Chris Adkins is worried.
The Georgia pharmaceutical sciences professor who sparked an investigation into scientific studies that led to recent news-making retractions is worried about the “appropriate legal action” researchers have vaguely told media outlets they’re pursuing.
But even more than being sued, Adkins is worried it might be too late to correct the scientific record about a key abortion drug in a high-stakes legal case that is currently before the U.S. Supreme Court. Because before the three studies produced by an anti-abortion think tank were probed and determined to have “fundamental problems with the study design and methodology,” two of them were directly cited by a federal judge in ruling the plaintiffs had legal standing in seeking to strip mifepristone of federal approval. And now the anti-abortion researchers have claimed the retractions are a result of pro-abortion politics while downplaying their own significant roles in the consequential case.
“The main concern is that now, instead of focusing on the science, it’s going to be contorted and twisted as a political maneuver,” Adkins told States Newsroom in a phone interview. “I don’t mind my name being thrown out there. … But my initial concern was driven purely by the issues I had with the very science and the communication of that science.”
GET THE MORNING HEADLINES DELIVERED TO YOUR INBOX
SUBSCRIBE
On Feb. 5, academic publisher Sage Journals announced it was retracting three of Charlotte Lozier Institute’s studies about abortion published in the journal “Health Services Research and Managerial Epidemiology” between 2019 and 2022. Among them was research that questioned the safety of mifepristone, a commonly used abortion and miscarriage medication. The reasons Sage cited included undeclared conflicts of interest involving several of the papers’ authors, who had an affiliation with “pro-life advocacy organizations that explicitly support judicial action to restrict access to mifepristone.” Some of the authors are plaintiffs or expert witnesses in the lawsuit.
Study cited by Texas judge in abortion pill case retracted
While Adkins and California-based epidemiologist and reproductive health expert Ushma Upadhyay work to publish a scientific examination of the now-retracted research and the Supreme Court hearing looms large, experts say the nation’s highest court is unlikely to give serious consideration to the exposed ambiguities in a decision that could have repercussions beyond reproductive health care.
From the beginning, reproductive health, pharmaceutical, and legal experts have warned that an outcome in favor of the anti-abortion medical groups and doctors who sued the U.S. Food and Drug Administration in November 2022 could limit access to mifepristone with a decadeslong record of safety and efficacy — and upend federal drug policy in the process.
“The failure to routinely engage in rigorous vetting processes undermines the integrity of our judicial system and raises concerns about our federal courts’ ability to appraise scientific and medical evidence presented in their courtrooms,” Adkins told States Newsroom in a follow-up written statement.
The Charlotte Lozier Institute, the nonprofit research arm of the anti-abortion powerhouse Susan B. Anthony Pro-Life America, employs scholars who for decades have produced research used to defend anti-abortion laws. That work included the 2021 article that U.S. District Judge Matthew Kacsmaryk cited as evidence that plaintiffs had standing to sue and was published exactly one year before they filed suit in Amarillo, Texas, one of the most conservative federal district courts in the country. A couple months before filing the lawsuit, they registered a nonprofit called the Alliance for Hippocratic Medicine, which became the lead plaintiff in the case. The principal officer of the Alliance, according to the Internal Revenue Service, is Dr. Donna Harrison, an OB-GYN and the recently retired CEO of the American Association of Pro-life Obstetricians & Gynecologists (AAPLOG), which is also a plaintiff. Additionally, Harrison is one of the authors of three retracted studies.
The Charlotte Lozier Institute scholars have vigorously defended their research, while downplaying their significant roles in the FDA lawsuit.
“What happened to us has little or nothing to do with real science; it has everything to do with political assassination of good science,” said James Studnicki, Charlotte Lozier vice president and director of data analytics, in a video uploaded to a website the group recently launched to challenge the retractions. Studnicki was the lead author of the three retracted studies and an expert witness for the three red states that tried to intervene in the lawsuit alongside plaintiffs. The Supreme Court on Tuesday denied Missouri, Kansas, and Idaho’s motion to intervene.
Studnicki and Charlotte Lozier Institute senior research associate Tessa Longbons told States Newsroom in a written statement that this is a “baseless ideological attack” and that Sage has never “identified a single substantive objection to the studies.”
Meanwhile they maintain that the Supreme Court can overturn FDA policy on mifepristone on the basis of their work.
“The Supreme Court can rely on our findings,” Studnicki recently told Science magazine.
Experts also have said they don’t believe the retractions will affect the Supreme Court’s ultimate decision.
“There’s been a lot of people who’ve been criticizing the science used [by plaintiffs] as junk science. And I think this is just further proof that it’s junk science,” Drexel University law professor and reproductive rights advocate David Cohen told States Newsroom. “That being said, I think that the judges will find a way to support the view that they feel like they want to reason towards, and two studies disappearing is not going to change that.”
A case that hinges on science
It took about four years before the U.S. Food and Drug Administration approved mifepristone in 2000 as part of a two-drug abortion regimen for first-trimester abortions: The mifepristone is taken first to block the hormone progesterone, followed by the ulcer medication misoprostol which causes the uterus to contract. After nearly two decades of data showing the regimen has a high rate of efficacy and a low rate of serious adverse events, the federal agency lowered the dosage and loosened restrictions.
But the Alliance for Hippocratic Medicine asked federal courts to order the FDA to revoke its approval of mifepristone, or at minimum roll back more recent changes authorizing its availability via telemedicine and at pharmacies.
The case began with an initial victory for plaintiffs in district court, when Kacsmaryk ruled to suspend mifepristone’s FDA approval. The U.S. 5th Circuit Court of Appeals overturned the full drug suspension, but upheld the lower court decision to reinstate outdated restrictions. The U.S. Supreme Court will hear the case March 26.
Going back to the pre-2016 regimen in practice would mean shortening the gestational window the drug can be used, from 10 to seven weeks. It would require three in-clinic appointments and prohibit telemedicine and pharmacy dispensation. The old regimen also calls for a higher dose of mifepristone, which goes against current recommended guidelines.
Reproductive health experts say these FDA rollbacks would limit access to even more people, now that abortion is banned or heavily restricted in nearly half the country.
As States Newsroom has previously reported, the plaintiffs’ submitted evidence that mifepristone is a high-risk drug includes a small number of studies produced by a small anti-abortion medical community, along with anecdotes by the doctor plaintiffs. Defendants, in contrast, have submitted hundreds of studies.
The failure to routinely engage in rigorous vetting processes undermines the integrity of our judicial system and raises concerns about our federal courts’ ability to appraise scientific and medical evidence presented in their courtrooms.
– Chris Adkins, pharmaceutical professor
Adding to this pool of research is a brand-new study in “Nature Medicine,” co-authored by Upadhyay, an associate professor at the University of California San Francisco, which found a low rate of serious abortion-related adverse events for patients who took medication abortion via telemedicine.
But none of that has stopped the plaintiffs’ legal team, the powerful Christian right Alliance Defending Freedom (a funding source for the Charlotte Lozier Institute and co-plaintiff AAPLOG), from asserting publicly and in court that mifepristone is dangerous. One of the plaintiffs’ key claims that stems directly from the 2021 paper is that emergency room visits within 30 days following a medication abortion increased 500% from 2002 to 2015.
In this study, researchers looked at Medicaid data in 17 states between 1999 and 2015. They tracked patients who had had a procedural or a medication abortion and counted each time they went to an emergency department in the 30 days following those abortions.
Upadhyay said among her main concerns with the 2021 paper is that the researchers inflated their findings, and appear to conflate all emergency department visits with adverse events. She said they lumped in people going in for just observation to make sure bleeding is normal with people who needed significant intervention.
“A national study found more than 50% of ER visits after abortion involve observational care only — indicating that an adverse event did not occur. But even a visit that involves an aspiration procedure to treat retained products of conception after an abortion is not considered a true complication. It is expected that about 3-5% of people who have a medication abortion will require an additional procedure to complete the abortion,” Upadhyay told States Newsroom in a follow-up written statement. “Studnicki et al. sensationalize and obfuscate the growth in ER visits after medication abortion. The authors downplay that their data demonstrates the vast majority of postabortion ER visits were not abortion-related (based on ICD-9 codes) and abortion-related ER visits were uncommon.”
The Charlotte Lozier authors defended their study design in a rebuttal to Sage, and argued that abortion complications are typically underreported. “The ER visit can be for any number of complications and is, therefore, a broad proxy indicator for abortion-related morbidity,” they wrote.
Adkins said also problematic was how the authors communicated their findings, ultimately concluding “mifepristone abortion is consistently and progressively associated with increased morbidity.”
“You know, scientists, we get so enrapt, and enveloped in our work, that we forget that the very language we use to describe our work is sometimes foreign to others,” Adkins said. “We have a duty to communicate our findings in a way that is accurate, honest, and can be interpreted by all. That’s difficult. And I think that the Studnicki articles, I think there are portions of it that take advantage of that to generate misinterpretation, and that is then turned around and used to fuel these lawsuits.”
Based on Adkins’ concerns, Sage re-examined the peer review process and found that one of the initial peer reviewers was an associate scholar with the Charlotte Lozier Institute. The publisher then enlisted a statistician and two reproductive health experts to newly peer review the Charlotte Lozier articles.
“Following Committee on Publication Ethics (COPE) guidelines, we made this decision with the journal’s editor because of undeclared conflicts of interest and after expert reviewers found that the studies demonstrate a lack of scientific rigor that invalidates or renders unreliable the authors’ conclusions,” reads Sage’s public note on the retractions.
As part of their rebuttal to the retractions, the Charlotte Lozier team has said the process is double-blind, so the researchers couldn’t have known who the peer reviewer was.
Studnicki was on the journal’s editorial board until last fall, but the journal’s editor-in-chief dismissed him after the journal and Sage decided to retract the papers.
“The editorial board members at HSRME (Health Services Research and Managerial Epidemiology) act as ambassadors of the journal and in turn, of the Publisher to help uphold the highest standards of quality and integrity in scholarly publishing,” Dr. Gregory M. Garrison wrote Studnicki in an email dated Nov. 14, 2023, and shared by Charlotte Lozier. “In light of the decision to retract three research articles where you are an author, I believe that your term as editorial board member must now come to an end.”
The Charlotte Lozier team has insisted the retraction of their research is based on politics rather than science. But research experts say retraction is a high bar to clear, and journals are reluctant to retract in fear of lawsuits.
Ivan Oransky, who teaches medical journalism at New York University and co-founded the blog Retraction Watch, told States Newsroom that retractions are slightly on the rise because of the rise of fraudulent paper mills. But he said a lot of mediocre science goes under the radar unless someone brings it to the attention of the journal.
“There are an awful lot of other papers that should also probably be retracted,” Oransky said. “If you were to hold all papers to the same actual standards, far more would be retracted.”
Conflicts of interest
In their Assault on Science website, the Charlotte Lozier team refers to Adkins, an associate professor and director of assessment at South University School of Pharmacy* in Savannah, Georgia, as someone who “supports abortion.”
As Adkins told States Newsroom last year, the fall of Roe v. Wade on his birthday coupled with a baby on the way made him more concerned about reproductive rights. But the once conservative Texan said he had never formally advocated for abortion access. In his spare time, he reads FDA news, which is how he eventually fell down a rabbit hole trying to understand how this research was produced and whether it was ideologically biased. After reaching out to the journal and publisher, Adkins started consulting with reproductive health experts and earlier this year was invited to sign onto an amicus brief filed in the FDA case, of over 300 reproductive health researchers, defending the science behind mifepristone. Adkins maintains that his major issue in this case is the lack of quality in the science used by plaintiffs.
“My decision to notify Sage was prompted following a federal district judge’s citation of the 2021 article, wherein language was used that was inconsistent and inaccurate relative to the cited work,” Adkins told States Newsroom. “I believe it is both a professional obligation and a right to bring attention to legitimate concerns within scientific and medical literature; this practice is not ‘activism’ — instead, it is the self-correcting feature of scientific progress.”
The Charlotte Lozier researchers have objected to a larger accusation of an ideological conflict of interest, arguing that many authors of reproductive health articles that have been published in Sage journals also advocate for abortion access.
But Sage defended its retraction decision.
“Investigations are often initiated from readers’ complaints, as was the case in this matter regarding an issue of the presentation of data, and in the course of the investigation the undisclosed conflicts of interest became glaring,” Sage attorney Ronni Sander wrote to Charlotte Lozier attorney David A. Shaneyfelt in a letter dated Nov. 21, 2023, published on the Assault on Science website. “However, the substantive findings by the reviewers were most significant in the determination that retraction of the articles was necessary under COPE … guidance.”
Upadhyay says she agrees that most authors, including herself, are biased toward certain policy outcomes but are called as scientists to follow the science rather than their biases.
“As a health-care researcher, I have an interest in expanding access to abortion, because I believe abortion is health care,” Upadhyay said. “So everyone is going to come to a question with their own set of beliefs. … For me, the conflict of interest is more about the fact that Studnicki was on the editorial board and that the peer reviewers [it was only one peer reviewer, according to Sage] were from the same institution. And most importantly, that they can approach the research question with scientific integrity … that they acknowledge their bias but they still stick to scientific rigor. And that they did not do.”
And while the authors did declare that they were affiliated with the Charlotte Lozier Institute, they did not disclose the extent several of them are directly involved in the mifepristone lawsuit. Or that they received funding from the law firm suing the FDA.
The Alliance Defending Freedom in 2021 donated more than $27,000 to the Charlotte Lozier Institute and $25,000 to AAPLOG. Among the Charlotte Lozier’s “core activities” reported in its 2022 tax filing include producing white papers and studies cited in the case that overturned Roe v. Wade and in post-Roe cases since: “After the Court’s ruling in June 2022, CLI provided expert commentary and information in media and policy forums across the nation, contributing to the restoration of protective laws in place before the 1973 Supreme Court rulings in Roe and Doe.”
The filing also specifically references the research published in their 2021 paper: “Leveraging millions of data points from Medicaid claims data, Charlotte Lozier Institute scholars identified a dramatic spike in abortion pill related emergency room visits.”
Influence of the retracted science
Upadhyay says that even if the retractions ultimately have no legal impact on the case, they matter.
“There’s a court of public opinion,” Upadhyay told States Newsroom. “If the public is made aware that this article was retracted and yet this article is part of the reason the plaintiffs have standing, I think that it will become even more clear that the ultimate decision the Supreme Court makes, if they do rule against access to mifepristone, it will become more clear that that decision was not based in science. So I still think it’s important that it was retracted before the deliberation.”
Attorneys for the Alliance Defending Freedom have said the retractions should have no bearing on the case.
“ADF has never relied on these studies for the issues that are currently before the Supreme Court,” ADF Senior Counsel Erik Baptist told States Newsroom in a written statement. “So this will not have any impact on the court’s consideration.”
However, ADF cited the research frequently to make its claims that mifepristone is a risky drug. “The number of chemical abortion-related emergency room visits increased by over five hundred percent between 2002 and 2015,” reads an ADF primer on the case. “Women can face severe bleeding and life-threatening infections — requiring emergency medical treatment, surgeries, blood transfusions, and hysterectomies — as well as the inability to have future successful pregnancies.”
Kacsmaryk in turn cited the 2021 paper to argue plaintiffs’ standing “because they allege adverse events from chemical drugs can overwhelm the medical system.” He cited the 2022 paper using the same dataset in affirming plaintiffs’ claims that loosening FDA regulations has led to “‘many intense side effects’ and ‘significant complications requiring medical attention.’” The 2022 paper was cited just one day after the reactions in a brief filed by the intervening states.
The researchers themselves claim they have been influential.
“Sage is targeting us because we have been successful for a long period of time,” Studnicki says in his video uploaded to the Charlotte Lozier’s Assault on Science website. “These findings have been used in a legal action in many of the states. We have become visible. People are quoting us, and for that reason we are dangerous. And for that reason, they want to cancel our work.”
Comments are closed.