Two years after a journal told sleuths it wouldn’t retract flawed papers, it changed course and pulled them.
Mark Bolland, a researcher at the University of Auckland in New Zealand who is no stranger to unearthing academic wrongdoing, first sent complaints about one of the papers to The International Journal of Gynecology and Obstetrics (IJGO) in March 2021. He said the data on bone mineral density in “Isosorbide mononitrate versus alendronate for postmenopausal osteoporosis,” which has been cited 26 times according to Clarivate’s Web of Science, were “impossible.”
Bolland said the data the researchers reported were not consistent with the reference values provided by the maker of the device used to measure bone density in the study. The normal ranges are 0.96 +/- 0.12 g/cm2, whereas the experiment reported much lower values of 0.21-0.24 g/cm2.
In an email to Retraction Watch, Bolland’s colleague Andrew Grey called the data “laughable, frankly.”
A portion of the email Bolland sent to the journal reads:
The findings of this study which reported large effects of nitrates and alendronate are totally inconsistent with clinical trials from other groups, the lead author previously extensively plagiarized a report of another nitrate trial, and a systematic evaluation using the REAPPRAISED checklist raises a number of concerns about the integrity of the publication including concerns regarding trial ethics, participant recruitment and that the bone density baseline and outcome data are implausible or incorrect.
A spokesperson from the journal assured Bolland three times in September 2021 they had reviewed the data and found them to be correct – only for IJGO to retract the article two years later in December of 2023.
The lead author of the study, Ashraf Nabhan of Ain Shams University in Cairo, Egypt, was editor for Contemporary Issues in Women’s Health and systematic reviews until April of 2023. His name no longer appears on the editorial board. He currently sits on the senior editorial board for BMC Pregnancy and Childbirth, where 10 editorial board members resigned earlier this year because they felt the journal mishandled allegations of data fabrication. He didn’t respond to our request for comment.
But this wasn’t an isolated instance for IJGO. In March 2020, Grey notified the journal of issues with a second, unrelated article led by Indian researcher Subrata Seal. The paper, “Randomized controlled trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical dilation,” which has been cited 24 times, is part of a trio of papers by Seal published in different journals. Grey’s concerns included implausibly high reductions in relative risks for maternal outcomes, data discrepancies between study groups, and calculation errors.
The paper was used in a licensing document for a medical device called a fetal pillow in 2017, which is still available for purchase. In his email to the journal, Grey raised concern about the device being used clinically, even after the retraction: “According to the manufacturer’s website, the fetal pillow is now used in more than 20 countries and in >85 hospitals in the United Kingdom, and more than 26,000 devices have been used worldwide,” he wrote.
IJGO responded in October 2020 that all concerns had been investigated:
The authors provided responses to each of the concerns raised, and although they did concede that there were some errors in terms of timeline reporting, they gave satisfactory explanations regarding the different authors on the publications you mention, as well as the apparent discrepancy in study sites.
When Grey took the issue directly to the publisher, Wiley responded that it wanted to share his identity with the authors: “We feel this would be helpful in eliciting a more detailed response,” a representative said in December 2020. Grey did not respond, and didn’t hear anything for three years — until the paper was retracted in June 2023 for inconsistency in trial results.
The same spokesperson from the journal, Amy Goggins, told Retraction Watch that IJGO revisited the cases after appointing a research integrity editor in 2022. “We have re-opened investigation of some older cases where there was uncertainty over the outcome, in an effort to achieve consensus on these,” Goggins said.
Bolland said he was both surprised and not surprised that the original outcome was uncertain, “but they certainly never indicated any uncertainty in their correspondence with me- quite the opposite: they didn’t address the concerns we raised and simply dismissed them, without making any effort to engage with us about the concerns.”
In an email to Retraction Watch, Grey noted that the journal’s initial assessments were “extremely poor” for the articles. “Again, not unusual. The problems with the data and the publications were really obvious.”
IJGO published an expression of concern in January of 2023 regarding the fetal pillow paper. They also contacted the FDA to re-evaluate its licensing. Goggins told Retraction Watch that IJGO had been contacted by the manufacturer of the pillow device, Cooper Surgical, but didn’t share what the manufacturer said.
A representative from the FDA told Retraction Watch: “As a general matter, the FDA does not comment on potential or ongoing investigations.”
Not only were the cases similar — so were the retractions.
A portion of Nabhan’s retraction reads:
Concerns were raised by a number of third parties regarding the authenticity of the data and results presented in this study. In light of these concerns, the authors were asked to provide the raw data for the study. The authors cooperated fully and provided the raw data. Following review of the raw data by the journal’s research integrity team, it was found that there were highly similar sequences of values of in the data for the two study groups, suggesting duplication of data. Since the data of are incompatible with randomisation, this invalidates the study results and gives rise to considerable uncertainty around the observed effect of the intervention. As a result, the journal is issuing this retraction.
A portion of Seal’s reads:
Following the publication of an Expression of Concern on this article,1 further concerns were emphasized by a number of third parties regarding discrepancies between the retrospective trial registration and the published article. Following further review by the journal’s research integrity team, it was found that there were a considerable number of inconsistencies in the results presented. Unfortunately, there is no patient data available to explain or clarify these inconsistencies. This gives rise to considerable uncertainty around the benefit of the treatment intervention. As a result, the journal is issuing this retraction.
One other paper in Seal’s trio, “Does elevating the fetal head prior to delivery using a fetal pillow reduce maternal and fetal complications in a full dilatation caesarean section? A prospective study with historical controls,” was published in the Journal of Obstetrics and Gynaecology in 2014 and retracted in 2024. The third, “Outcome in Second- versus First-Stage Cesarean Delivery in a Teaching Institution in Eastern India” published in the American Journal of Perinatology, has not been retracted. Seal did not respond to our request for comment.
As for Nabhan, he has already lost one paper on the same topic. “A randomized clinical trial of the effects of isosorbide mononitrate on bone formation and resorption in post-menopausal women: a pilot study.” The paper was published in 2006 and, the same year, the journal made the “unusual decision” to retract due to “extensive plagiarism.”
Jim Thornton, an obstetrician-gynecologist at the University of Nottingham in the UK, left comments on PubPeer about another paper listing Nabhan as a contributing author, Thornton and his colleagues released a manuscript in October 2021 discussing the ethics of clinical trials led by Mohamed Sweed, a colleague of Nabhan.
Like Retraction Watch? You can make a tax-deductible contribution to support our work, subscribe to our free daily digest or paid weekly update, follow us on Twitter, like us on Facebook, or add us to your RSS reader. If you find a retraction that’s not in The Retraction Watch Database, you can let us know here. For comments or feedback, email us at team@retractionwatch.com.
I often wonder if anyone really reads these papers at all prior to publication. They should be more courteous to people who are doing an important part of their job for them, for free.