out.83 The University of Queensland’s Vice-Chancellor asked the journal to retract the article and ordered an internal misconduct investigation by the university. The university was unable to identify any data to prove that the study was conducted and both academics resigned their positions at the university. The university returned the first two instalments of a A$300,000 bursary awarded to Barwood and the conduct of the two scholars was referred to the Crime and Misconduct Commission of Queensland (as it then was).84 The university then began to examine more than 100 published papers associated with the two academics. Media reported that concerns existed in relation to 11 papers published in seven journals, as well as one paper that had been wholly republished. The university referred its concerns to the editors of the various journals, resulting in early 2014 in the retraction of a study that had been published in Aphasiology. A retraction notice on the publisher’s website states the study claimed to have a control group of 15, but only seven participants were documented and control data were re-used to enlarge the group – “lack of independence within control data is not acknowledged in the manuscript”.85 In October 2014, Barwood was charged in the Magistrates’ Court of Queensland with two counts of fraud and two counts of attempted fraud contrary to s 408C of the Queensland Criminal Code and two counts of general dishonesty contrary to s 135.1 of the Criminal Code Act 1995 (Cth). The Crime and Corruption Commission stated that its “investigation remains ongoing and further charges are expected”.86 EVALUATION OF CHARGES PREFERRED For the most part, the criminal charges brought against researchers have been in the nature of fraud or obtaining financial advantage by deception. Such charges are well recognised and of longstanding on the statute books. Their essence is that the researcher has derived some form of benefit by the use of dishonesty – generally in respect of not undertaking bona fide research when they have obtained funding to do so. At its heart lies the making of profit of one kind or another and a serious breach of trust in the conduct of research. 81 Rodgers G, “Former Iowa State Researcher Indicted”, Des Moines Register (20 June 2014). 82 Rodgers, n 81. 83 Elks S, “Probe on Academics Uncovers New Concerns”, The Australian (21 January 2014). 84 “CMC Confirms Misconduct by Queensland Academics”, PM (ABC Radio) (7 November 2013), http://www.abc.net.au/pm/ content/2013/s3886274.htm viewed 30 November 2014. 85 Taylor and Francis, “Statement of Retraction” (2014) 28 Aphasiology 770, http://www.tandfonline.com/doi/full/10.1080/ 02687038.2014.908038#.Uz-0__2gFjM viewed 30 November 2014. 86 Crime and Corruption Commission, “University Researcher to Appear in Court in Fraud Offences” (Media Release, 31 October 2014), http://www.ccc.qld.gov.au/news-and-media/ccc-media-releases/university-researcher-to-appear-in-court-onfraud-offences-2014-31.10.2014 viewed 30 November 2014. (2014) 22 JLM 241 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com 253 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com Freckelton The exception in this regard was the charge brought in Scotland against Steve Eaton under the Good Laboratory Practice Regulations 1999 (UK). This was a somewhat obscure source of prosecutorial power that had the potential of only a minor criminal count. It was less than desirable. For the most part, the exercise of prosecutorial power in the cases that have proceeded to adverse findings has appeared straightforward. In each of the cases, the conduct was serious and the discretion to charge was exercised in a way that was unsurprising given the nature of the conduct and its foreseeable consequences to a variety of stakeholders. The penalties in such cases (mostly in the United States) have varied significantly: • Breuning (plea of guilty): 60 days in a halfway house, five years of probation, 250 hours of community service, repayment of US$11,352, and to abstain from psychological research for the period of his probation; • Van Parijs (plea of guilty): six months of home detention with electronic monitoring, 400 hours of community service and a payment of US$61,117 to MIT for money that had to be returned to the NIH; • Poehlman (plea of guilty): one year and a day in federal prison, followed by two years of probation; • Hwang (largely a contested hearing): two-year jail sentence, suspended for three years; • Reuben (plea of guilty): a six-month sentence of imprisonment; • Grimes (plea of guilty): 41 months’ imprisonment and repayment of more than US$640,000 in restitution; • Eaton (plea of guilty): a three-month sentence of imprisonment. For the most part, those charged, after negotiations, have pleaded guilty and have been sentenced to a period of imprisonment, varying from a period of time in a halfway house (jail in the community) to 41 months’ imprisonment. The period of incarceration has varied and will continue to vary depending on factors such as the extent of the period of offending, the sum involved and the degree to which the accused person has conceded culpability for their breach of trust. However, as yet it must be conceded that the number of cases available for analysis is very modest indeed and it is important to be cautious in extrapolating from their outcomes. Conclusions An evolution in responses from misconduct regulators (associated with prosecutors) is identifiable in recent years. Criminal charges are starting to be brought in a number of countries against those identified as responsible for egregious research fraud. This is justified. The harm done to those entities (government and non-government) which make research funds available to researchers is easily calculated. However, much more difficult to identify with precision is the damage done to patients who receive treatment when otherwise they might have received a better intervention or whose hopes are manipulated by deceit. In addition, co-authors, supervisors and whole areas of research can fall into undeserved disrepute as a result of the research fraud, and the reputations of departments, journals and publishing houses can also be adversely affected. While biomedical research, like much of professional practice, functions on the basis of trust and integrity, the commission of research fraud constitutes a gross abuse of such trust. Given that such conduct is engaged in by professionals who are well positioned to make considered choices about what they are doing, and to be cognisant of its consequences, there is much to be said for the criminal law being utilised. While there are limits to the efficacy of the criminal law as a deterrent, the imposition of clear findings of guilt, the recording of convictions, and the utilisation of stern sentencing outcomes, in combination have the potential to recognise the seriousness of research fraud and to go some distance toward deterring others from the temptation of engaging in it. Ian Freckelton QC 254 © 2014 Thomson Reuters (Professional) Australia Limited for further information visit www.thomsonreuters.com.au or send an email to LTA.service@thomsonreuters.com View publication stats (2014) 22 JLM 241 Please note that this article is being provided for research purposes and is not to be reproduced in any way. If you refer to the article, please ensure you acknowledge both the publication and publisher appropriately. The citation for the journal is available in the footline of each page. Should you wish to reproduce this article, either in part or in its entirety, in any medium, please ensure you seek permission from our permissions officer. Please email any queries to LTA.permissions@thomsonreuters.com