A paper published nearly two decades ago in Fertility and Sterility, an Elsevier journal, has been retracted after one of the co-authors admitted that the study had never actually been conducted. The recently published retraction notice has sent shockwaves through the academic community, raising concerns about research integrity and the long-term reliability of scientific literature.
Background and Retraction Details
The now-retracted 2006 article, titled “Psychological Assessment of the Effects of Treatment with Phytoestrogens on Postmenopausal Women: A Randomized, Double-Blind, Crossover, Placebo-Controlled Study,” was retracted following an admission by one of the co-authors that the study had not been conducted. Despite repeated attempts to contact the corresponding author, no response was received. Other co-authors and their institutions also failed to provide any contradictory information to refute the claim.
The retraction notice reads:
“The corresponding author did not reply to inquiries; however, one of the co-authors did respond and admitted that the study published above was not actually performed. Inquiries were made to the co-authors and their institutions, who did not provide any information to alter or contradict this admission. Therefore, the Publications Committee has determined to retract the article.”
The article, which has been cited 104 times, according to Clarivate’s Web of Science, had remained in circulation despite red flags raised by the scientific community.
Data Similarities and Ethical Concerns
This retraction follows an earlier discovery by research integrity expert Ben Mol and his colleagues, who identified striking data similarities between the 2006 study and an earlier 2004 paper by the same authors. The 2004 article, titled “Endometrial Effects of Long-Term Treatment with Phytoestrogens: A Randomized, Double-Blind, Placebo-Controlled Study,” contained an identical Table 1 to that in the 2006 study, despite the reported participant number being three times larger in the latter. The suspicious data similarities included identical mean height values of 165.5 centimeters with the same standard deviation—an anomaly that further fueled suspicions of misconduct.
Despite these concerns, the 2004 paper remains unretracted, raising further questions about its validity and prompting calls for a thorough investigation. Meredith Sauls, managing editor of Fertility and Sterility, declined to comment on whether the journal plans to probe the earlier study.
Authors and Institutional Response
The retracted paper shares two co-authors with the 2004 study:
- Vittorio Unfer, a professor at the International Medical University in Rome
- Maria Luisa Casini, currently a pharmacologist at the Italian Medicines Agency in Rome
At the time of the studies’ publication, both authors were affiliated with Sapienza University in Rome. Neither Unfer nor Casini has responded to media inquiries regarding the retraction.
One of the co-authors of the 2006 paper, Dr. Enrico Papaleo, a gynecologist based in Milan, previously distanced himself from a 2023 retracted paper by the same group, posting a public statement on PubPeer, saying:
“My participation in this study did not include clinical management of patients or database management. In view of the concerns raised, I no longer take responsibility for these papers.”
Despite this, Papaleo has not responded to recent inquiries regarding the current retraction.
Ongoing Investigations and Wider Implications
This is not the first instance of scrutiny surrounding the authors involved. In 2023, another paper by Unfer, Papaleo, and their colleague Guido Marelli, who was also a co-author on the retracted 2006 study, received an expression of concern in Gynecologic and Obstetric Investigation. The 2001 paper raised concerns due to reported similarities between the results presented in Figure 1 and Figure 2.
The journal’s publisher, Karger Publishers, has confirmed that they are aware of the 2006 article’s retraction and have launched their own investigation. Grainne McNamara, a publication ethics manager at Karger, stated:
“We immediately contacted the research integrity team at the publisher of Fertility and Sterility in December 2024 to request more information and the investigation remains ongoing.”
The retraction of the 2006 paper and the ongoing investigations into related studies highlight the persistent challenges of ensuring research integrity in scientific publishing. It also underscores the need for more proactive screening processes to detect potential fraud earlier and avoid misleading the scientific community.
The case serves as a stark reminder of the importance of vigilance in academic publishing and the long-lasting impact of misconduct on the credibility of scientific literature. Calls for greater transparency and accountability have intensified, with experts urging journals to implement stricter review processes and retrospective audits of previously published studies.
For now, the retraction of the 2006 study marks a step toward rectifying the academic record, but it remains to be seen whether further actions will be taken regarding the 2004 publication and others linked to the same authors.