The authenticity of the content of numerous publications by Author K has been questioned by ‘concerned researchers’ in an anonymous email sent to the Editor of Journal A in December 2009.
The email noted that author K had been publishing articles in numerous journals that “report remarkable findings that watching humorous films, drinking deep-sea water, exposure to road traffic, cell-phone noise and radiation, kissing, playing computer games, listening to Mozart, infant suckling, sleep deprivation and starvation all affect various [physiological] responses.” Few of K’s findings have been replicated by other authors and the ‘concerned researchers’ were clear that they believe the findings to be unusual and the research based on improbable hypotheses and mechanisms.
The data presented in each of the articles are remarkably consistent ‘and, to be frank, seem too good to be true’. Most of these articles have been published by author K as a single author, and for a lone researcher the output is prolific.
The concerned researchers, the editorial office for Journal A and colleagues from the publishing house have all attempted to find an institution that author K may be affiliated to. There are suspicions surrounding author K’s affiliations to two institutions. When the author’s name and the two institutions are typed into a search engine, a lot of references to very similar articles appear in the search results.
The ‘concerned researchers’ therefore “cannot help but question whether the data presented in these articles are genuine. If not, this appears to be a case of scientific misconduct that could have far-reaching implications [in the field] … . This is ongoing, with nearly 100 articles published over the last few years including some published this year (2009)”.
Journal A published a paper by author K in 2004 which, taking into account the summary above, could have easily been fabricated from the perspective of the editor of the journal. The editors and the concerned researchers wish to know more about the legitimacy of these publications and whether the articles by author K are reliable.
The Forum suggested that if the author’s institution cannot be found, the editor could report the author to the General Medical Council or the equivalent medical licensing authority in the author’s country. The Forum asked if the editor had tried responding to the anonymous email. There is little that the editor can do without substantive evidence. He could respond to the anonymous email, asking for more information and emphasising that strict confidentiality is assured. The Forum noted that the editor has a duty of care with regard to the journal’s published papers. The editor should contact the reviewer(s) of the 2004 paper that was published in his journal and ask them to look again at the paper. Other advice was to contact the other journals where the author has published as they may have some information that would lead to the author’s institution, which should be contacted if possible. The Forum advised the editor to be alert to any more papers that come in from the same source.
Following on from the COPE Forum, I took on COPE’s advice and contacted the other editors that were listed at the end of the anonymous email that our editor received. There were 12 other editors and journals listed in this email, from a wide range of publishing houses. I have received five responses so far. One was apparently not aware of the email ever being sent. One asked a colleague to respond to my message, which I am still waiting for.
Three have expressed concern about the nature of the email; one of these editors has offered to judge the papers of the suspected author and provide a response, and I am waiting to hear back from them. One of the editors contacted a colleague who lives in the same country as the author and received a general response from their colleague who claims to know of the author and mentioned that the author ‘is known for [their] unique treatment’. However, this colleague noted that “I am not personally an acquaintance with [the author]. I just heard from some colleagues that many of [the author’s] works seem to be fake or fabrication, although I do not have any evidence about it”.
One editor responded with a lengthy email where they mentioned they have had discussions with the other editor of the journal and administrative staff at the publishing house. The editor noted that “ My personal view was that we should go ahead and ask the people who made the allegations to give in confidence their names so that we felt that there was a legitimacy to proceed with the inquiry that was clearly needed by virtue of the allegation”. However, the editor was not successful in obtaining personal identification from the anonymous email authors. The editor goes on to say that “At this point, our views are split. My view is that there was enough of a basis and concern given the subject of anxiety by the authors of the email about being victimised as whistleblowers. I thought that an open ended question to the author of the series in publication that are in question, [the author], is merited and, at the very least, a request to be able to contact [the author’s] head of department or person connected to their institution to gather more information on their research activities. My colleagues thought that this was unreasonably intrusive with no names or specific accusation. As a result, we have not advanced”.
As for our journal, we managed to find some email and postal addresses for the author, by searching online and going back through previous submission records. An article by the author was submitted and published in 2004, and the editor of our journal has mentioned that the paper “could easily be fabricated”. The editorial office sent a message to the author expressing concern about the integrity of a paper that was published in their journal and asked the author to respond as soon as possible. This email was sent out earlier this week, and one of the email addresses bounced, but the second one seems to have worked. We are now waiting for any sort of response.
Follow-up (September 2011):
One of the email addresses bounced, but others seemed to have got through, including one that was used by the author in a very recent paper. However, after several months we have not had any response. The author of the original email pointing out the odd pattern of author K’s publications did contact the editor of our journal having noted that the case had been brought to COPE. He had no direct link to author K, had no special insight into his work and was not from the same country as the author, but had come across the author’s publications as he was working in a similar area. For reasons to do with his own experience as a scientist, he was sensitive to possible fraud which is why he felt obliged to bring his concerns to the attention of the journal editors. The editor of our journal was convinced he was sincere.
A retired UK allergist who said he knew author K contacted us to say that he believed that the author was a genuine scientist and would not undertake scientific fraud.
We asked the reviewers of the original paper whether they had any doubts about the authenticity of the work published in our journal in 2004 and they said that they had not had any concerns. However, the paper was a case series and the information could easily have been fabricated.
The next step is for the editor in chief of our journal to contact known associate editors in the same country as the author, using the following draft text: “ Dear X, I write to you confidentially in your capacity as a trusted associate editor of xjournal. About a year ago, the xjournal editorial team were asked to look into a paper published by author K in xjournal in 2004. Many of author K’s papers are single author and contain intriguing observations, and the paper in xjournal fits this description. Although of course we have no evidence to suggest there are any irregularities, we are duty bound to look into the matter. We have tried to contact author K by email at several addresses without any success. I would much appreciate it if you would let me know if you have contact details for him or his departmental colleagues, so that we can correspond with him. This is clearly a very sensitive issue and I would appreciate your treating it as confidential”.
These associate editors may know how to take this matter to the medial association within the country. The emails are now being sent and we are waiting for a response.
Follow-up (December 2011):
In July 2011 the editor-in-chief sent an email to some associate editors of the journal in the country where we believe the author is from. We have not yet had a response from these associate editors, and we may go to the medical association of that country soon, as this case has been going on for so long. The editor had an email from the whistleblower who pointed out there had been no new publications effectively since 2009. He also pointed out that there was a legitimate Dr K and wondered if the other person was an imposter.
The process of naming and describing novel species of bacteria is governed by the Bacteriological Code. As part of this process, authors are required to deposit the type strain of the novel species in at least two culture collections located in different countries, and they are also required to provide documentary evidence that the strains have been so deposited and that the deposited strains are viable and are available to other researchers without restrictions on their use for taxonomic research. This evidence takes the form of a “certificate” issued by the culture collection. This system has been developed to ensure that type strains are available for comparison with new strains isolated in the future, and to insure against collections going out of existence and/or changes in import/export regulations, etc. The priority of names is determined by the date of publication; in our journal, which is the journal of record for the description of novel species of prokaryotes, the date of publication reflects the date of acceptance (ie, papers are published in the strict order that they are accepted). Papers are not accepted for publication before suitable certificates have been provided for the type strains of any novel species described.
A culture collection curator contacted the editor-in-chief of our journal because of concerns about three type strains that had been deposited in their collection by the same group of researchers. Investigation by editorial office staff suggested that the certificates that had been provided by the authors (which took the form of unprotected Word files) might not have been issued by the culture collection concerned. The editorial office staff then undertook an investigation of the certificates from this collection provided in conjunction with all papers submitted by this group and asked the collection to confirm: (i) the specific curator responsible for handling that strain, (ii) whether they had issued a certificate for that strain and (iii), if so, the date on which the certificate was issued. This investigation suggested that a total of six certificates provided by this group had not been issued by the collection. All six were apparently signed by the same curator (who had not in fact been responsible for handling three of the strains, hence the original suspicion).
Following the COPE guidelines for suspicions of fabricated data, as the closest match to this situation, the editor-in-chief contacted the corresponding author of these papers and asked for an explanation. It then transpired that the curator had already contacted the corresponding author to request that this group stop “misusing her signature”, as she put it. The corresponding author was extremely apologetic and assured the editor-in-chief that this would not happen again. He also indicated that one of his co-authors had been responsible for obtaining certificates for these strains but that this co-author had since left his laboratory and returned to his native country. He provided a contact address for this co-author.
The editor-in-chief contacted this co-author and he admitted that he had produced the forged certificates in an attempt to expedite publication, and thereby secure priority for the names, without the knowledge of the corresponding author or his other co-authors. Again he was extremely apologetic and assured the editor-in-chief that this would not happen again.
Because bona fide evidence has therefore not been provided that these type strains have been deposited in two culture collections in different countries, the descriptions do not fulfil the requirements of the Bacteriological Code and the editor-in-chief took the following decisions: (i) a single paper that has been published in print will be retracted and (ii) four papers that have been published ahead of print but not in print will also be retracted in print, as these papers are already listed by PubMed. A sixth paper that was still under review was withdrawn by the corresponding author at the suggestion of the editor-in-chief.
A retraction statement has been drawn up after consulting the unpublished COPE guidelines on retractions and the wording has been agreed by the corresponding author and the co-author responsible for the forged certificates. The statement indicates that a certificate was provided by the named responsible author, without the knowledge of his co-authors, that was not issued by the culture collection concerned. These retractions have not yet been published.
As yet we have not contacted any of the authors’ institutions. Our preferred course of action is to contact only the institution where the responsible author is now based. The remaining authors are based in a country where scientific misconduct is a very sensitive issue and we are concerned to avoid damage to the reputations of those co-authors who were not aware of the falsification. The editor-in-chief is also considering writing an editorial to highlight this issue and to ask other collections to take steps to prevent their certificates from being similarly manipulated. We would like the advice of the committee as to the merits of this course of action.
The Forum reiterated the fact that if something is published online then it is considered published. If the strain cannot be reproduced, then the paper is in effect fraudulent. However, there is a wider question here. Should this process be considered as purely an administration step? The advice was to make sure the instructions to authors clearly state that the authors have collective responsibility. The Forum agreed with issuing a retraction statement and naming the authors responsible but also highlighting those authors not responsible. Some members of the Forum suggested approaching the new institution where the responsible author is now based. The Forum also agreed that an editorial to highlight this issue was a good idea and also asking other collections to take steps to prevent their certificates from being similarly manipulated or to ensure tighter security.
The editor heard no more from the offending author's institution to support the rumour that his employment had been terminated. The papers concerned have been resubmitted with the legitimate documentation without the offending author's name appearing on them and they are currently under review.
One of the referees of our journal has brought to our attention a potential case of plagiarism.
The referee feels that the a manuscript submitted to our journal, representing a retrospective study of a cohort of patients with a particular condition, plagiarises an article published in another journal in 2003. The authors are from an institute in a middle-eastern country.
The submitted paper contains numerous full paragraphs identical to those in the previous paper.
We also suspect that fraud may be involved. For example, the submitted paper reports data on 28 patients (72% male and 28% female); clinical sign 1 was present in 68%; sign 2 in 26%; sign 3 in 9% and one was asymptomatic. A particular investigation was diagnostic in 45%. In the first paper, 47 infants were studied. He percentages of the parameters detailed above were identical!
We would be grateful if COPE could provide an opinion on this issue, as well as advice on what would be the best course of action.
Our editor-in-chief was considering the following course of action:
(a) Write a specific editorial on plagiarism and fraud.
(b) Publish the abstract of the published article (with the editor’s permission) together with the abstract of the submitted article with the identical text highlighted.
(c) Inform the authors of our intention and ask if they wish to make any comment.
(d) Inform the publisher of our intentions.
Does the Forum think this would be an appropriate course of action?
The Forum agreed this was blatant plagiarismbut also that fraud was likely in view of theidentical percentages in the various subgroups of cases reported. It begs the question as to whether the research was actually performed.
The advice from the Forum was to ask all of the authors for an explanation of why the text was identical to that of the other paper and why the percentages were identical. No allegation should be made and a deadline for an answer should be set. If no or no satisfactory answer is forthcoming, COPE recommends reporting the matter to the Vice Chancellor for Research at the authors’ university asking him to investigate. It was also suggested to COPE that the matter should be taken up with the Ministry of Health.
If the university does not respond appropriately, they should be politely reminded at 3 month intervals, asking for the result of their investigation.
The Forum advised that if the editor decides to publish an editorial on plagiarism/fraud etc, he should not identify the paper or authors concerned until the proper authorities have reached a conclusion.
The editor-in-chief wrote to all the authors asking each of them for an explanation as to why the text was identical to that of the other paper and why the percentages were identical. None of the authors responded by the set deadline. We have subsequently sent a reminder email and none of them has responded. We are now in the process of writing to the Deputy Director of the Research Institute where the authors performed the research, to ask him to investigate.
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.
This is how I dealt with an author who submitted a fabricated manuscript to my journal.
A junior doctor submitted a paper about the use of a drug in a particular condition. Three expert reviewers were sure that the author did not undertake the claimed study, emphasising that the drug was not available in our country (Middle Eastern country) and it had not been registered for clinical use or for use in clinical trials at the time when the paper was submitted. The author also mentioned using tests that were not available in our country at that time.
The author was advised that his paper was excellent and therefore he should publish it in a UK journal. The author took the advice. I contacted the editor of the UK journal and warned him about the author. The UK journal rejected the author’s paper.
This overseas editor was not available by telephone to discuss the case, so the Forum discussed it in his absence.
The general view of the Forum was that they could not support the conduct of the editor. The Forum wished to convey to the editor that his method of dealing with an author suspected of fabrication was not acceptable. If the editor expects authors to tell the truth, then he must set an example. The editor could have placed himself in a very difficult situation. There are clear guidelines in the flowcharts on what to do if you suspect data are fabricated and the editor is advised to follow these processes in the future. The Forum also pointed out that the editor has a role in educating the author on the seriousness of data fabrication and should have considered handling the matter himself rather than passing it on to another journal. The chair of COPE agreed to contact the editor of the UK journal to determine if the issue of data fabrication is being investigated by them.
A paper describing a novel technique was submitted. Three out of four external reviewers felt that the results could not be true. The manufacturers of the tool used in the technique provided evidence to support the reviewers’ claims that the results were not feasible.
The editor wrote to the authors asking them to explain their results. The authors replied saying that they were unable to replicate their initial results and wished to withdraw their manuscript.
The editor pressed the authors for a full explanation of the results, including the reasons for not ensuring that the results could be replicated prior to submission. The authors replied again to reassure the editor that they shared the concerns about not being able to replicate the initial results, and explaining that they had alerted their head of department who has appointed an investigation committee to look into the matter further. The authors have assured the editors that they will be informed of the outcome of the investigation.
This case has been brought to the committee for information only, as an interesting example of authors independently taking the appropriate steps to investigate anomalous results.
We had a paper submitted reporting results of a randomized trial. The trial seemed to look at immune responses in lung fluid in participants receiving either a particular vaccine or placebo. We got a copy of the trial protocol before going to peer review as per our normal editorial policy, and made sure the trial was registered.
One reviewer pointed out major discrepancies (principally in sample size and outcome measures) between the trial report, and the protocol document and registration record. We asked the authors to revise and to explain why these discrepancies had happenned. The authors explained that that the protocol and registry record originally sent were actually for a totally different study, and they had now separately registered the trial reported here. They also sent a new protocol document apparently now corresponding to the study in question.
This revised paper then went to re-review and the reviewers were happy. However in house journal staff were still worried about differences between the new protocol and the study reported in the paper. The new protocol did not seem to describe the conduct of a trial but rather a case-control study. There were also differences in the number and timing of invasive procedures being used to assess outcomes in the study, and there seemed to be more of these in the study report than in the protocol.
We went back to the authors to say we were very concerned about this and would need their explanation. If they weren't able to provide an explanation then we would alert their ethics committee.
The authors wrote back to us, cc'ing the heads of their two research ethics committees, to say that indeed, the manuscript did not match the two different protocols they sent us. They explained that there was a fault in the manuscript and not in the work carried out. They explained that the paper they sent us did not describe a single study but rather parts of 4 different approved studies taking place over the same time frame and being carried out on overlapping study populations. They then detailed aspects of these studies and explained that the different interventions, assessment of outcomes, etc, that were reported in the paper indeed corresponded to sections of approved protocols. (Although, no single protocol explained all of the aspects reported in the paper).
At this point we are very concerned about the following things:
Individual participants being recruited into many different ongoing studies - were the ethics committees aware of this and is it wise?
Selective reporting of findings. Presumably the main outcomes for the protocol describing a trial (ie the one involving randomization to vaccine or placebo) have gone unreported. Why? We are also very worried about validity of the data and analyses (even to the point of suspecting fabrication, of a sort), because of this level of selectivity.
Misrepresentation in the original manuscript. Our assumption when we see the report of a trial is that, unless it is presented as a secondary, follow up, or other type of ancillary or nested analysis, then the report describes all of the main aspects outlined in the approved protocol. This wasn't the case here, but how serious is this? Is it a form of scientific misconduct and if so who should we report it to? (The ethics committee may not care - are there any "rules" that a trial, once approved, has to be published in the form it's approved?)
At this point we are considering rejecting the paper essentially on the grounds of protocol deviations, and sending all relevant documents and correspondence to the ethics committees (who are already aware of the issues raised).
The committee warned that the ethics committees could be part of the problem, and so seeking help from them (who are already aware of the issues raised) may not be very useful. The editor provided the update that the paper has now been rejected and that the author has made a formal complaint about the editor on the grounds that the paper was mishandled. The committee were unanimous in their support for the editor who they said should remain firm in the face of the authors’ allegations. Further advice was to contact the authors’ institutions and inform them of the issues. The committee cautioned that this case highlights the need for trial registration for all studies.
The paper was rejected. The editor wrote to the chairs of both ethics committees enclosing a copy of the paper and protocol documents. The Director of Publishing dealt with the author’s complaint about the editor, and wrote back to the author to uphold the editor’s handling of the paper. We did not hear back from one of the chairs of the ethics committees but the editor did speak to the other chair, who felt that we had not understood the realities of conducting clinical research, in which protocols may change. We decided not to go to the authors’ institution to pursue this case further.
The editor received correspondence from a third party suggesting that a paper published in 2005 in the journal by four co-authors contained suspect data. The suspicion was based on the observation that in three separate figures all error bars were identical. Indeed, the third party subjected 32 publications from the same group of authors to independent statistical appraisal and concluded that 21 (66%) of the papers were suspect, in comparison with none of a large control sample of papers from other institutions publishing in the same journals (detailed confidential report supplied). Inspection of the figures did indeed indicate a consistency of error bars that were highly unlikely to have been generated by chance variation, suggesting that there is a prima facie evidence for concern about data fabrication.
Given that multiple journals appear to be implicated, what sort of coordination between editors, or within/between publishers, would offer the most effective way forward?
What should be our next action with regard: to (i) the authors of the challenged article and (ii) the third party?
Although multiple journals appear to be involved in this complicated case of suspected data fabrication, the general view was that the journal should pursue its own case in the first instance. Due process should be seen to be done and there is always the danger that waiting for a concerted effort from a number of journals could take several months or even years. Hence the advice was that the editor should write to the authors requesting the raw data, stating that it had been brought to his attention that the error bars were identical in three separate figures. This should be done without making an allegation or accusation of data fabrication but giving the authors a deadline of one month to respond. If no response is received, a second letter should be sent to the authors informing them that if no satisfactory response is received then the authors’ institutions will be contacted and informed of the situation.
Other advice offered was to have an independent statistical adviser review the paper, independently of the third party.
A number of the journals involved are published by one publisher who was represented at the meeting. The publisher agreed to encourage its editors to write to the authors requesting the raw data. However, it was agreed that it would be best to wait and see if this editor receives a response before the other editors took any action.
The Council of Science Editors (CSE) has been contacted as many of the journals are also members of the CSE. The CSE are very interested in pursuing this case through their governing body and are also eager to form some type of collaboration with COPE
The editor received a response from one of the authors in which the author stated that he had re-evaluated the results of all of the parameters and found an error in one of the figures. The raw data and covering note have been forwarded to the third party who raised the suspicion in the first instance and also to an independent statistician so that they can analyse the data and evaluate the author’s comments in the covering letter. The editor and publisher are awaiting the response from the third party and independent statistician, and will not act until such time as they have received this information.
The publisher in the meantime is also pursuing the matter.
Further update (August 2007) The editor has received a response from the third party and the independent statistician and is in the process of reviewing the information.
I became involved in this issue after reports from doctors in a developing country that three papers in a systematic review published by my company may have been fabricated.
The papers in question had co-authors in two other countries and so I contacted them.
One co-author replied that he had concerns, but as none of the studies was conducted in his country, he had no data. He said he was unaware of the papers until Dr X told him they had been accepted in the journals.
Another co-author was unaware of when or where the studies took place. He said that Dr X had been suffering from depression for several years and had committed suicide. He had been included as a co-author on his last three articles more out of friendship than any active scientific cooperation.
A third co-author explained that his role was “philosophical” rather than clinical. To his knowledge the study was conducted personally by Dr X, probably in his own country, and he only helped him with discussions and text revisions.
Because several of Dr X’s papers were published by Journal A, I wrote to the editor of Journal A to see if he had any concerns. He replied that he had doubts about the validity of the data, which were raised in an editorial by Dr Z. I am waiting to hear if the editor of Journal A is willing to help investigate the papers. I also contacted Dr Z and raised the possibility of fraud with him. He said that he had “serious concerns about the work” but declined to help me investigate.
We have withdrawn the review until we can find out if the data are real. I have written to the National Committee on Ethics in Research in the author’s country but have had no reply. An international expert on the statistical detection of fraud is currently looking at the papers. He has some concerns but his investigation is ongoing.
Dr X was a prolific researcher with about 16 of his own first authored papers cited in his clinical trial reports. It appears that many doctors suspect misconduct but none has been prepared to voice their concerns or to take any action.
I would greatly appreciate COPE’s advice.
This complicated case provoked much discussion. The advice was to reinstate the review but without the three disputed papers, adding a note to say that there is a potential problem with these three papers. It was felt that if the data are fabricated, there was a responsibility on the part of the editor not to publish the data as there might be a significant risk to patients if the trial was repeated.
As there has been no useful response from the other journal editors who published other papers by this author, it seems there is no point in pursuing this line of enquiry. However, the editorial procedures in these journals must be criticised as the editors strongly suspected that the data were fabricated but still went ahead and published the papers. COPE could take some action if they were members, but they are not.
The committee agreed that the best approach for the editor would be to seek a retraction of the papers from the co-authors on the basis of gift authorship. The advice was to write to the co-authors, ask for the data, and if not provided, ask them to withdraw the papers. In this way, it is not necessary to say that the data are fraudulent, with all its legal implications. It was felt that the co-authors must take responsibility for the data as their names are on the paper. It is not acceptable to say that their contribution was merely “philosophical”. Gift authorship is not acceptable. Also, the co-authors’ institutions should be contacted and informed of the situation. In this instance, the editor should write to the co-authors informing them that he has contacted their institutions.
Following COPE’s advice, the living co-authors were contacted to see if they would retracted the reports in question on the basis that they were gift authors and could not take responsibility for the results. However, when this was raised with them they did not agree that they were gift authors and declined to seek retraction, arguing that the papers were published in an international peer reviewed journal, that the first author had taken responsibility for their content and that they knew the first author well and believed that “he would never have been able to do something false.” They persist in this view despite the fact that the stated deceased lead author’s affiliation has been contacted and they confirmed that the lead author was never employed by the university. It seems that the co-authors want it all ways—they claim that they are not gift authors but yet they refuse to take any responsibility for the content, even in the presence of evidence that the lead author gave incorrect information about his affiliation. The matter is ongoing.
Further update This case has been the subject of an article and an editorial in the BMJ. The articles outline the details of the case and consider the wider implications of the case, a summary of which is given here:
We are left with serious doubt about important studies but with no way of determining with confidence whether the results are fabricated or real. The main author is dead. There is no institution to investigate. The implications for patients are serious. They are being treated on the basis of potentially unreliable evidence. It is plausible that this drug in high doses may worsen rather than alleviate the condition. Shortly after the withdrawal of the review, the journal was contacted by US researchers preparing guidelines for the management of this condition and by a UK group asking about the outcome of our investigation because the authors’ results were about to be incorporated into guidelines.
If it wants to retain the confidence of the public and politicians, the scientific community needs to do better. Only a minority of countries have an effective national system for responding to scientific misconduct. However, research is a global enterprise and a strong case exists for an international body to respond to the problem of research misconduct.