A scientific sleuth and a mother who nearly lost her daughter to a hormonal condition teamed up in January to flag a series of papers that misnamed a medication for pregnant women. They have recently started to see the fruits of their labors: one retraction and three corrections.
In 2014, Tara Skopelitis, a lab manager at Cold Spring Harbor Laboratory, was given weekly progesterone injections to prevent preterm birth for her daughter, as reported by STAT. Six years later, after her daughter showed symptoms of an unknown hormonal condition which still hasn’t been formally diagnosed, Skopelitis discovered she should have received synthetic progesterone variant 17α-hydroxyprogesterone caproate, often referred to as 17-OHPC, 17P, sold as Makena. When the drug wasn’t available, her doctor had ordered the wrong replacement from a compounding pharmacy. Skopelitis suspects her daughter’s condition could be a result of the mixup.
The confusion lies within the literature, Skopelitis says: Many clinical trials and papers refer to 17P as intramuscular progesterone, as if they are interchangeable or even the same compound.
While 17P was FDA-approved for a time and had been tested in several clinical trials, “intramuscular progesterone has never been tested for safety or recommended for use in preventing preterm labor,” Skopelitis told us.
Skopelitis identified 69 papers that misname 17P as intramuscular progesterone. She enlisted the help of Sholto David, a sleuth and scientist who has helped manage their correspondence with the journals that published the papers. “It’s a story that forces you to sound like a conspiracy theorist. I had a hard time listening to Tara at first,” David told us in an email.
A recent retraction takes the duo a step closer to correcting the body of literature surrounding intramuscular progesterone. The Journal of Maternal-Fetal & Neonatal Medicine in June retracted the 2012 paper, “Matched sample comparison of intramuscular versus vaginal micronized progesterone for prevention of preterm birth.” This trial was a special case, however, since “the authors seem to have actually used intramuscular progesterone, under the impression that there simply is no difference to 17P,” David wrote in an email to a member of the editorial board in February.
Intramuscular progesterone at that dose “has never been tested for safety or even believed by anyone to be effective,” David wrote. “The entire premise of the study seems to have been based on a nomenclature misunderstanding.”
He also noted the authors compared their results to trials of intramuscular 17P, further evidence they believed the two compounds to be interchangeable, he said.
David forwarded the unanswered correspondence to the ethics department of the journal’s publisher, Taylor and Francis, in April. Julia Gunn, a research integrity manager at the company, responded in June that the paper had been retracted.
According to the retraction notice, when the journal reached out to the authors, they were informed that Mohamed Nabih EL-Gharib, the lead and corresponding author of the study listed as a researcher at Tanta University in Egypt, had died. The second author, T. M. EL-Hawary, also a researcher at Tanta University, “did not provide responses to our queries about the study, the raw data for review, or evidence to confirm that the study complied with the journal’s policies,” the notice stated.
EL-Hawary did not respond to our request for comment. He also publishes research under the name “Tarek Elhawary.”
“As for whether the trial actually happened, it’s certainly quite probable that it was just made up,” David told Retraction Watch in an email. Indeed, sleuths have identified many fabricated clinical trials in the obstetrics literature. If the drug was used as described in the study, “the consequences would be great,” David told us.
A slew of other articles that made the same nomenclature mistake have received corrections.
The paper that seemed to be the origin of the confusion, “Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate,” was published in the New England Journal of Medicine in 2003. The journal issued a correction in June 2024, after David and Skopelitis’ prompting.
The American Journal of Obstetrics and Gynecology MFM issued a correction for a 2020 paper in September, stating that “intramuscular progesterone should be replaced with 17α-hydroxyprogesterone caproate (17-OHPC) in the title and throughout the body of the paper.”
Also in September, a multi-article correction was issued by the American Journal of Obstetrics and Gynecology (AJOG). It applies to seven studies and controlled trials. The authors “regret that there have been instances where the terms progesterone and 17α-hydroxyprogesterone caproate (17-OHPC) have been used interchangeably,” according to the notice.
Roberto Romero, an editor-in-chief of AJOG, told Skopelitis in an email seen by Retraction Watch he contacted Elsevier, and “The Publisher agrees there is a need for corrections of all instances for which there are inaccuracies.” Elsevier did not respond to our request for comment.
“Hundreds of doctors lazily misnamed a drug and it was allowed to cascade through the peer reviewed literature with serious implications for patient care,” David told us. “That can’t just be an ‘oops’ moment.”
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