Critics face legal threats as journal takes more than three years to act

More than three and a half years after being alerted to concerns about the data in a 2015 article, an obstetrics journal has finally retracted the paper, citing a lack of ethics approval for the work. Meanwhile, the co-author of a meta-analysis that relies heavily on the paper has suggested that some critics of the underlying work risk legal action for their efforts.

The study, “Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety,” appeared in Archives of Gynecology and Obstetrics (AGO) and was conducted by Waleed El-refaie, Mohamed S. Abdelhafez and Ahmed Badawy, of the University of Mansoura in Egypt. The article has been cited 29 times, according to Clarivate Analytics’ Web of Science.

As we reported last October, data sleuths have accused Badawy and some of his colleagues at Mansoura of having fabricated data and other misconduct in some 250 clinical trials — charges which were (and may still be) apparently convincing enough to warrant a university inquiry. 

By our count, Badawy now has seven retractions and a slew of editor’s notes, including three recent expressions of concern in Acta Obstetricia et Gynecologica Scandinavica. 

In a November 2017 e-mail, Ben Mol, then a professor of obstetrics and gynecology at the University of Adelaide and now at Monash University, in Australia, alerted the editor-in-chief of AGO to several of what he considered to be “impossible findings” in the article. (Mol and two co-authors lay out their approach to analyzing randomized controlled trials for potentially fabricated data in a new paper in Obstetrics & Gynecology.)

At the time, the editor, Olaf Ortmann, invited Mol to submit a letter to the journal detailing his concerns — an invitation Mol eventually declined. As he told us, “The official procedure is to express concern to the editor and not to write a letter-to-the-editor.”

Mol and roughly 10 other researchers from around the world reiterated their concerns to Ortmann in a December 2019 letter, in which they stated that “we highly suspect that either all or a large proportion of the patients claimed to have been enrolled in the study were actually fabricated.”

The letter goes on to say that the journal: 

has taken too long [to deal with the article] and that we should consider the risk to women who may be treated based on this publication while we are awaiting resolution. As such, we feel that it is time to make a decision as to whether our concern should be disclosed to the public and that [the delay is] unacceptable  

Yet more delay would follow. 

According to the retraction notice, which was issued July 27: 

The Editor-in-Chief has retracted this article. Contrary to the statement in the article, the authors did not obtain approval from a research ethics committee before conducting this interventional randomized control trial and therefore this study is in breach of the Declaration of Helsinki [1] and the editorial policy of the Journal. Concerns about the data reported in the article are under investigation by the University of Mansoura. Waleed El-Refaie stated on behalf of all co-authors that they do not agree with this retraction.

Mol said he was frustrated by the notice for its failure to mention issues with the data: 

Interesting that this journal relies for the further investigation on a University (Mansoura) that allowed research without appropriate ethics. But the whole study is fake of course; it never happened. The other funny/concerning issue is that so few people are willing to speak out.

In response to a request for comment, Badawy told us that he had “nothing to do with this paper” and that his co-authors: 

have a strong reply to the journal and legal action against academic racism also against the editors

When pressed, Badawy clarified that “Sure I was involved” with the paper, but warned us:

not to involve yourself in an incorrect way as there is still a legal debate about the racistic action of the journal

Mol noted that the now-retracted article provides significant support for the conclusions of a 2017 meta-analysis in Ultrasound in Obstetrics & Gynecology by a group led by Roberto Romero, of the U.S. National Institutes of Health and Wayne State University in Detroit. 

He alerted the authors to his concerns about the paper in 2019, without success. In emails Mol forwarded to Retraction Watch, Romero’s co-author, Agustin Conde-Agudelo, also of NIH and Wayne State, defended the Mansoura researchers and said Mol might face legal action: 

Your actions and multiple emails can be proven to be fraudulent misrepresentation. This tort emerges when there is evidence that statements you made are not only false, but you knew they were false. In some jurisdictions, you would be found liable merely you should have known that your statements are false. Therefore, your repetitive falsehoods magnify the damages you have inflicted on others. 

Neither Romero nor Conde-Audelo responded to a request for comment.

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