A legal challenge by authors over three retracted articles about mifepristone is set for an arbitration conference this month as nationwide debate over the abortion pill heats up at the appellate level.
Ten researchers sued Sage in 2024 after the publisher retracted three of their papers about the purported dangers of mifepristone, a medication that ends early pregnancy. The authors alleged the company “applied inconsistent retraction standards” to their work based on Sage’s perception of their “pro-life affiliations,” in violation of California’s anti-discrimination law, according to their complaint.
The authors asked the Superior Court of California, County of Ventura to compel Sage into arbitration, as required by publishing agreements the researchers signed with the company. Arbitration is an alternative pathway for resolving disputes in which an arbitrator hears the parties’ arguments and issues a decision outside of the traditional court process.
The retraction notice for the articles, which were published in Health Services Research and Managerial Epidemiology from 2019 to 2022, stated the publisher removed them because of undeclared conflicts of interest by the authors. According to the notice, all but one of the article’s authors were affiliated with one or more 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.”
Further investigation by subject matter experts also found “fundamental problems with the study design and methodology” of two of the articles, and “unsupported assumptions and misleading” findings in the third article, according to the notice.
A federal judge in Texas cited two of the articles in his 2023 decision to temporarily suspend mifepristone. The U.S. Supreme Court ultimately rejected the suspension, allowing the medication to remain accessible while lawsuits in the lower courts continue.
One of those disputes is a current challenge by Louisiana against a rule from the U.S. Food and Drug Administration allowing doctors to prescribe mifepristone through telehealth and patients to receive it through the mail. State officials argue mifepristone should be available only in-person. A three-judge panel of the 5th U.S. Circuit Court of Appeals heard arguments in the case on Sept. 9.
In its complaint, Louisiana cites several studies about the risks of mifepristone, including a 2024 paper by James Studnicki, lead author of the three retracted papers, about emergency department visits following medication abortions among women in the Medicaid program. The three retracted articles are not referenced in the state’s complaint.
In court documents, the FDA attorneys stated the agency is conducting its own study of statistical data and safety outcomes about the medication. They also called the court challenge a “waste of judicial resources” while the agency’s review is ongoing and emphasized that Louisiana remains free to enforce its own state abortion restrictions.
The three retracted papers included articles about emergency room visits by women who use mifepristone, characteristics of physicians who perform abortions, and complications from chemical abortions, which now account for nearly two-thirds of all abortions in this country.
Over the last two years, the legal challenge by the authors has stalled while the plaintiffs and Sage sparred over choosing an arbitrator. Sage accused the researchers of attempting to exclude Sage from the arbitrator selection process. After several rounds of delays, the parties are scheduled for a status conference about the arbitration on Sept. 21, according to court records.
Studnicki previously told Retraction Watch the retractions were “a blatant attempt to discredit excellent research which is incongruent with a preferred abortion narrative.” The publisher removed Studnicki from the journal’s editorial board in the aftermath of its investigation. Studnicki, vice president and director of data analytics at the pro-life Charlotte Lozier Institute, told us he had no comment about the case until a final decision is reached.
Camille Gamboa, a spokesperson for Sage, told us the publisher had “no information to share at this time while the case is ongoing.”
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I have not read the articles, nor am I familiar with the science in question. But coming from a different discipline, my approach would be to add a statement of affiliations and conflicts of interest at the beginning of the article. If there are further methodological issues with the paper, it could be retracted. But this begs the question how the paper got through the peer-review process in the first place.
The authors all disclosed their affiliations and the journal knew them before publishing. It was ridiculous to claim that this was somehow an undisclosed conflict of interest. You might as well say that any academic with a particular point of view is conflicted on research involving that point of view. Next time a read an economics paper by a Marxist should I complain to the journal that he failed to disclose his Marxist beliefs as a conflict of interest ?
“The authors all disclosed their affiliations….”
That might not have been the issue —
“According to the notice, all but one of the article’s authors were affiliated with one or more 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.””
Apparently it was the COI that was the issue — presumably an editor is not expected to know whether every affiliation is a COI, and relies on a statement by the author(s).
> Next time a read an economics paper by a Marxist should I complain to
> the journal that he failed to disclose his Marxist beliefs as a conflict of interest ?
>
Well, this is (or was supposed to be) a biomed paper, not a social sciences one.
When is the COI a thought crime? If you believe in different development cutoffs for when homo sapiens can be killed? Check the COI box: consequentialist or personalist or utilitarian?
I still haven’t seen the specifics on why these were retracted other than a pearl clutch while gasping Charlotte Lozier’s name. Was there P-hacking? Sampling discrepancy? Alteration of Risk calculations? Where are the specifics?
The specifics are in the retraction notice, see e.g. https://journals.sagepub.com/doi/10.1177/23333928231216699
Beyond the undeclared CoI of the authors (people cannot just know that the Charlotte Lozier Institute is an explicit pro-life institute), the journal also managed to invite a peer reviewer who was associated with the same institute. That peer reviewer apparently did not declare this either.
And then there were apparent scientific issues with study design, data presentation and interpretation.
That is a remarkably detailed retraction notice and more than adequately addresses Thad’s remark.
I already read that boiler-plate retraction notice, it doesn’t address why it was retracted other than a thought crime, which Marco agrees with. A little bit of spit comes out of my mouth when I say “EXPLICIT pro-life INSTITUTE!!” to my gender studies colleagues. Supposedly a stats guy didn’t like tables 2 and 3 in one article but I don’t know why. Must have been the P-hacking. Or they flipped an odds ratio. Or they inserted a new furin cleavage site sequence and didn’t tell anybody. I don’t know.
Mr. Whiting: Perhaps you should stop clutching your own pearls, take a deep breath, and read more. For example (but not limited to) http://www.contraceptionjournal.org/article/S0010-7824(24)00070-2/fulltext
“And then there were apparent scientific issues with study design, data presentation and interpretation.”
This is a bit more than just “a thought crime”, so I do not agree with that at all.
The retraction notice points out that post-publication review by experts showed significant issues on these points. That it wasn’t detected during peer review might very well be because at least one reviewer conveniently forgot their obvious CoI.
Sounds like politics over science to me there’s always a stats guy with a complaint should not have been accepted if that’s the real cause not buying it
Of course Upadhyay wrote it. Anyone from UCSF/ANSIRH/Bixby center is funded by Buffet and by Packards who funded Danco labs to get the RU-486 to the U.S. They love abortion, they love depopulation. But nobody who wants to sit at the cool kids table is going to call UCSF an “explicit pro-abortion institute” and claim COI.
She states “any conclusion attempting to link ER visits to “morbidity” or adverse events was erroneous”. Could anyone else get away with that statement? She then tries to list reasons why ER visits are not really a big deal. The original graph still has a positive slope, she never denies this.
My favorite sentence in her article is “Because the authors included the total number of ER visits in the numerator over the total number of abortions in the denominator, the inclusion of multiple visits by individual patients produced an overestimation in their calculations of rates of ER visits”. This might be the stupidest sentence I have read this year because she tries too hard to hide her self-referential fallacy but it fails. Someone decides to measure “ER visits”, but really, truly should not count all the visits. Nobody would say this about ER visits after cholecystectomies, for example.
And further : “A more accurate representation of the incidence of ER visits would have considered only one ER event per abortion.” Move the goal post for Buffet!
“The study results were unclearly and incompletely written, and difficult to navigate even for the most experienced researchers”. In other words, this article is above my head so it needs to be retracted.
She doesn’t like the original graphs, there are 2 y-axes with different scales. Lots of research articles have these types of graphs and at first glance can be puzzling, until you analyze them like you are supposed to, and life goes on. So they got rid of the second scale. Still a positive slope. Still the same data points, just a different way of looking at the data. Still the same conclusion, which Upadhyay never denies.
I still do not see evidence for retraction.
Who funds the Charlotte Lozier Institute, Elliot Institute, and American Association of Pro-Life Obstetricians and Gynecologists? I don’t actually care, I’m just pointing out “who funds it” isn’t a great argument.
Nobody “loves” abortion or thinks it is a goal in and of itself. It is a consequence of sex that can be controlled through health care choices. People should be able to make the choice about pregnancy the same way people can choose their career, or cancer diagnosis, or diet, or romantic partner. Your body, your choice applies to cancer, broken legs, and cosmetic surgery – why not the decision to have a child?
The right to choose to have an abortion just recognizes the consequences of pregnancy and childbirth to the mother. Some pro-choice organizations do support depopulation, but for most it is about the right of people to consciously control their own lives and futures. Taking away that right means society is making choices for them. Based on your rhetoric, I assume you wouldn’t like it if the state chose your job, house, car, and partner for you – so why is it OK for society to remove one of the most consequential choices in life – whether or not you will be a parent?
Even basing the discussion on medical safety is deliberate deception on the part of most anti-abortion groups. Medical decisions balance risks (of pregnancy and childbirth versus birth control options) and benefits (which are essentially subjective to the pregnant person) on a foundation of patient autonomy. Most people and organizations who are anti-abortion are generally objecting on religious and political grounds and talking about safety is a flimsy pretense. The same approach applied to eating would forbit the sale of potato chips. Or more accurately, allowing Jewish and Muslim believers prohibiting the sale of pork.
That’s my point, WLU. Either call all parties out on the COI, or we stop pretending that one side gets special treatment. Gander Sauce.
What do you think about my point that forcing women to deliver unwanted babies is equivalent to prohibiting the sale of pork? Both involve using state authority to remove an adult’s choice based on a religious beliefs. Though generally Jewish and Muslim groups at least don’t pretend it’s for safety reasons.