Retraction Watch

Tracking retractions as a window into the scientific process

Authors defend publishing clinical trial six times, even as they earn two more retractions

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Screen Shot 2015-09-30 at 12.14.06 PMIn August, we reported on a clinical trial on hundreds of hypertensive patients that was published six times. Now, copies published in Expert Opinion on Drug Safety and Journal of the American Society of Hypertension (JASH) have been retracted, making for a total of three retractions for the group of papers.

The authors have defended the papers as being decidedly “different,” but one of the latest retraction notes points to an earlier retraction by some of the same authors (including first author Giuseppe Derosa, at the University of Pavia in Italy) for publishing two papers that “contain considerable text that is duplicative.”

Inflammation editor in chief Bruce Cronstein, who retracted one of the six duplicated papers from the clinical trial, told us in August that he and the editors of the other journals were all contacted “en masse” by an author doing a Cochrane Review on hypertension, who noticed that all six papers were “nearly identical.”

Just recently, we received a statement from the authors — sent by corresponding author Derosa — which argued that even if six papers stem from one trial, each was decidedly “different:”

[W]e had a lot of data to manage. Even if all the papers originate from the same clinical trial (for this reason patients characteristics and treatments administered were the same), different aspects were considered in every article, we considered different endpoints and different parameters involved.

The statement — here’s the PDF — further defends their choice to submit several publications:

At first, we considered to publish an unique article analyzing all the aspects of the trial together, but it was impossible for two reasons:

  •  Most of the Journals ask to not exceed in the number of words of a submitted paper in order to gain space to publish more articles on the same issue of the Journal and increase Journal citations. Considering the complexity of our study, and the number of parameters, linked to very different aspects of hypertension, endothelial damage, and inflammation, condense all in one article was not possible.
  • Moreover, as you can easily understand, the cost of the laboratory kits necessary to dose various parameters were very high and we could not afford all the costs together. So, we decided to freeze patients samples for a limited period of time, and to divide the various parameters according to the different endpoints, and to dose parameters in different periods of time according to funds availability.

They also argue that they didn’t try to cover up anything:

Our good faith can be witnessed by the fact that we did not try to change Authors order or Authors names. Moreover, we did not try to hide the fact that the study population was the same, we did not change the number of patients or patients characteristics.

The author statement says that, according to guidelines from the Committee on Publication Ethics (COPE),

…this can be considered a MINOR overlap case, defined as ’salami publishing with some element of redundancy”.

In August, Inflammation EIC Cronstein told us that he initially thought it was indeed a case of “salami slicing,” “but on review there were large chunks of data that were reported multiple times.”

The notes for the new retractions are very similar. Here’s the one from Expert Opinion in full (click here to read the note from JASH):

The Editor and Publisher regret to announce the following article published in 2013 has been retracted from publication in Expert Opinion on Drug Safety.

The authors have been found to have published overlapping results from exactly the same clinical study and patient population in 6 separate papers, one being the above referenced paper from Expert Opinion on Drug Safety, without referencing any of the publications in any of the later articles:

1. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’angelo, A., Maffioli, P. Olmesartan/amlodipine combination versus olmesartan or amlodipine monotherapies on blood pressure and insulin resistance in a sample of hypertensive patients. Clinical and Experimental Hypertension 2013 (35) 301-307 DOI: 10.3109/10641963.2012.721841

2. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’Angelo, A., Maffioli, P. Effects of an olmesartan/ amlodipine fixed dose on blood pressure control, some adipocytokines and interleukins levels compared with olmesartan or amlodipine monotherapies. Journal of Clinical Pharmacy and Therapeutics 2013 (38) 48-55 DOI: 10.1111/jcpt.12021

3. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’Angelo, A., Maffioli, P. Variation of some inflammatory markers in hypertensive patients after 1 year of olmesartan/amlodipine single-pill combination compared with olmesartan or amlodipine monotherapies. Journal of the American Society of Hypertension 2013 (7) 32-39 DOI: 10.1016/j.jash.2012.11.006

4. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’Angelo, A., Maffioli, P. Evaluation of safety and efficacy of a fixed olmesartan/amlodipine combination therapy compared to single monotherapies. Expert Opinion on Drug Safety 2013 (12) 621-629 DOI: 10.1517/14740338.2013.816674

5. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’Angelo, A., Maffioli, P. Different aspects of sartan + calcium antagonist association compared to the single therapy on inflammation and metabolic parameters in hypertensive patients Inflammation 37 (2014) 154-162 DOI: 10.1007/s10753-013-9724-x

6. Derosa, G., Cicero, A.F.G., Carbone, A., Querci, F., Fogari, E., D’Angelo, A., Maffioli, P. Results from a 12 months, randomized, clinical trial comparing an olmesartan/amlodipine single pill combination to olmesartan and amlodipine monotherapies on blood pressure and inflammation. European Journal of Pharmaceutical Sciences, 2014 (51) 26-33 DOI: 10.1016/j.ejps.2013.08.031

Expert Opinion on Drug Safety published this article in good faith, and on the basis of signed statements made by the corresponding author regarding the originality of their work. The article is withdrawn from all print and electronic editions.

The JASH note points to another retraction by the journal for “Enalapril/lercanidipine combination on markers of cardiovascular risk: a randomized study,” also the result of duplication:

Dr. Derosa published ostensibly similar papers in the Journal of the American Society of Hypertension and another journal. These two articles were both submitted for review on the same day and contain considerable text that is duplicative:

1. Derosa G., et al. Enalapril/lercanidipine combination on markers of cardiovascular risk: a randomized study. Journal of the American Society of Hypertension 2014;8:422-8.

2. Derosa G., et al. Effects of enalapril/lercanidipine combination on some emerging biomarkers in cardiovascular risk stratification in hypertensive patients. Journal of Clinical Pharmacy and Therapeutics 2014;39(3):277-85.

When we discovered this additional retraction for duplication, we asked Derosa if he had an additional statement; he said the previously submitted statement from the authors applies to both sets of retractions.

The Expert Opinion paper has not been cited, and the JASH paper has been cited four times, according to Thomson Scientific’s Web of Knowledge. We emailed the EICs of Expert Opinion and of JASH to see if they had anything else to add to the notes. Derosa noted he does not agree to the retractions.

As to the remaining papers on the list of six from the same trial, the first two papers have not yet been retracted; the first appears to have been published first, online in September 2012. We’ve contacted the journal Clinical and Experimental Hypertension to see if they have any plans to retract the paper.  We also emailed Alain Li Wan Po, the EIC of Journal of Clinical Pharmacy and Therapeuticsand asked if there was a retraction forthcoming of the paper in his journal. He said:

Yes the retraction is underway

Hat tip: Rolf Degen 

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Comments
  • AMC October 14, 2015 at 11:35 am

    If this was truly salami slicing then why didn’t the authors cite the papers the repeated data was originally published in? I can understand reusing information in order to tell a complete story but not citing previously published data seems shady to me.

    Note: I only checked the latest paper and none of the earlier ones were cited.

  • Paul A. Thompson October 14, 2015 at 3:35 pm

    There is no problem, IMHO, with publishing different parts of a study in different papers. The key, as noted by AMC above, is that the canonical design paper should be cited, there should be one paper designated as publishing the key results, and other papers should cite all previous papers. It is not enough to note that the simultaneous publication made referencing difficult. The obvious solution is to delay publishing secondary outcome results until primary outcome results are in the record.

  • Fakhreddin Jamali January 20, 2016 at 2:32 pm

    After a thorough investigation, our editorial team has decided to retract an article published by Giuseppe Derosa,Pamela Maffioli, Ilaria Ferrari, Ilaria Palumbo, Sabrina Randazzo, Angela D’Angelo, Arrigo and FG Cicero (J Pharm Pharm Sci 13(3) 378 – 390, 2010). We retracted the article as the data, with minor differences, were later published elsewhere (Derosa et al J Clin Pharm Ther 36:592-602, 2011). Our action followed many other retraction of articles by these authors (read http://retractionwatch.com/category/by-subject/clinical-study-retractions/cardiology-retractions/page/2/). It is alarming that, in defending their action, the principal author (G. Derosa) sees nothing wrong with this serious breach of publication ethics.

    Fakhreddin Jamali, Editor-in Chief,
    Journal of Pharmacy and Pharmaceutical Sciences

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