A distorted record on blood pressure drugs: Why one group is trying to clean up the literature

In 2015, a group of researchers based in Spain decided to write a review article on high blood pressure. But when they looked over eight articles co-authored by the same person, they noticed some undeniable similarities.

Over the last few years, Giuseppe Derosa, based at the University of Pavia in Italy, has racked up 10 retractions after journals determined he’d published the same material multiple times. But there’s much more to this story: The researchers in Spain (led by Luis Carlos Saiz of the Navarre Regional Health Service in Pamplona) kept digging into his publication record, and have since identified dozens of additional potential duplicates. Although the outside researchers alerted journals to the additional potentially problematic papers in 2015, most have not taken action; recently, two journals published by Taylor & Francis flagged 12 of Derosa’s articles, three of which they had been alerted about in 2015 by Saiz and colleagues.

Now, Saiz is telling his story — and why duplication of medical research matters:

All misleading scientific literature can have a potential impact on patient care. When evidence is distorted in some way, future clinical decisions can be easily affected.

In a recent article in BMJ Evidence-Based Medicine, Saiz and his colleagues describe their quest to uncover the scope of Derosa’s alleged duplication. After discovering the eight similar papers, the researchers first contacted Derosa. Saiz told Retraction Watch:

We asked him for more information on his articles, to decide whether they might be included in our review or not and to confirm that they were different studies. He only replied briefly that they were different. Then we asked him if we could have access to the eight protocols to prove they were really different studies. Due to a lack of response from his side we contacted the editors.

Over the next two to nine months, responses from editors trickled in — “a reasonable time,” Saiz and his colleagues write. The two earliest papers related to two different trials were saved, and the other six retracted.

Saiz and his team didn’t stop there, he told us:

…we decided to investigate proactively in order to know if such findings were just isolated cases and, more interestingly, to follow up in-depth how the editors and publishers react to this kind of situations.

In September 2015, Saiz and his team searched for other randomized clinical trials by Derosa, identifying 121 (minus the eight they’d already flagged), of which 78 listed Derosa as the principal investigator. They asked three independent reviewers to look over each paper, and only deemed it redundant if all three agreed. In the article, they write:

Of the 78 papers identified, 39 (50%) were suspicious of redundancy. More specifically, the trials published in the 2004–2014 period were centred on comparing antidiabetic treatments and antiobesity drugs. We identified 39 papers related to 15 different RCTs (nine duplicates, three triplicates and three quadruplicates). This conclusion was based on the observation that different papers provided a large amount of identical data. In addition, the authors tried to mask redundancy by changing titles, tables  and figures, and also avoided citing previous published articles on the same study. In the rare cases where they did cite previous articles, there was no mention to the fact both articles were based on the same study.

The papers were published in 22 journals from 10 publishers; in October 2015, Saiz and his team reached out to the editors of each journal. Eighteen responded within a month; the remaining four got back to them within six months.

But after that, the response was uneven, said Saiz:

Some of them reacted as expected, according to a reasonable range of time and providing well-founded decisions. Unfortunately, many other journals/publishers have not reacted as they likely should, delaying decisions while providing us with scarce information on the process…In some cases no particular action has been judged needed by editors, which also disappointed us in the light of the evidence.

Among the 39 additional potential duplicates, only four have been retracted more than two years later.

All misleading scientific literature can have a potential impact on patient care”

One publisher who has taken action is Taylor & Francis. Recently, the publisher issued expressions of concern about 12 of Derosa’s papers, split over two editorial notices in Expert Opinion on Pharmacotherapy and Expert Opinion on Drug Safety. Three of the flagged papers were included in Saiz and his colleagues’ analysis. Collectively, the 12 papers have been cited more than 200 times, according to Clarivate Analytics’ Web of Science.

Given that the journals were contacted in October 2015 about two of the papers, we asked the publisher why it took more than two years to add an editorial notice to the papers. A spokesperson told us:

This has been a complex case with papers across journals, a number of co-authors, and references to other publishers. It is our responsibility to ensure we have conducted a thorough review, gathered input from all parties, and followed industry-wide best practice in our approach and decisions.

Taylor & Francis added:

We have investigated all papers authored by Dr. Derosa in the Expert Collection series of journals and are satisfied that no further action is needed beyond those papers where we have already published Expressions of Concern.

We contacted Derosa, but haven’t heard back. In 2015, he sent us a statement on behalf of he and his colleagues arguing that some of his papers that have been retracted were decidedly “different.”

Interestingly, Saiz and his colleagues’ article never mentions Derosa by name. Saiz told us that was a conscious choice:

…we are much more interested in facts than in individuals. There is nothing personal against him. At the heart of this controversy, Prof. Giuseppe Derosa is for us, above all, a symptom (among others) leading us to reflect on the whole scientific ‘establishment’.

Given that the papers focus on high blood pressure, Saiz shared more about the potential harm of so many alleged duplications:

In this particular case, studies are focused on the assessment of biochemical parameters. It’s true that they are no big and influential randomized clinical trials and no top journals were involved. However, these studies are part of the research done with marketed drugs used these days by doctors all over the world. Misleading articles can be wrongly included in systematic reviews, affect guidelines conclusions or even be used as marketing material in poor-evidence drugs.

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2 thoughts on “A distorted record on blood pressure drugs: Why one group is trying to clean up the literature”

  1. Most published research is false. The scientific ‘establishment’ has become a priesthood that is untouchable, very similar to medieval scholastics at oxford, cambridge, paris etc etc

  2. “This conclusion was based on the observation that different papers provided a large amount of identical data. In addition, the authors tried to mask redundancy by changing titles, tables and figures, and also avoided citing previous published articles on the same study”.

    I realize that ‘the devil is always in the details’, but based on the above descriptions I ask: How are these types of duplication not fraud? How are instances like these different from cases of data fabrication? Any identical data reported in the duplicates do not exist as the independent data that their authors are presumably trying to portray. As such, the scientific record has been distorted and must be corrected.

    Time to repeat my mantra: Data need to be treated as sacred objects and their provenance should never, ever come into question.

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