“Exactly the same clinical study” published six times

A group of researchers conducted a clinical trial on hundreds of hypertensive patients. Then, they published the results…six times.

The “nearly identical” papers came to our attention via a retraction in Inflammation. Editor in chief Bruce Cronstein explained how he learned of the mass duplication:

The editors were contacted en masse by somebody doing a Cochrane Review on hypertension and who noticed that the content of the 6 papers was nearly identical.  Frankly, not one of us would have noticed otherwise.

Another of those papers, in the European Journal of Pharmaceutical Sciences, has also been retracted. That note is similar to the retraction notice for the Inflammation paper, both of which have been cited twice:

This article has been retracted at the request of the Editor-in-Chief.

The authors have published results from exactly the same clinical study and patient population in 6 separate articles, without referencing 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. 2013. Olmesartan/amlodipine combination versus olmesartan or amlodipine monotherapies on blood pressure and insulin resistance in a sample of hypertensive patients. Clinical and Experimental Hypertension 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. 2013. 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 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. 2013. 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 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. 2013. Evaluation of safety and efficacy of a fixed olmesartan/amlodipine combination therapy compared to single monotherapies. Expert Opinion on Drug Safety 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. 2014. Different aspects of sartan + calcium antagonist association compared to the single therapy on inflammation and metabolic parameters in hypertensive patients. Inflammation 37: 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. 2014. 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 51: 26–33. doi:10.​1016/​j.​ejps.​2013.​08.​031.

In addition, the article in Inflammation contains results published especially in articles 2 and 6, which is the main reason for retraction of the article in Inflammation.

The publisher apologizes for the inconvenience caused.

Cronstein, the Inflammation EIC, elaborated to us about the extent of the overlapping data:

Basically a lot of the data that was identical from one paper to the next was demographics and descriptive numbers about the patients. Some of these numbers were derived and reported more prominently as data in other papers (graphs vs listing in tables). In others more detailed results were given in one article but not another.

He also told us how the corresponding author reacted:

The response of the corresponding author of these papers was both aggressive and legalistic. In the first response there was a description taken from COPE of “salami” publishing vs multiple publishing. In the second response we, as editors, were told that we were in fact remiss for not catching this when it first happened.  Obviously, since these were all submitted around the same time and the author letter assured us that this work had not been submitted elsewhere none of us could have known this. The retractions of the remaining papers is in the works. All of the editors of the journals involved had multiple email rounds and a conference call to discuss our responses. In addition to the editors there is a council or committee for the parent publications of most of the publications which must agree to the retraction.

He told us about his next step:

Finally, I would like to notify the appropriate Dean, etc at the corresponding author’s institution. In the US, such scientific misconduct (which is what this is) would be reported to our Dean and a specified process would begin (assembly of a faculty committee) that would determine whether the individual has committed misconduct and make suggestions as to appropriate redress. I am not sure what will happen when this is reported to the responsible authorities at the author’s institution.  I am also waiting to hear from the other editors as to how they would like to proceed on this issue.

We contacted Giuseppe Derosa, a researcher at the University of Pavia in Italy, who is the first and corresponding author on all the papers.

We also contacted the other affected journals — Expert Opinion on Drug Safety,  Journal of the American Society of Hypertension, the EIC of Journal of Clinical Pharmacy and Therapeutics, and  Clinical and Experimental Hypertension.

We’ll update if we hear back.

Hat tip: Rolf Degen

Like Retraction Watch? Consider supporting our growth. You can also follow us on Twitter, like us on Facebook, add us to your RSS reader, and sign up on our homepage for an email every time there’s a new post. Click here to review our Comments Policy.