In 2013, our journal published a paper describing an observational study comparing two drugs (A and B) for the management of a chronic disease over a period of 10 years. The conclusion in the paper was that mortality was higher in group A (97 deaths) compared with the other group B (52 deaths) (hazard ratio 1.76, 1.22 to 2.53; P=0.003). This analysis was done after adjustment for a large number of confounders, and was approved by our statistical advisor. The authors of the papers did acknowledge that this was an observational study, and did state that residual confounding might be present.
In 2014 we received a letter of concern by a researcher, employed by the company selling drug A, who felt that the authors of the 2013 paper omitted essential information that might impact on the conclusions. It appears that the routine management of this disease has changed substantially over the 10 year period, and this should have been treated as a confounder for which statistical adjustments should have been made. This change in routine management of the disease is documented in a paper published in 2014, but the researcher felt that these authors were probably aware of this much earlier and should have disclosed this information during the review process of their 2013 paper.
In our initial response in July 2014 to the letter of concern, we asked the researcher who sent us the letter of concern to send us a detailed rapid response to the 2013 paper, which we could publish. We have also asked advice of our statistical advisor who reviewed the 2013 paper, and he acknowledged that this information might impact on the statistical calculations and thus the conclusions of the paper. But with the data available to him, he is not able to make a definitive assessment of how much impact it would have. He has suggested to put these questions to the authors of the 2013 paper.
Question(s) for the COPE Forum
The researcher who raised the concern has not made his concerns public by sending us a rapid response that we could put to the authors and publish, with their response, on our website. We will certainly put the questions to the authors of the 2013 paper, but we wonder if we should publish these concerns?
Another problem is that, due to the complexity of the statistical calculations, we are entirely dependent on the authors to judge whether the routine management data would have seriously impacted the conclusions of the 2013 paper.
The Forum agreed with the course of action of the editor to date—namely, inviting the researcher to write a formal note, stating his concerns, that can be made public and the authors can then be invited to make a response. This ensures the process is transparent. But if the researcher who raised the concern does not want to make his concerns public, there may be little that the editor can do.
One suggestion was that the editor could publish the concerns anonymously and invite the authors to respond. Another suggestion was to treat this as you would a whistleblower by investigating the issue, and asking the authors to respond specifically to the questions raised by the researcher if necessary. It is clear that the editor has concerns about the paper and these should be addressed in some way.
So, the best option may be for the journal to publish the concerns, not necessarily revealing the researcher’s identity, and invite the authors to respond.
The researchers who sent a letter of concern sent a letter to the editor which was published, and which was answered by the authors of the original paper.
The journal’s statistical advisor has found the response satisfactory. The editor considers the case now closed.
Our journal (journal A) received a complaint from a 'Clare Francis' alerting us to a case of duplicate publication involving our journal and another (journal B). The article in journal A was published first, but submitted after the article in journal B. Clare Francis requested that the article in journal A should be withdrawn as it is duplicate publication. However, the article in journal B was an extended abstract, included in a section of selected conference proceedings. Our records do not go back far enough to check whether the authors informed us of this but they did not reference their abstract in the article in journal A. The article in journal A is a full paper, with a materials and methods section, detailed results and enough information for someone else to replicate the experiment. The extended abstract in B was not. When we contacted the editor of journal B, we were informed that they had received several such complaints from Clare Francis which have turned out to be somewhat spurious.
A simple Google search revealed that 'Clare Francis' is a widely known self-styled whistleblower in scientific publication.
We responded that we had looked in detail at both papers and did not consider it to be a case of duplicate publication, and that we considered the matter closed. Clare Francis did not agree, and reiterated the issue of the article submission timings, insisting that the paper be withdrawn, and seeming to ignore the substance of what had actually been published. 'She' appealed to our status as a member of COPE as a reason that we should take on board these concerns. We believe not only that using a pseudonym to pursue these matters is unethical, but that we have followed the correct procedure and have made the correct decision regarding these papers. We would be interested in hearing if the Forum agrees (on the former points, if not the latter).
The Forum agreed with the editor that it would not consider prior publication of an extended abstract as duplicate publication, unless the extended abstract was very detailed and included lots of data, which was not the case in this instance. The editor made the right decision. COPE supports a whistleblower’s right to remain anonymous and would encourage editors to respond to any allegations of unethical behaviour as long as there is specific evidence and not just vague accusations.
We replied to Clare Francis saying we had been to COPE and were satisfied that we had done the right thing, and we are not going to change our course of action. She responded along much the same lines as the original complaint—we did not respond and consider the matter closed.
In a recent and very prominent case of publication misconduct resulting in the retraction of 12 research papers (to date), many journals have been included in ‘round-mails’ from the whistleblower and other scientists. Our journal (a reviews and features journal) has published a review from the main author associated with the misconduct, which contains reference to six of the retracted papers.
As editor, I have been urged a number of times via email (the true sender of which was not always clear) to retract the said review. At first—before the full extent of the retractions was confirmed—I could do no more than wait, rather than react prematurely, although even at that stage, tracking and trying to verify the claims took some time. Now I have analysed the review—which took a significant chunk of time—and identified the parts that cite the six references. Those constitute around 18% of the body text, mainly the more novel insights.
Qualitatively—and that is clearly more important than quantity—it is exceedingly hard to judge whether the retraction of the six articles nullifies those conclusions and insights. I should furthermore assume that the rest of the review is in order unless (till) proven otherwise. In fairness, I think that if any corrective measure is to be taken, it amounts to a corrigendum noting that the said references have been retracted.
However, I am concerned about the additional workload that investigating the impact of retractions could have if we generally adopt the procedure of publishing corrigenda for every article that they affect. An alternative way of looking at the problem is to acknowledge that retracted references are registered as ‘retracted’ in the scientific indexes (although only if the journal concerned is indexed), and in the venues of publication, and hence on tracing a reference to its source, the reader of the review in which it is cited will see that the particular section of text is no longer supported by a published article.
I am in a quandary between providing the most up to date information in immediate connection with an article and getting into something that could consume significant amounts of already very stretched editorial resources, and then, more importantly, require further corrigenda on the same article if more references are found to be faulty at some point in the future: a seemingly never-ending story...
What is COPE’s advice?
The Forum agreed that the main priority is to inform the journal’s readers of the situation. The advice was to issue an expression of concern, stating the facts, that around 18% of the review text relates to retracted papers. It is then up to readers to evaluate the review and draw their own conclusions. The Forum questioned if the editor believed the article is tainted because the author has already been associated with misconduct. Some suggested contacting the author and asking him if he would like to retract the paper, or contacting the institution for a ruling.
Another suggestion was that the editor could write an editorial discussing the issue and whether removal of the six references alters the conclusions of the paper.
All agreed that the main issue was to alert the readers by way of an expression of concern rather than a correction.
The editor decided to publish an expression of concern which listed the papers referenced in the review article that had since been retracted by the respective journals.
The editor in chief received a letter to the editor criticising a paper published earlier in the journal. The editor first told the author of the letter that he would publish the commentary after he had given the authors of the criticised paper a chance to respond. When asked by the author of the letter, he later added that he would also publish the letter if the authors failed to respond.
The corresponding author of the paper explained that the same person had attacked every single article from his group for about 5 years, that they had responded to the critics adequately in the past and declined doing so again in this instance. He portrayed the letter as a disingenuous and fraudulent commentary and asked that we do not publish the letter, which in his view would be a disservice to science.
He attached to his email a correspondence with the editor of another journal, detailing a similar case for one of his previous articles. He also copied in four editors of other journals who received similar commentaries from the same person, as well as one opinion leader in the field. The four editors had rejected the letters and two had banned the author of the letters from publishing in their journal. One of these editors replied to confirm the story, stating that in his view, the letter he had received was not founded on fact, and backed the request not to publish this new commentary.
At this stage, the editor of our journal contacted me as managing editor to ask if he could reject the letter outright. I advised that he could, but only based on the scientific merit of the letter, and not on the history of its author. He sent the letter for review to the associate editor who handled the criticised paper, and who briefly concluded that the commentary was probably not worth publishing. The editor then rejected the letter, initially mentioning various peer reviewers, when in fact there was only one short set of comments.
The author of the letter was quite irate as, based on the editor’s initial replies, he expected his letter to be published in any case (with or without a response from the authors) and found the peer review process and decision letter that he received unsatisfactory. A first clarification of our position resulted in a long threatening point-by-point response, to which the editor responded by reasserting his position and clarifying again why the letter had been reviewed by a referee and himself and subsequently rejected.
The author of the letter then changed tactics and sent the publisher a rather libellous letter in which he argued that the editor is incompetent, was not impartial and was influenced by the author of the article; that the author of the paper and the peer reviewer (whose identity he does not know) have undisclosed conflicts of interest; and that opposite interests and prevalent opinions, relayed by a mainstream advocacy group and the WHO, colluded to silence him, a whistleblower. One of the assumed conflicts of interest mentioned involve the head of an institution from which the authors received a grant and is therefore very indirect. Another, however, relates to a global advocacy group, endorsed by the WHO and which seems to reflect the predominant opinion in the field, and which the authors presumably belong to. The corresponding author of the paper calls this group a forum for exchange on the topic, but it has a clear health policy agenda. The authors did not mention this in their declaration of interest.
Our publisher informed him that she was taking his concerns seriously and would ask me to investigate in accordance with COPE’s guidelines, particularly in relation to our disclosure policy. Although the author of the letter accused us of being in breach of the COPE policy on fair peer review in an earlier correspondence, he then replied that in this case COPE’s ‘concepts’ are meaningless and, for example, anonymous peer review or impartiality are impossible, since he is the only researcher “who has exposed a long series of frauds” on the topic. He went on to reiterate his request that we (a) do not contact the authors of the paper he criticised (he was initially fine with the authors responding to his critique), (b) ask referees specifically if they belong to the advocacy group discussed above and (c) send, if needed, his blinded manuscript to ‘independent’ (from the advocacy group mentioned and industries) reviewers, of which he proposes three names.
We have not replied to this last email and decided to seek COPE’s advice on how to best close the case and what we should have done better earlier. In particular, I'd be interested in your opinion on: — how the editor should have communicated with the author of the letter in the first place? What are the main weaknesses in our handling of the case? — if the authors of the criticised paper belong to an advocacy group, should they disclose this in their declaration of interest section? — how to respond to the author of the letter about allegations of unfair peer review, and his rejection of a blinded peer review system? — should we, and how could we, check whether the author of the letter is genuinely trying to make valid points against prevalent opinion? — on the other hand, should he have an undisclosed agenda, should we take any action against him?
His letters and emails are often unconvincing, based on assumptions, defamatory and threatening, and he seems to belong to an opposite advocacy groups without disclosing it. In addition, the bulk of his contributions to the literature is made of commentaries criticising articles but he does not appear to publish any original research himself.
The COPE Code of Conduct states that editors must be willing to consider cogent criticisms of work published in their journal. However, the editor needs to decide if this is “cogent criticism” or not. The Forum suggested there were three issues here: (1) whether the editor should publish the letter; (2) the undisclosed conflict of interest of the authors; and (3) the defamation of the editor on websites.
Regarding whether the editor should publish the letter, the Forum noted that editors have a duty to publish letters unless they are factually incorrect or libellous, and it is the responsibility of the editor to make that decision. Some of the members of the Forum argued that an editor should veer towards publishing everything, while others noted that there are different types of letters in different journals and it is not always appropriate to publish. However, all agreed that the editor should not make false claims (saying that the letter would be published with or without a response from the authors and then going back on that decision) and that the journal needs to tighten its editorial processes. The journal should have a clear process for handling letters. Are they peer-reviewed? The decision to publish a letter should be based solely on its academic merit.
Regarding the undisclosed conflict of interest of the authors, the editor should contact the authors directly and ask them to respond to this accusation and emphasise that non-financial conflicts of interest are also very important. If it transpires that the authors do have a conflict of interest, the editor could publish a correction. The editor should also check the journal’s policy on this issue.
On the third point, if an editor is defamed on a blog or website, what can he do? Some suggested a dignified silence as the best option as otherwise it can fuel the problem and encourage more debate. However, all agreed that if the accusations are potentially libellous then the editor should seek legal advice.
I contacted Dr C, the author of the letter, to let him know that his case had been discussed at the COPE Forum and to reiterate our decision not to publish his letter. Most members present, if not all, supported the view that the editor in chief can reject a letter or commentary at his discretion. I sent a brief overview of the discussion and explained that the COPE Forum was of the opinion that declarations of interest should relate only to direct potential conflicts of interest. That meant that the disclosure in the criticised paper was satisfactory and appropriate.
The remaining question concerned the author’s role within an ‘advocacy group’.
I said we would contact the author and ask him to clarify the purpose of the group, their involvement in it and whether they think it might be a conflict of interest. We would then assess their response against our current requirements regarding declarations of interest.
Dr C quickly sent a couple of inflammatory emails in his usual style, where he repeated that there is a “universal conflict of interest that must be disclosed” because 90% of authors, editors and reviewers belong to the same bias ‘advocacy group.’ He then went on to contradict himself and, in my view, invalidate his only claim which may have had some merit:
“I would like to clarify that [the group] is absolutely not an ‘advocacy/regulatory group’. To take a modern example, it is something like Facebook where authors [...] advertise and publish the kind of publication that I have criticised in details for their flaws. In that case I don’t really see what the problem is.”
I intended to get the author’s opinion on this but have not pursued the matter.
I’ve not heard anything more from Dr C since and consider the case closed.
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.
(1) An article was published after peer review. Shortly after online publication we received a message from a reader (an academic who works in the same field as the authors) notifying us of a major concern with one of the figures in the article.
“I am writing with regard of manuscript XXX recently published in XXX. These studies raise significant expectations in XXX patients, because the proposed strategy achieved unanticipated therapeutic success in a preclinical model of XXX.
I am writing because I’ve noticed a major problem in Figure X. It appears that two of the panels (X and X), which are supposed to be representative of two different XX specimens from two different experimental groups, belong to the same tissue section (or quasi-identical serial sections)....However, the major problem in this figure is that the two panels are only partially identical. ...These observations raise the concern that the pictures have been intentionally manipulated, and I believe that this concern should be brought to your attention.”
(2) We contacted the authors without revealing the concerned reader's identity and without implying any judgment as follows:
One of our readers has noticed a potential problem with one of the figures in your paper (see below) and I'd like to get your input before deciding how to respond.
“I am writing with regard of manuscript XXX recently published in XXX. These studies raise significant expectations in XXX patients, because the proposed strategy achieved unanticipated therapeutic success in a preclinical model of XXX.
I am writing because I’ve noticed a major problem in Figure X. It appears that two of the panels (X and X), which are supposed to be representative of two different XX specimens from two different experimental groups, belong to the same tissue section (or quasi-identical serial sections)....However, the major problem in this figure is that the two panels are only partially identical.”
(3) The authors responded initially by sending higher resolution images saying:
Please find the attached fig. X. At original magnification it is obvious that the problematic 2 panels are taken from different samples. We are happy to send the original pictures.
(4) We asked one of our editorial board members who has relevant expertise in the area of science and in digital imaging to look at the higher resolution images, in confidence. He responded with the following:
“If the claim is that the three photos of Fig. X represent different samples I would in indeed have a problem with that. Same elements look identical. Difficult to prove though as there are larger parts that differ. Nevertheless, that concerned reader may have a point. I am suspicious, too, that the figures have been manipulated.”
(5) We went back to the authors asking for the original digital images with the following message:
I had forwarded your high resolution version of figure X to the person who originally expressed concerns and received a message in which the person states that his/her concerns remain. I then sent the high resolution image to one of our regular advisers who has experience in neuropathology and digital images. This person agrees that parts of the lower two panels of Figure XB look very similar and that we should ask to see the originals for all three panels in Figure X and obtain detailed information about which software was used and whether the images were digitally manipulated in any way.
As a consequence, I am now asking you to send the original images and any relevant information you have.
(6) They responded by sending three images and the following:
Please find the attached requested original images. Adobe Photoshop was used to reduce brightness, increase contrast and compress the images to JPEG format. The JPEG images were inserted into Powerpoint file where borders of the tumours were marked. No additional manipulations were made to the original images. Please let me know if you need any additional information.
(7) We asked our production people to look at the originals and they felt that there was no better evidence that the images came from different samples. I went back to the authors one more time to give them a chance to tell us more:
“I have now shown the images to several people who know more about digital image generation and processing than I do. All of them find that the striking similarities between groups of cells in the middle and low panels make it hard to believe that the two images come from different tumors (as is implied in the figure legend and your earlier messages).
As it doesn't seem that we are able to resolve the issue easily, we will need to conduct a more formal investigation (most likely with the help of people outside of PLoS). If there is any additional information you can provide, please do so by XXX.
I regret the inconvenience this is causing for all of us, but we feel that we must take the issue seriously.”
(8) To this the authors responded:
“I find this conclusion rather odd and not in accordance to our laboratory protocols. I can assure you that we shall cooperate in any way you see fit and our records on the study are open.”
and, in a separate message a few hours later:
“I am looking again at these pictures. If you carefully study the images you will find that almost all the fields are different and there is no similarity at all. You always can find groups of cells, with a bit of imagination you can make them look similar. I can assure you that all this study is fully controlled and the reproducibility is excellent. We now have even results with the systemic application of the XXX vector to disseminated tumors. I find it hard to believe that I am going to be under investigation questioning my scientific integrity.”
(9) We then enlisted the confidential help of an editor from a different journal who is an expert on manipulation of digital images and has software that can look for specific alterations. We have not heard back from him yet.
What do we do if he (the editor from a different journal) tells us that he has detected manipulation beyond what the authors said they did?
What do we do if he says there is no evidence of manipulation of these images?
What do we do if he says he cannot confirm either way?
More generally, have we handled this process appropriately thus far?
It was agreed that the handling of the matter to date had been exemplary in the editor’s careful and considered approach. With all parties, except for the authors, feeling that some sort of manipulation had taken place with the figure, the only remaining course of action was for the editor to write to the author’s institution and raise the concerns with them.
The author’s institution was contacted and the editor forwarded all relevant correspondence with the author and, in anonymised fashion, correspondence with the scientists who brought this to their attention. The rector of the author's university has assured the editor that they take this seriously, have asked that the journal take no further action while they are investigating and will inform the journal of the outcome.
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 letter was sent to an editor, claiming that scientific misconduct had taken place in Russia. The editor did not want to ignore the issue, which was not related to submitted papers and could not be published as a letter. But s/he was unsure what action to take.
This would be best pursued as an investigative news story.