Fecal transplant paper pulled for “personal issue”

Last month, the Journal of Pediatric Gastroenterology and Nutrition pulled an article on fecal transplantation for a reason that, well, doesn’t pass the sniff test.

The paper, by Sonia Michail of Children’s Hospital Los Angeles, appeared online in October 2017 and described a randomized controlled trial of fecal transplants to treat kids with ulcerative colitis. (If you’re interested, here’s an overview of how fecal transplantation works.) The trial, or one awfully like it, is listed on ClinicalTrials.gov, and shows Michail as the lone investigator on the study, which is aiming to gather more than 100 participants.

But the journal retracted the article — which was the subject of a laudatory editorial in the journal pointing readers to the findings — with an entirely opaque statement, saying that the work   

Has been retracted by the editors and publisher per author request.

That’s not exactly best practice in the publishing industry — the Committee on Publication Ethics, for instance, asks journals to provide explanations for retractions. So we emailed Wolters Kluwer, which publishes the JPGN, and asked them about the less than informative notice for “Fecal microbial transplant in children with ulcerative colitis: a randomized, double-blinded, placebo-controlled pilot study.” Mel Heyman, the editor of the journal, sent us this response:

The retraction was at the request of an author due to a personal issue. The journal — the official publication of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition  — did not identify any misconduct, but the author requested details not be included in the retraction.

Which didn’t clarify much.

To be fair, the journal has done a somewhat better job with several earlier notices. In April, it published a fairly detailed expression of concern about a different paper and in 2014 it issued a somewhat less thorough retraction of this 2014 article. Same with this 2012 paper.

In 2013, the journal retracted a 2012 article

after finding issues related to the institutional review board approval of the project.

Michail has published more than 70 papers, according to Medline. We attempted to contact her multiple times but received no reply.

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One thought on “Fecal transplant paper pulled for “personal issue””

  1. Personal issue?

    If you look at the trial registration changes (scroll to the bottom) it appears the sponsor or investigator didn’t believe it was subject to FDA investigational new drug (IND) regulation. This is why there is no “Health Authority” field in the registration.

    FDA regulations do apply: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM488223.pdf

    The IRB should have caught that. If this registration is for the retracted paper, why is the trial still recruiting subjects? Was the paper reporting early results? Hard to see how to do this with a placebo-controlled trial.

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