Author A has published approximately 150 original articles since ~1994, with ~100 on one particular topic. Since some of these events were up to 16 years ago, and there are no formal records from then relating to these studies, the only information we have is the memory of the editors of the affected journals in post at the time. According to their accounts, suspicions were aroused over the validity of the data, in particular the similarity between baseline data of some of the different studies. When author A was pressed to provide raw data, he stopped responding and stopped submitting papers to the specialty journals, switching to general journals where he continues to publish. The editor of one specialty journal raised concerns with the author’s institution (in another country) approximately 12 years ago; it responded saying it saw no reason to investigate further. A letter, published in one of the specialty journals in 2000 by an independent researcher, asked the question “Why are author A et al’s data so nice?”, pointing out that the probability of such results occurring by chance were infinitesimally small, but as far as we know there have been no formal investigations of author A’s work
Following an April 2010 editorial in one of the specialty journals about research fraud in general, that mentioned this particular author by name, a correspondent raised the lack of investigation into author A, stating that his update of a systematic review was being hampered by the (suspect) influence of author A’s work in this area. The current editor-in-chief of that journal contacted the current editors of seven other affected specialty journals, who until this point were largely unaware of the problem, or its extent, having not been in post at the time the papers were submitted to their journals. We have since been discussing the problem and possible courses of action. The points raised are:
(1) Regarding the older papers:
(i) the journals themselves do not have the ability to mount an investigation;
(ii) it is unlikely that an investigator, bona fide or not, will still have original data from the older studies;
(iii) it is unlikely that author A’s institution will be interested in investigating studies so old, and we think he might have moved universities since then;
(iv) currently we do not have any firm data of wrongdoing, just suspicions. Options for gathering more data include asking the original correspondent and the systematic reviewer to provide a more formal commentary, although we have not done that yet. Meanwhile, one of the editors has gathered data on all author A’s studies: there are 135 in which author A is the first author, reporting almost 12,000 randomised patients in 17 years. Most are with one of the same three co-authors. The largest group of papers (by topic) are all very similar in design, with very little variability in baseline placebo event rates, and generally similar results although the outcome measures differ and there are one or two ‘surprising’ (at best) findings. One particular drug features in 71 studies. Dropouts are hardly ever reported.
(2) Regarding the newer papers:
(i) these may be easier to investigate since the data should still exist;
(ii) we could contact the editors of the non-specialty journals (there are many, publishing just 1-2 of A’s articles each) to alert them but the problem of having only suspicions remains (compounded by the relatively large number of journals, each with a small number of papers);
(iii) we could ask a respected academic in author A’s country to make discreet enquiries of author A’s co-investigators, some of whom may not realise what is going on, or they may have concerns themselves. However, this could be a delicate situation for such a person. We would welcome COPE’s advice on how best to proceed.
The Forum was unanimous in their opinion that this should really be resolved by the researcher’s institution. Although there is no hard evidence, it was suggested that all of the journals, as a team, approach the institution and ask the institution to conduct an investigation. It was felt that this would provide a more powerful case than a single editor on his own. Meanwhile, the editor should try and gather more evidence, perhaps by contacting the ethics committees who supposedly approved these studies. The editor may then be able to determine whether in fact the studies took place as reported. The Forum advised against informing the non-specialty journals at this point as there is no real evidence at this point, so it would be difficult for them to know what to do. The Forum also suggested that the editor should advise anybody doing a meta-analysis on this subject to include a sensitivity analysis to test the effects of including the data from these studies.
The group of editors-in-chief are planning on sending a letter to the author and the institutions. The delay has been in obtaining an independent analysis of the suspect works, which so far indicates that the likelihood of fabrication is very high.
Follow up (May 2011):
The editors are still planning on sending a letter to the author and the institutions but this has been delayed pending the analysis, which has now been submitted to journal A for publication! (It concludes that fabrication is almost certain.) Meanwhile, a separate publication scandal has distracted the editors’ attention recently.
We did not investigate ethics approval since we felt that should be for the institution to investigate. My main question is what to do with the analysis that has been submitted:
(i) process as usual and publish if accepted (after discussion with/approval by the publishers); that is, let the author/institution respond if they wish (ii) present it to the suspect author (with the analyst’s permission) and remove from the publication process for the time being (iii) present it to the suspect author’s institution(s) as per (ii) (iv) present it to the suspect author and institution(s) as per (ii)
I have sought an independent statistical review of the analysis from a respected statistician but have not had a response.
Advice on follow up:
There were various views on how to proceed in this difficult case. Some agreed with sending the analysis to the institution and the suspect author, at the same time, informing them that the intention is to publish the analysis in the journal, and then see what type of response this elicits. Others disagreed and recommended treating the analysis like any other submission (despite the fact that the review was commissioned by the journal and the editor hadn’t originally intended to publish it) — send it out for peer-review and publish it in the normal way. Most agreed that a copy of the analysis should be sent to the institution, either before or after peer-review. But the paper does not need to be peer-reviewed before it is sent to the institution.
The Forum also advised consulting the journal’s legal department before going ahead with publication.
A manuscript was submitted to our Journal in 2008. The six authors signed the author form for the Journal which accompanies all submitted manuscripts. The author form gives information on the role each author played in the study and states that each author has read and approved the paper for submission to the Journal.
Following peer-review the paper was accepted for publication. It was published in February 2009. In October 2009 the Journal received a letter from the corresponding author who asked for the paper to be retracted. The corresponding author stated that the first author had used data which was originally generated by a student working in the department (permission had been given to the first author to use the data) but that the data presented in the paper were different to the data published by the student in a thesis. The corresponding author further stated that the first author was being investigated by the university in which the research took place and by the Ministry of Education.
The Editor-in-Chief of the Journal and the Publisher wrote to the corresponding author and said that they would wait until the investigation by the university and Ministry of Education had concluded before deciding whether the paper should be retracted. The corresponding author responded to this letter and asked that the paper be retracted immediately and stated that the investigation would take several years.
The Editor-in-Chief and the Publisher then wrote to the first author and asked for a full and detailed explanation as to the concerns raised by the corresponding author. The first author responded and said that the dataset for the paper was extracted from a patient database which contains information on patients treated at the university. Datasets from several sources were used to update the main database and information was extracted based on the inclusion criteria outlined in the paper. The first author stated that she had identified more patients who fitted the inclusion criteria from the database than the student and this was the reason for the discrepancy in data between the thesis and the paper published in the Journal. The first author also told the Journal that the corresponding author had brought the discrepancies in the data to the attention of the Ministry of Education, the university's Academic Ethical Committee and the Faculty Appeals Committee. The first author says that these groups have accepted the reasons behind the discrepancies in the data.
The Editor-in-Chief and the Publisher also wrote to the co-authors of the paper (four co-authors, excluding the first author and the corresponding author). Three of the co-authors have responded and state that they accept the reasons behind the discrepancy in the data produced in the original project and the data used in the paper. In addition to writing to the co-authors, the Editor-in-Chief and Publisher informed the corresponding author that they were contacting the co-authors. The corresponding author responded and said that the paper should be retracted immediately and that he was considering whether to publicly announce that the paper should be retracted from the Journal.
The Journal would appreciate advice on how to proceed.
The Forum commented that it was unusual for an author to criticise his own paper. The Forum suggested asking the corresponding author to write a letter detailing his concerns that could be published in the journal and then his co-authors would have the chance to comment on the letter. Other advice was to contact the institution and ask them about their investigation and how long it will take to complete. The institution should be approached in neutral terms asking them to confirm the corresponding author’s claim that the investigation will take several years. The Forum believed that the editor is not in a position to do anything else at the moment.
Following the COPE meeting, we were informed by one of the authors involved in our case that an investigation had been launched to examine the allegations surrounding the data used in the paper. We wrote to the authors and asked for details of the investigation, particularly the contact details of the person chairing it. We received confirmation that the investigation is being coordinated by the research ethics committee of the university where the authors are based and have written to the chair of the committee and requested a report of their conclusions once the investigation has been completed. We have not yet heard back, although the letter was only sent recently. We have also let the authors know that we have contacted the research ethics committee and will wait on the findings of the investigation before proceeding any further.
Follow Up (December 2010): The editor received no response from the authors' university and no response from the complainant (who was also a member of the author team). Therefore, the journal did not retract the paper and it continues to stand. The editor considers the case now closed.
We published a randomised trial by six authors. Some years later, we received a letter from a researcher who had been looking into the trial in the context of a meta-analysis. She noted “implausibilities of serious concern”, including “a highly unusual balance in the distribution of baseline characteristics”, 95% CIs that were non-symmetrical about the effect estimate, and use of a stratification variable the value of which could not have been known in all patients if the trial was conducted in the way reported.
We asked the corresponding author to write a letter of response, which he eventually supplied a few months later. Owing to the author’s poor English and the level of statistical knowledge needed to assess the response, we sent the exchange of letters to a statistical reviewer. The reviewer said that the letter of concern was “completely correct” in everything it said and that the author’s explanation for the unusual degree of balance in the covariates was “rubbish”, and that the 95% CIs had either been “doctored” or “incompetently estimated”.
In the meantime, an exchange of to-and-fro letters between a different researcher and the same author was published in another journal, relating to a paper reporting on a subset of the same trial data. We were alerted to this by the editor of that journal.
We sent the reviewer’s remarks to the author of our trial, who then consulted two independent statisticians of his own. He soon contacted us to say that, “surprisingly and regretfully”, these statisticians agreed that there were implausibilities and inconsistencies in the data, and asked for more time to investigate more fully. During this time, the author of the letter expressed concern that we had not made the possibility of these problems know to our readership, so we published her letter.
The author has now sent us a more comprehensive response, admitting that the randomisation process was not as described, the 95% CIs were all wrong (he supplied a recalculation), and the trial report had omitted some details of the protocol necessary for understanding it properly (now supplied). Our reviewer suspects that, given his free admission of all this, the author is probably incompetent rather than fraudulent, but that the extent of the incompetence could not give us confidence in any of the data. What now?
The Forum agreed with the editor’s opinion that the author is probably incompetent rather than fraudulent and should be given the opportunity to redeem himself. It was suggested that perhaps the paper should be submitted for review again. The Forum noted that this was probably a good internal learning exercise in that the statistical errors should have been picked up when the statistical review of the data was performed by the journal. A suggestion was made for the journal to set up a “sin bin”. Some journals operate a “sin bin” or “publication review committee” where once a year papers which readers or others have expressed serious doubts about post-publication are reviewed to determine whether or not it was “a mistake” to publish the paper.
However, some members of the Forum argued for stronger action and suggested contacting the author’s institution. But most agreed that the paper should be retracted as the research may be unethical.
August 2008 We have managed to find details of whom to contact regarding informing the author's institution, and the deputy editor has written to him. We await a reply with anticipation.
May 2009 The institute has responded to say that an investigation is under way and will take another couple of months to conclude.
November 2009 Following an internal investigation by the author’s institution, a number of serious problems were encountered, including: lack of ethics approval, lack of written consent, lack of treatment-allocation concealment and an inability to verify the authenticity of the data. We therefore retracted the paper on 10 October 2009.
A paper was submitted to us describing an RCT carried out in a Far Eastern hospital. Soon after the manuscript had been sent out for review, one of the reviewers sent a letter alerting us to a “possible case of fraud”. The reviewer in question appears to have compared notes with another investigator in his institute, and together they realised that the same group had submitted two similar trials to two different journals (without enclosing the related paper in their submission to us).
There is ambiguity here, but we believe that the allegation is one of fraud (Do the patients really exist? Are the two groups of patients overlapping?) rather than duplicate publication.
We challenged the authors, asking them to send us the related manuscript and protocol. This they did very willingly, and they sent files of primary data too.
The authors then withdrew the related paper submitted elsewhere. Although this seems suspicious, it seems that the authors thought we would be less favourably inclined to the paper they had submitted to us if a related paper from them was accepted by another journal first.
Review of the paper submitted to us proceeded, although the individual who had alleged fraud did not send a report.
Sufficient technical criticisms were raised to justify rejecting the paper, in our opinion. However, as far as we know, independently, one of the other referees commented “somewhat puzzling are the exceptionally well balanced, perfect patient characteristics in table 1”.
We have now rejected the paper in question. We would like COPE’s advice on what to do further—we are open to persuasion, but are not sure that there is sufficient evidence of wrongdoing to ask for an institutional investigation. We have not yet responded to the reviewer who raised the initial allegation of fraud.
The Forum questioned the idea of requesting an institutional investigation in view of the fact that there is no clear evidence of wrongdoing. Also, would the investigation be conducted properly and would the authors receive a fair trial? Others questioned whether it would be a sensible use of editorial resources. The Forum suggested that as the authors are aware that the editor has raised suspicions regarding the paper, that may be sufficient warning for them. Other advice was to contact the reviewer explaining that it is not good practice to compare notes with other investigators as such material should be treated as confidential.
The paper was rejected and the editor decided not to try to initiate an institutional investigation owing to insufficient evidence of wrongdoing. Later the editor heard from the refereeing “whistleblower” (who had written to the editor to allege “possible fraud”) that the same paper had been accepted at another journal, and that he had been invited to write an editorial. A couple of weeks ago, the editor heard from the same “whistleblower” that the other journal rejected the paper and were considering an investigation. The journal is no longer actively involved in pursuing this matter.
A general medical journal received an RCT from a seldom-published, single-author, in an eastern European country. The results were striking, with an effect size that surpassed that of established medications for this condition, so the manuscript was sent for peer review. One reviewer commented that the results were “so highly statistically significant it is almost too good to be true. Virtually every parameter was observed to be statistically superior in the [intervention] group”.
On closer inspection, a number of concerns arose regarding recruitment, inconsistencies and reporting.
The author denied fabrication, but the editors were not satisfied with his explanations. The manuscript was rejected and the journal approached the institution’s ethics committee, and then the director of the institution, who undertook an investigation.
The internal investigation reported that the author looked after many patients with the condition, some of whom were contacted and affirmed that the intervention was beneficial. The statistical analysis was confirmed by a university in the USA. The investigators believed that the conclusions were true and that there was no evidence of misconduct.
Does COPE have any comments or suggestions regarding the journal’s actions?
The Forum felt that as there was no evidence of misconduct and the editor had pursued all of the usual channels of investigation, there was little more that could be done. Some suggested obtaining the raw data and seeking expert advice from a statistician, although that may not be possible as the journal rejected the paper. All agreed that the editor had taken all of the appropriate steps and possibly gone as far as he could with this case.
At COPE’s sensible suggestion, the editor requested a copy of the external report vindicating the analysis, but this was not available. Although not satisfactory, the editor considers the case now closed.
The editors of this journal check all articles against Medline for possible redundant publications. Two very similar articles from an author were retrieved when the name of the author was searched. The titles were very similar, except for the name of the disease. The abstracts had almost 50% identical wording. The two articles were not related to the article submitted to the editors, but as they came up with such similarity, the editors looked them up, interested more as scientists and colleagues from the same university.
The editors found that the control groups were identical, but there was no cross referencing between the two articles, although they were published more than two years apart. The same controls were used for two different diseases, one more prevalent in women, the other in men. Finally, although the main point of the articles was measuring concentration of a substance in healthy subjects and patients, there was not a single value of the measurement. The only numbers provided in the tables were the results of the Mann–Whitney statistical test.
Surprised by such data presentation, especially because one of the journals was a respected journal from the editors’ country, the editors wrote to the editors of the two journals in question, and then to the head of the institution, explaining how they had learned about the problem, and asking for an explanation. The journals never replied. The institution head replied in quite a rude way, enclosing a letter from the authors, who wrote that they saw no problem because the papers had been through a peer review in respected journals. They stated that they originally submitted real numbers, but the reviewers asked for simplification of the tables (ie, taking out the actual values of the measured variables). The editors wrote to the journals again (twice), asking them to clarify this, but still did not get any answer.
The editors would like COPE’s advice on how to proceed?
As the papers in question were not from the editor’s own journal, the Forum reasoned that really the editor is in the position of whistleblower. The advice from the Forum was to submit a letter detailing the issues. In this way, even if it is rejected for publication, the editor will have to respond in some way and the matter will be in the editorial system. If the letter is rejected, then the editor can decide to appeal. If the editor still feels dissatisfied with the editor’s response, another suggestion was to contact the editorial board of the journals and then the publishers.
Although this case did not directly concern the editor’s journal, the editor felt is was necessary to pursue the issue because of its importantce to the scientific community in his country.
After several inquires, the editor received a response from the authors who stated that the reviewers asked them to remove data and only give statistics. The editor asked the editors of the two journals to provide him with the reviews but a reply was never received from the editors of either of the journals. As all of the authors are from the editor’s country and and one of the journals is an international journal from the same country, the editor has asked advice from the National Board for Ethics in Science and Higher Education, which has a mandate to investigate cases and give opinions to the Minsitry of Science, Education and Sports. The editor is currently awaiting their response.
May 2008 The National Board for Ethics in Science advised the editor to send the case to the University Ethics Board, as this is the next step after his appeal to the deans of the Medical and Dental Schools. The editor did not get the formal letter from the National Board for Ethics, but their decision is available online, in the annual report of the Board to the Parliament. The editor plans to follow the advice from the National Board for Ethics. The case continues.
August 2008 The editor received a reply from the National Board for Ethics in Science that he has to first bring this case to the University Ethics Council, before they (the Board) can give their opinion. The editor then sent the case to the University Ethics Council. The editor is awaiting their answer.
A paper reported a radioisotope test for diagnosis of a speci?c,acute,neurological disease with 100% accuracy. Replication studies failed to con?rm the ?ndings and suggested that the test is positive in about half those affected and in a similar proportion of normal controls.Other publications by the same authors produced results at variance with their claims and misreported their ?ndings. One author admitted that the data had been altered to show a better result. An earlier publication from the same department described another isotope test for detecting an unrelated disease with 100% accuracy. It was later proved to be without value for the diagnosis of that disease.
The allegations of unethical experimentation
The study involved injection of a large dose of isotope into patients with acute neurological injury, in whom cognitive function was likely to be impaired. There was no mention of ethics approval or informed consent. The authors later stated that approval was not required because the test was used for clinical management. There was no previous or subsequent publication demonstrating clinical utility. The employing authority was therefore asked to explain how the test could have been used for clinical management. They replied that it was only a preliminary study. When it was pointed out that such a study would require ethics approval,they stated that this had been obtained,although they had not mentioned this in the paper or subsequent correspondence. When asked to provide a copy of the approval form, they threatened legal action. It is believed that the institution did not have appropriate approval to administer the isotope.
Attempts to silence the whistle blower
The whistleblower failed to replicate the observations and noted discrepancies in other papers by the same group.He contacted the patients involved in the study.They described events at variance with those of the published paper and produced documents to prove it. He challenged one of the authors who admitted that data had been altered to give a perfect result. The whistleblower approached the institution and asked for an investigation. Shortly afterwards he was told that an internal enquiry had found no cause for concern. The whistleblower asked why he had not been asked for the names of the patients who disputed the events described in the paper or asked to produce documents. He was threatened with legal action and expelled from an MRC committee on which he sat. The committee chairman was one of the authors of the disputed study.The institution blocked a request from the whistleblower to use information on a national database which is managed,but not owned,by the institution:the database is theoretically open to all investigators in the ?eld.
Having received no satisfactory response to his request from the head of the institution,the whistleblower approached the journal which published the paper, requesting that the journal publish a paper from him explaining that there had been scienti?c fraud and unethical experimentation,followed by a response from the authors. The editor felt that there was a case to answer and asked the authors of the original paper to respond. The editor copied the request to the head of the institution.
The head of the institution, instead, referred the whistleblower to the GMC for disparagement. The GMC investigated the whistleblower for eight months before he was exonerated and the focus of the investigation turned to the authors.
What should the editor do now?
The institution must produce evidence of the investigation.
The editor should refer the authors to the GMC if they are registered because there are legitimate doubts about the ethical procedures for this study.
A copy of the referring letter should be sent to the head of the institution.
A randomised controlled trial was submitted, showing that a new treatment, which is a combination of familiar compounds, is highly beneficial in a common but largely untreatable problem. The authors came from several different countries and included people from the company that manufactures the treatment. The editors had great difficulty finding reviewers for the paper as many simply returned it, saying that they could not produce an opinion. The reviewer who did eventually do so said that the results were not credible and that all the signs suggested that the paper might be fraudulent. The statistical adviser was asked for his opinion, and, although he agreed that the results were very unlikely, he was less convinced that there had been any data manipulation. He suggested that the editors request the raw data. The editors were unsure what to do at this point. Their previous experience of asking for raw data was that it involved a highly complex and very expensive exercise. They wondered if instead they should simply alert the authors’ employers—there are six different employers from four different countries—and ask them to investigate. The editors almost certainly did not want to publish the trial.
_ The editor should write to the authors saying that a reviewer has expressed some concern about the data. _ Request the raw data from the authors, specifying that it should be in an electronic form.
The editors rejected the paper but also requested the raw data. The authors have submitted the raw data on CD and these are currently being analysed by a statistician.
A manuscript was received from a group of authors who had not submitted to the journal in question before. The review was extremely critical and the paper was rejected. In a covering letter the reviewer said that not only was the experimental design flawed, but he was also convinced that the experiment described had never been done. He had scanned Medline 1997–2001 and found seven other papers with the same first author each of which had a similar protocol, but in each case had used a different nutritional supplement. All the studies had been conducted on groups of 40 subjects who were given either a supplement or control substance over a period of one year. This implied that the authors had recruited over 300 subjects for these studies, which was hard to believe. The entry criteria for the study meant that the pool of eligible subjects was small, and the protocol was rigorous, not to say unethical, so it would have been difficult to have obtained informed consent. What, if anything, does COPE suggest be done to investigate the suspected fraud?
_ As the paper had been rejected, it would be difficult to obtain further information from the authors. _ Make the authors aware that the reviewer had expressed concern and ask them to provide further evidence, but not the raw data. _ The reviewer should not be involved, and any concerns being raised should come from the editor, not the reviewer. _ In view of the seven other published papers, the editor would need to establish whether this was a prima facie case before contacting the other journals. _ Write to the authors, but if no reply is received then contact he head of the institution. _ Due to the serious nature of this case, impose a time limit, of say, four weeks, to obtain a response.
No reply had been received from either the authors or the heads of their institutes. As the paper has already been rejected, and the editor has now retired from the journal editorship there is very little leverage to make them reply.
A journal published a paper several years ago that subsequently had to be retracted, on the advice of the university where the work had been conducted. The university provided no further details but promised to do so. Two years later they confirmed that the paper should be retracted, but gave no information on exactly what had gone wrong and whether anybody had been punished. Subsequently, one of the authors wrote to the journal expressing concern that no fuller explanation had been offered. He suggested that he was innocent and that one of the authors of the paper was clearly guilty. He said that the retraction did not make clear whether all the authors were equally guilty, and he wanted a retraction published that put this to rights. What should be done next?
_ The problem was clearly between the author and the university and the editor was being asked to intercede on his behalf. _ It was unclear what more the editor could do; he is certainly not in a position to conduct an internal enquiry. _ How much information needs to be obtained before a paper is retracted? _ If an author had been struck off by the General Medical Council (GMC) then a notice should be published. _ See whether all the authors had signed the covering letter on initial submission to the editor. _ Write to the head of the institution, suggesting that an internal enquiry be carried out.
Not all the authors appeared to be equally guilty; one had been referred to the GMC.