A journal and publisher have retracted three papers about abortion, including one that has been used in court cases to support the suspension of FDA approval for mifepristone, aka an “abortion pill.”
Sage, the publisher of Health Services Research and Managerial Epidemiology, announced the retractions yesterday and posted a retraction notice covering the three articles.
For one of those articles, initially flagged by a reader, “an independent reviewer with expertise in statistical analyses evaluated the concerns and opined that the article’s presentation of the data in Figures 2 and 3 leads to an inaccurate conclusion and that the composition of the cohort studied has problems that could affect the article’s conclusions,” according to the notice.
The notice also said Sage “confirmed that all but one of the article’s authors had an affiliation with one or more of Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists, all pro-life advocacy organizations, despite having declared they had no conflicts of interest when they submitted the article for publication or in the article itself.”
One of the peer reviewers, Sage learned, “was affiliated with Charlotte Lozier Institute at the time of the review,” leading the publisher and journal editor to determine “the peer review for initial publication was unreliable.” That referee also reviewed the other two now-retracted papers, according to Sage.
James Studnicki, the lead author of the three papers, told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” He told The Daily Wire, a conservative news outlet that was first to report on the retractions, the move was “completely unjustified.” The Daily Wire notes that “The Supreme Court is set to hear arguments in March on the legality of restricting the abortion pill based on [Judge Matthew] Kacsmaryk’s ruling, proceedings that will certainly be impacted by the retractions.”
Sage had subjected one of the papers to an expression of concern in August 2023, saying they were investigating “potential issues regarding the representation of data in the article and author conflicts of interest” after being alerted by a reader. As News From The States reported then, the notice came after Chris Adkins, a professor at South University who teaches pharmaceutical sciences, raised concerns with Sage. As News From The States noted in August:
Kacsmaryk leaned hard on a 2021 study that was designed, funded and produced by the research arm of one of the most powerful anti-abortion political groups in the U.S. The judge cited this paper — which looked at Medicaid patients’ visits to the emergency room within 30 days of having an abortion — to justify that a group of anti-abortion doctors and medical groups have legal standing to force the FDA to recall mifepristone.
In a point-by-point response to Sage’s critiques of the paper sent to the publisher in November and now shared with Retraction Watch, Studnicki and colleagues pointed out they had noted their affiliations in the original manuscript and the then-proposed retractions “misrepresent ICMJE disclosure standards,” referring to the International Committee of Medical Journal Editors’ guidelines. They also call some of the post-publication peer reviewers’ critiques “factually incorrect” and “unfounded.” They conclude:
- No single specific finding in any of the three papers has been explicitly challenged, let alone invalidated.
- There is no evidence of a major error, miscalculation, fabrication, or falsification.
- There is no breach of any of the COPE guidelines that could permit Sage to retract any of our published papers.
- The retraction of any of these papers, let alone all three, is demonstrably unwarranted.
Adkins told Retraction Watch he is “pleased the journal approached my concerns with legitimate and serious consideration.” He continued:
It is reassuring that my initial concerns with the 2021 Studnicki et al. article were verified and affirmed by other experts. Despite the length of time spanning my initial communications with the journal and today’s retractions, I understand that thorough investigations and re-review processes take time. Given that these now-retracted articles have been excessively cited by parties involved in ongoing federal judicial cases, now positioned before the SCOTUS, Sage’s retractions should help our courts remain informed by the highest standards and quality in scientific and medical evidence.
Update, 2/6/24, 2100 UTC: We note that — contrary to best industry practices described by the Committee on Publication Ethics — Sage has removed the original versions of the articles.* They are available at these links:
- “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015“
- “Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges“
- “A Post Hoc Exploratory Analysis: Induced Abortion Complications Mistaken for Miscarriage in the Emergency Room are a Risk Factor for Hospitalization“
Update, 2/7/24, 2100 UTC: Sage notes that the articles are still available, but “admittedly not so easy to get to – something we are working on with our platform provider.” To find the originals, click on the “PDF / ePub” link in the relevant article, switch the view to ePDF from ePub once the page opens up, and scroll to the third page, past the retraction notice.
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 [email protected].
Do we support reviewer affiliation checks for all science topics? Should journals ensure that peer reviewers of global warming papers have never donated to the NRDC?
I think there is a distinction to be made if science and peer reviewers are being funded by the same organization or a peer reviewer donating to the org that financed the paper they are reviewing. Or am I missing something?
all pro-life advocacy organizations
Scare quotes around “pro-life” might be appropriate here, or the use of a less loaded term such as “anti-abortion”.
I don’t mind the word anti-abortion, so long as the “pro-choice” folks get referred to as pro-abortion, since many of them are.
How about “forced birther” while we’re at it?
How about “pro-death” while we’re at it?
We seem to agree that loaded labels – ones that presume the truth of an argument – are intellectually dishonest.
Anatomy of a scandal
Back in 2000, the FDA was manipulated into abandoning the thoroughness of its standard safety investigation regime.
It adopted instead the accelerated approval for emergency medications which had been introduced in the nineties to fast-track new experimental drugs to deal with, inter alia, the alarming HIV/AIDS outbreak.
The sponsors of the abortion pill, the Population Council and Danco, the manufacturers, opportunistically jumped on the expedited bandwagon.
The FDA, under political and media pressure, reneged on its duty of care and claimed an exaggerated emergency need for this drug to be approved. They placed healthy pregnancy in the same emergency basket as the AIDS epidemic. The usual careful regimen was rashly hurtled through this newly instituted “priority review” process.
Research history on Mifepristone drug—inadequate information
Take a look at some of the mistakes made.
1. In 1996, the Population Council filed a new drug application for mifepristone with FDA. The real result, after four years of review following the proper protocols, was a thumbs down—the drug’s distribution could not be declared safe. This result, recorded in a letter, dated February 2000, to the Population Council (the chief advocate for this abortion pill) stated that
“adequate information has not been presented to demonstrate that the drug, when marketed in accordance with the terms of distribution proposed, is safe and effective for use as recommended.”
2. On June 1, 2000, FDA sent another letter to the Population Council setting out proposed restrictions to address serious safety issues. Doctors were to be “trained and authorized by law” to perform surgical abortions. Doctors needed training in administering mifepristone and treating adverse events; and doctors were to have “continuing access (e.g., admitting privileges) to a medical facility equipped for instrumental pregnancy termination, resuscitation procedures, and blood transfusion at the facility or [one hour’s] drive from the treatment facility.”
3. “When FDA’s proposal was leaked to the press, a political and editorial backlash ensued.” ( Kacsmaryk)
4. “In response, the Population Council rejected the proposal and repudiated the restrictions the sponsor itself proposed in 1996 — what FDA deemed a “very significant change” in the sponsor’s position. Because “[t]he whole idea of mifepristone was to increase access,” abortion advocates argued that restrictions on mifepristone “would effectively eliminate” the drug’s “main advantage” and would “kill[] the drug.” (Kacsmaryk)
5. Only a few months later, in September 2000, FDA reneged on its safety proposals and gave in to the objections of the Population Council and Danco. Despite its “serious reservations” about mifepristone’s safety, FDA “concluded that there was no need for special certification programs or additional restrictions.”
6. In September 2000, FDA’s February assessment earlier that year was abandoned—replaced with a set of safety precautions that waived the requirement for assessment of the safety and effectiveness of the Misopristol on pediatric patients.
“Be advised, as of April 1, 1999, all applications for new active ingredients, new dosage forms. new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product on pediatric patients unless this requirement is waived… We are waiving the pediatric requirement for this action on this application. “
7. Sixteen years later, safety precautions adopted originally in lieu of “adequate information” originally demanded by the FDA were further relaxed.
8. In 2021, safety precautions were so relaxed that Mifepristone could be sent through the post to be self-administered.
There is real scandal in the fact that the FDA has ignored the genuine dangers that without the original requirements, some users will not be able to confirm pregnancy and gestational age, to recognize ectopic pregnancies, or to identify coerced abortions particularly in victims of abuse or human trafficking.
Great information to have, especially regarding the shady way they’re trying to get around this issue, thank you for that!
See this interesting article for a longer discussion:
https://arstechnica.com/science/2024/02/anti-abortion-groups-studies-retracted-before-supreme-court-mifepristone-case/
COPE gives a very limited set of circumstances under which a retracted article may be removed from print. Additionally, it clearly states that the “retraction notice should clearly state why the full article has been removed” (Sage did not do this). Ignoring that, this paper fits into none of the categories that COPE outlines. Obviously, no defamation or violation of personal privacy occurred, and the court case is on the topic of the drug itself, not these papers. The only acceptable category this retraction could fit in is “serious health risk to the general public” (a moot point because again, Sage already violated COPE policy by not providing a written explanation of why they took the extra step to remove the articles), but I personally don’t believe that this provision really applies because mifepristone is rarely used for medically necessary abortions anyway.
I was willing to give Sage the benefit of the doubt on this retraction, but the fact that they didn’t even try to explain why they took the extra step of removing the article from print makes me feel like this is being done in bad faith.
this is something unacceptable.
for me the major mistake come from publisher, not author or reviewer.
author prepare paper and submit it in official submission platform. so, the editor of publisher is responsible to find the proper reviewers and invite them. next, the editor will decide either accept or reject.
why in current practice, all blame will goes to author or reviewer?
the publisher received plenty of dolars from APC or subscribers. and when there some mistake, publisher point the blame to other.
i thinks this is the time to point all blame for all misconduct to the publisher. they are the one who accept and published the paper.
Correct statement.
Ah the USA. A magical land where your life only matters to the government before you’re born. And only for political and religious reasons. As someone put it, the richest developing nation in the world;-)
This is so condescending and inappropriate. I’m an ardent atheist and think casual abortion has grave moral implications precisely because I believe human life is all anybody gets of meaning in the universe. And as seen here, it has been politicized in the extreme in the other direction. Instead of acknowledging that abortion is at least morally questionable, treating it as anything other than a dogmatically unquestionable good is forbidden. If the papers’ analyses are wrong, let me see the analyses and errors. Instead, all I see is hidden papers, unacademic weasel-word phrases like “experts agree” and “potentially unreliable”. Let’s see the original and the specific errors which supposedly merit retraction. If you don’t want science politicized, treat even controversial issues scientifically instead of politically.
The scientific press needs to figure out how to push retractions through the system. Every subsequent article that cited/cites this article needs to have that citation appended to indicate retraction. Otherwise a retraction becomes buried and forgotten. I would read an article more critically (on the first read) if I knew ahead of time that one of the studies it cites had been retracted.
Ideal way to refute a science paper is to publish a “Comment on” paper by those who think the articles are scientifically inaccurate – it can be politically inaccurate. This is what “Chris Adkins, a professor at South University who teaches pharmaceutical sciences” should have done, rather than arm twisting the publisher to retract.
I do not see why these articles need to be retracted. At the least an update to COI or at the drastic most an Errata from publisher’s end to state that the Author’s COI and reviewer’s COI were missed to be noted from their end.
Relevant: Why a publisher retracted abortion-pill studies cited in a case set for the Supreme Court
Nature spoke to researchers about the flaws that triggered the retractions. They say these papers are just the tip of the iceberg.
https://www.nature.com/articles/d41586-024-00556-0
I am a retired OB/GYN clinician/scientist and have done many medical and surgical pregnancy terminations. One cannot directly compare emergency department visits after medical or surgical pregnancy terminations to determine significant health risks without a very deep dive into the individual emergency department visits and their outcomes. A surgical termination in the office or hospital is a procedure that uses adequate anesthesia or analgesia. There is little to no physical discomfort prior to or after the procedure. After surgical termination subsequent visits for pain or vaginal bleeding to emergency departments are unusual. Medical terminations, on the other hand, involve a procedure that by design, after oral medication is used, will inevitably cause bleeding and cramping at home. Prior to initiation of treatment patients are selected based on their medical status, ability to tolerate the pain and vaginal bleeding they will encounter, availability of support at home and absence of significant barriers to followup care. Detailed counseling, instructions and pain medication are provided. Most patients will abort at home but some will experience pain and/or bleeding that although not medically significant is distressing enough to cause an emergency department visit. I have seen many such patients and in under a minute removed aborted tissue sitting in an open cervix. Typically patients are discharged home without much further pain or bleeding. This type of emergency department visit is an expected, although undesired, aspect of medical termination of pregnancy and in most cases does not result in significant complications. This is why just the frequency of emergency department visit after medical pregnancy termination cannot be used as a proxy for significant method related complications. To determine the relative risk of each termination method for significant complications the diagnoses, cost and outcome of each emergency department visit must be examined in detail.
I was intrigued by the news that the lobby group who funded the research and reviewed the papers for publication are also paying one of the judges who agreed that the papers were enough to suspend mifepristone.
https://www.theguardian.com/world/2024/mar/25/judge-james-ho-wife-mifepristone-abortion-pill
Thank you for this very useful comment.