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Rapid Responses: Rapid Responses published:
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TIME FOR INTERNATIONAL RESEARCH REGULATORY BODY
- DEV SRIVASTAVA, S.Dev (30 July 2005)
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Scientific misconduct- suspicion and action
- V Raman Kutty (1 August 2005)
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Drum out the Myth Makers
- Tom A Braun (1 August 2005)
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Public Data?
- J A Delaney (2 August 2005)
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The use of systematic reviews for editorial peer reviewing: a population approach
- Iain Chalmers (3 August 2005)
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Sentencing for scientific fraud: is punishment enough?
- Cathy Popadiuk (3 August 2005)
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Basis for research
- Oliver R Dearlove (5 August 2005)
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Research needs policing
- Sashidhar Yeluri, Guneesh Dadayal (26 August 2005)
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DEV SRIVASTAVA, SHO Prince Charles Hospital,CF47 9DT, S.Dev
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Dear Editor, There is no doubt after reading the article that the doctor in question has a tremendous desire to do research( refer to the prolific numbers of papers in a short span of time).Anybody who wishes to extend the vistas of human knowledge should be welcome.However using dubious data to achieve those ends can only be condemned and no amount of research enthusiasm can obliviate that. Maybe its time to have an international medical research commision with punitive powers exercised through the UN/WHO to regulate worldwide research.Its first step should be to reduce the number of medical journals to manageable levels and secondly to prioritise broad areas of research to maximise the use of current world resources to improve the quality of human life. Dev Srivastava Competing interests: None declared |
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V Raman Kutty, Vice Chairman, Health Action by People Trivandrum 695024 India
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Your report on the investigation of misconduct following the paper by Singh and others published in 1992 will come as no surprise to the research community in India; rather, we are surprised only that it took so long. The medical circles in India have had a healthy scepticism about the prodigious output of this group of authors- so much so that it has led to cynicism among Indian clinicians about any research conducted in India. Some of us who have looked closely at some of the other papers of the same group of authors have been stalled in our efforts to point out discrepancies, at best being limited to a letter to the editor. What is perhaps more revealing is that they have managed to get 'research collaboration' from an extensive network of international scholars. This points to the urgent need for all scientists across the globe to be very careful who they associate with, in their mad rush to see their name in print. Competing interests: None declared |
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Tom A Braun, Pharmacist Retired 60056
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Dear BMJ, About 5 years ago, a paper was published in the US that stated that 85% of all scientific studies lacked the scientific unbiased rigors of medical research. That means only 15% of the studies were objective and unbiased. Currently, we are seeing a rash of studies discrediting nutritional supplements being published. When authors pick and choose the data or the population they want to support a predetermined conclusion of a clinical study, I think it is time to drum the myth makers out of the medical arena. The only purpose of such studies is to create an economic windfall for someone or some manufacturer. Honesty and truth has to be returned to the medical research community worldwide. Thomas A. Braun RPh Competing interests: None declared |
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J A Delaney, Satistician Department of Clinical Epidemiology, Royal Victoria Hospital
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In their recent article about scientific misconduct, Smith and Godlee discuss a number of options for reducing the risk of falsified study results (1). One idea that they mention is the depositing of data into a secure archive for purposes on auditing. It would, for example, have made the process used to evaluate the unpublished study much easier of the original electronic version had been given rather than the data having to be re-entered by hand (2). Depositing the data in a secure location also helps ensure the preservation of the data in case questions later arise about unexpected risk factors that were not considered at the time but which the data might shed light on. Obviously recently published data needs to be kept strictly confidential as secondary studies are an important part of a clinical trial. It is only reasonable that those who put the effort into running this trial should have the first opportunity to fully investigate the data. However, if the data eventually become public domain (after a sufficent waiting period) it would be of great help both in further understanding the results of key trials but also in providing a solid backdrop of data for meta-analysts and biostatisticians to develop techniques on. What time period is appropriate is an open question but clearly this could be resolved. Smith and Godlee dismiss this idea because of the lack of current infrastructure. Howevert, given the potential benefits in in increasing our understanding of these results, could we not develop this infrastructure? JA Delaney
1. Smith J and Godlee F. Investigating allegations of scientific misconduct. BMJ. 2005;331(7511):245-6. 2. Al-Marzouki S, Evans S, Marshall T and Roberts I. Are these data real? Statistical methods for the detection of data fabrication in clinical trials. BMJ. 2005;331(7511):267-70. Competing interests: None declared |
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Iain Chalmers, Editor, James Lind Library James Lind Initiative, Summertown Pavilion, Middle Way, Oxford OX2 7LG
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The title of this response to the editorial by Jane Smith and Fiona Godlee (1) is the title of a chapter by Tom Jefferson and Jon Deeks in an excellent BMJ book on peer review in health sciences edited by Godlee and Jefferson (1). The chapter makes the important point that, until proved otherwise, each report of an individual study submitted to a journal should be seen as one member of a population of studies addressing the same or similar questions, and that it should therefore be assessed by reference to other members of that population of studies. I know that I am not alone in having had experience of detecting previously unsuspected fraud in the course of preparing systematic reviews (3). And indeed, in her article reviewing the suspicions that research reported by RB Singh might be fraudulent, Caroline White notes that external reviewers had observed that one of Singh's reports suggested "a more striking total benefit than most previously reported trials", and that another was "not consistent with the literature'.(2) The BMJ deserves credit for having asked authors submitting studies to the journal to be explicit about 'what is aleady known on this subject'. It is my impression, however, that this requirement is usually not addressed in a sufficiently systematic way. If journals were to require authors to show by reference to scientifically defensible reviews of existing evidence why they had embarked on a new study, not only would it be likely that the relevance and quality of research would improve, but also that questionable and frankly fraudulent research would be detected more often. Yours Iain Chalmers References 1. Smith J, Godlee F. Investigating allegations of scientific misconduct. BMJ 2005;331:245-6. 2. Jefferson T, Deeks J. The use of systematic reviews for editorial peer reviewing: a population approach. In: Godlee F, Jefferon T, eds. Peer review in health sciences. London: BMJ Books, pp 224-234. 3. Howell C, Chalmers I. A review of prospectively controlled comparisons of epidural with non-epidural forms of pain relief during labour. International Journal of Obstetric Anesthesia 1992;1:93-110. 4. White C. Suspected research fraid: difficulties of getting at the truth. BMJ 2005;331:281-8. Competing interests: None declared |
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Cathy Popadiuk, Graduate Student Faculty of Law, University of Toronto, M5S 1A1
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According to Brian Martinson of the Health Partners Research Foundation in Minneapolis of 3247 mid and early career one in three scientists confesses to having “sinned”. 1.5% admitted to serious falsification or plagiarism, 15.5% changed study design methodology or results in response to pressure from a funding source, 12.5% admitted to overlooking others use of flawed data, 7.6% circumvented minor aspects of requirements regarding the use of human subjects. (Nature Vol 435, pp718- 719 June 9, 2005) Research has arguably become more complex in our globalized world where information can be shared almost instantly with networks and teams across the globe. In this context of efficiency and speed, financial resources seem all the more scarce. Channeling funds away from research to administrative endeavours such as research oversight is a hard sell particularly to professionals who are self regulating and consider themselves to work under the highest of scientific integrity. Yet as outlined in the article, numerous high profile cases have been brought to light for public scrutiny. Tremendous time consuming and laborious efforts were undertaken by the BMJ staff to describe the difficulty to get to the truth. It is frightening at how pervasive this problem has become. In a recent review, Martinson and colleagues of Minneapolis have documented through a survey of 3247 early and mid career scientists that one third confessed to “having sinned”. Of these scientists, most of the research infractions included changing study design methodology or results, and overlooking others’ flawed data. But 1.5% of respondents, admitted to serious falsification or plagiarism. But is punishment of the fraudulent miscreants enough? And what type of punishment? Banishment from science forever, confiscation of research funds and resources for some defined time period, expulsion from an institution with the risk of being hired elsewhere given impeccable credentials that these powerful miscreants tend to have? The satisfaction of irrefutably proving serious fraud and purging the falsehood contrived from the literature is a goal. Is there a role for rehabilitation and education through an organizational systems based approach? Education of the scientific method to students from A level teenagers to professors emeriti, in the context of modern pressures of commercialization in a “publish or parish” milieu, may not achieve the immediate satisfaction of irrefutably proving a fraud, but may begin addressing problems festering in our scientific community. By painstakingly drawing attention to this problem, in the final analysis may the BMJ articles motivate the necessary institutions and organizations at all levels from University and hospital to national bodies to contribute to finding solutions to this global problem of research fraud. Competing interests: None declared |
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Oliver R Dearlove, Consultant Anaesthetist Royal Manchester Children's Hospital
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Chalmers makes an interesting suggestion about the relevance and quality of research but there is no evidence that what he suggests - asking authors to cite scientifically relevant reviews as the genesis of the idea for their papers, would work. It is an interesting question for someone who is in the forefront of evidence based practice -does he have any evidence that his suggestion would cut fraudulent research ? The idea could certainly be tested in a randomised control trial. There could be a cited review arm and a “I thought of it in bed” arm and the end point would be whether either arm had more scientific fraud. His final hurdle would be securing permission to carry out such research considering there is no basis in reviews for such a thing. I don’t think that extraordinary results are more likely to be fraudulent. A moment’s thought means that they are sui generis more likely to be reinvestigated, verified and pondered over. I think fraudulent results would be more likely to be incrementally different to others to avoid attracting attention and detection, just a little bit different so as to make publication feasible. The fact that fraudulent results which are also statistical outliers are easier to detect is not the answer to the question. This is an opinion – I have of course no evidence for that assertion. The underlying theory of an idea having been seeded by other research attracted me as it is consistent with C J Jung’s ideas of group consciousness. This concept itself has recently attracted some attention but no observational proof. The grave disadvantage of requiring people to cite research that triggered their own observations is that scientific revolutions, rare as they are now, could never happen. Newton would not have been able to cite research leading to gravitation. There was, as far as I recall, none. He performed a thought experiment on the subject in 1666 with an apple in the grounds of Woolsthorpe Manor. Such a thing would hardly cut ice at the Royal Society - “I thought of it after an apple fell on my head”, nor Leibnitz’ invention of calculus which he did in a few months around May 1676. Einstein could not have printed his theory of relativity. Nor Godel his incompleteness theorem, as the view then prevailing in the 1930s was that David Hilbert’s 24th problem was provable and arithmetic would probably be shown to be complete. Godel’s paper was a thunderclap refutation. The advantage of such a scheme is that the old and crotchety would maintain a stranglehold on the direction of research and publication of results and the young world and its thought would forever be shut out - is this what we want? Oliver Dearlove Conflict and coincidence – or possible synchroncity – editorial 5 Aug 2005, in the Daily Telegraph on scientific consensus, who should lead research and the Royal Society – “Heated scientific climate” Competing interests: as script |
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Sashidhar Yeluri, SHO- BST Rotation St. James's University Hospital, Leeds LS9 7TF, Guneesh Dadayal
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The article on fraud in medical research was deeply disturbing. Without pointing any fingers, fraudulent research affects health care and mankind in many ways direct and indirect. A good study forms the primary basis for future research and propels the way forward. False research means a waste of precious and scarce research resources, a waste of manpower for hard working researchers involved in secondary research based on a faulty primary and most of all poor and indeed potentially harmful health care delivery for our patients. We indeed set the clock backwards by publishing ‘dangerous’ articles in the world’s leading journals e.g. the BMJ. Publication in these premier journals actually authorizes and guarantees the research. Leading journals of the world cannot be absolved of their errors. We think cooked up research has to taken most seriously. A few suggestions include setting up a central database of blacklisted authors (and co-authors), compulsory submission of raw data once the paper is accepted by the journal, and reducing the number of journals available on any particular subject (which we believe is the most impossible task!). Institutions can also be held responsible for assuring the quality of research submitted under its name and using its funds. Guilty institutions could also be blacklisted. Many people may not agree with the policing. Unfortunately, however, we are not living in a fair world. We are sure the BMJ can take a lead in setting up this central database. At least the leading journals of the world can join up to make this concept of medical Interpol a reality. Silly and potentially harmful articles will continue to get published in the local journal of silly articles. Who cares? Competing interests: None declared |
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