Study cited by Texas judge in abortion-pill case under investigation

Pharmaceutical sciences professor Chris Adkins was perusing news on his computer in December when he came across an item that fascinated him: Anti-abortion groups had sued the U.S. Food and Drug Administration to force a recall on a commonly used abortion drug.

Adkins teaches future pharmacists at South University School of Pharmacy* in Savannah, Georgia. His early career research focused on cancer drugs, but mifepristone is among the many drugs he’s familiar with. Adkins understood from the medical literature that the FDA-approved two-drug abortion regimen has a high safety and efficacy record. So it surprised him to read plaintiffs arguing this medication is so unsafe it needs to be pulled from the market. But what he still can’t get over is the research U.S. District Judge Matthew Kacsmaryk cited liberally to order a suspension of mifepristone’s FDA approval earlier this year.

That ultimately blocked April 7 ruling in Alliance for Hippocratic Medicine v. FDA relied on a handful of studies authored by many of the same anti-abortion activists directly involved in suing the FDA. 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.

“Here, the (plaintiff medical) associations’ members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place ‘enormous pressure and stress’ on doctors during emergencies and complications,” Kacsmaryk wrote.

But U.S.-based global academic publisher Sage Publishing, which publishes thousands of journals, including “Health Services Research and Managerial Epidemiology,” is now investigating this study and the peer review process it went through after Adkins contacted the journal in April with a pile of red flags. Last week Sage published an “expression of concern” about the paper.

“As part of the investigation, we are looking into Dr. Adkins’ concerns as well as any concerns related to conflict of interest,” Sage spokesperson Camille Gamboa told States Newsroom in an email.

The lead author of the paper, James Studnicki, who works for the anti-abortion think tank Charlotte Lozier Institute, is also on the editorial board of “Health Services Research and Managerial Epidemiology.” Gamboa said Studnicki, in accordance with his journal’s ethics guidelines, was “not involved in the decision-making process for this article.”

Adkins dissected this paper the way he used to as a onetime peer reviewer. He told States Newsroom the authors exaggerated their findings and visually misrepresented them in ways that are “grossly misleading.” And that’s led to legal consequences. Except, he said, their study doesn’t actually show what Kacsmaryk said it does: that medication abortion leads to significantly high rates of complications.

“I can’t prove that there was intent to deceive, but I struggled to find an alternative reason to present your data in such a way that exaggerates the magnitude,” Adkins said. “They’re misrepresenting its conclusions to begin with. That’s my frustration with this whole process.”

For now, mifepristone remains legal (except in the 14 states with total abortion bans). But this high-stakes federal lawsuit is ongoing, awaiting a decision from the conservative 5th U.S. Circuit Court of Appeals. And while Sage determines whether this study should have been published in the first place, plaintiffs continue wielding it as one of their best defenses against a safe drug protocol that is now the most common method of terminating a pregnancy (and managing miscarriages) post-Roe v. Wade.

Wading into politically charged science fights is new territory for Adkins. So is advocating for abortion rights, something he says he didn’t believe in when he was growing up in Amarillo, Texas, where the lawsuit was coincidentally filed. He said his views on abortion (and gender and climate science) radically shifted when he left his conservative hometown for graduate school and then became a scientist.

“I have significant concerns about the merits, legality, and use of shoddy studies and personal anecdotes to upend national healthcare policies essential to women’s reproductive health and bodily autonomy,” Adkins told States Newsroom. “To go out and say this drug needs to be, you know, removed from the market, it’s not honestly paying tribute to what the true science really is saying.”

Roe v. Wade was overturned on Adkins’ birthday last year — about a year before he would meet his first child. Living in South Carolina, where laws about pregnancy termination have toggled throughout the year, Adkins has been thinking often about the consequences of ending federal abortion rights. He’s grateful his wife didn’t have any pregnancy complications, but he worries about her reproductive freedom going forward, and that of their weeks-old daughter.

“I now have a daughter that is born in a world where there is no Roe v. Wade, no federal recognition that women have the right of bodily autonomy,” Adkins said. “And just, I don’t know. … I’m going to support her in whatever way I can.”

Studnicki et al.

This lawsuit ultimately hinges on scientific questions: Was the science strong enough to justify the FDA’s approval of abortion drugs more than 20 years ago and then its relaxing of certain restrictions? And does the data predominantly show that medication abortion is safe and effective? Evidence in the affirmative, presented by the FDA’s defense team, outweighs that of plaintiffs in volume and medical journal prestige.

Most drugs approved by the FDA come with some risk of side effects, but mifepristone’s risk level is significantly lower than many commonly used over-the-counter drugs. In 23 years, 28 out of more than 5 million medication-abortion patients have died, but not all necessarily because of mifepristone. Some died of sepsis, ectopic pregnancies, homicide and drug overdoses.

Still, plaintiffs who sued the FDA to revoke mifepristone’s approval rely on studies that have been criticized — and on speculation about a potential spike in future adverse events.

Many U.S. scientists and mainstream national medical institutions like the American Medical Association have asked the courts not to overturn FDA approval of mifepristone, and have called out the misuse of science in the lawsuit. And yet, the conservative federal judges assigned to the case have been nodding along to plaintiffs’ hyperbolic arguments that abortion via medication leads to overwhelmed emergency rooms and blood supply shortages.

One study that appears to have convinced Kacsmaryk that mifepristone causes high amounts of severe adverse events was authored by a half-dozen longtime anti-abortion activists. The study, “A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015,” was funded by the Charlotte Lozier Institute, the research arm of the influential Susan B. Anthony Pro-Life America, which works to elect federal and state anti-abortion lawmakers. The study was published in November 2021, exactly one year before plaintiffs filed in the Amarillo court. Charlotte Lozier filed a “friend of the court brief,” citing its research.

All but one of the eight authors are affiliated with the Charlotte Lozier Institute, including principal author James Studnicki, who is the institute’s vice president and director of data analytics. Currently everyone on the editorial board of “Health Services Research and Managerial Epidemiology” works for a university except for Studnicki, who until 2016 was a university professor focused on health policy and management for most of his career. Now he works for an anti-abortion think tank and in recent years has served as a paid expert witness that defends anti-abortion laws in federal court.

Donna Harrison, another co-author, was until recently the CEO of the American Association of Pro-Life Obstetricians and Gynecologists, one of the plaintiff medical groups suing the FDA over mifepristone. Another author is longtime anti-abortion activist David Reardon, who has a record of criticized research that tries to directly link abortion to depression and suicide.

The Studnicki et al. 2021 longitudinal study looked at people who had a surgical or medication abortion between 1999 and 2015. The researchers used data from 17 states that allow state Medicaid funding of abortion, and identified more than 400,000 abortion patients. Of those they found that more than one-quarter visited an emergency department within 30 days of having the abortion. Over the 16 years, they found that there were progressively more emergency room visits following a medication abortion than a surgical procedure. The authors claim that between 2002 and 2015, there was a 500% increase in emergency room visits from people who had had a medication abortion within 30 days.

Following the study’s release in 2021, Studnicki penned an opinion piece in Newsweek, calling the study’s findings “clear and alarming.” “Post-abortion emergency room visits are increasing following any type of abortion, but visits following a chemical abortion are growing faster,” Studnicki wrote.

But Adkins and other researchers told States Newsroom that some of these findings are missing important context, and that the study’s major flaws are related to methodology and in how they communicate their findings:

• The study captures emergency room visits broadly and does not distinguish between routine medical care and adverse events. The codes they use lump in issues like ectopic and molar pregnancies, which are medical emergencies not necessarily related to having taken abortion drugs. University of California San Francisco reproductive health researcher Ushma Upadhyay led a similar study in 2015 and found that less than 1% of medication abortion patients have major complications. Upadhyay told States Newsroom that just looking broadly at emergency department visits among people on Medicaid does not give the most accurate picture of the abortion drug protocol’s safety, as many of the visits are observation-only. A medication abortion is an induced miscarriage and necessarily involves bleeding. First-time medication abortion patients often go to the ER because they don’t know what is normal. And that’s especially true if they don’t have a regular medical provider, like many people on Medicaid, Upadhyay said.

• Adkins said the study’s findings appear in line with increased use of the FDA’s medication abortion protocol between its approval in 2000 and 2015. The amount of patients on Medicaid also grew toward the end of that time frame, reflecting Medicaid expansion following the Affordable Care Act in 2014. “What they find is exactly what you would expect to find when you expand coverage and expand care,” Adkins told States Newsroom. “And so, you know, that really made me wonder, what degree of scrutiny was provided during the peer review process?”

• The researchers do not offer an estimated total of emergency department visits among Medicaid patients to contextualize the estimated abortion-related visits. “Nowhere in the article do the authors provide estimates of the total number of ER visits during 2015 among Medicaid patients in these 17 states,” Johns Hopkins Bloomberg School of Public Health professor Suzanne Bell told State Newsroom in an email. “I imagine the 790 ER visits they identified as associated with a recent medication abortion is a very small percentage of the total number of ER visits and in no way would risk overwhelming the medical system as Judge Kascmaryk suggests.”

Studnicki did not respond to a request for comment. He continues to defend the study, and recently told the Washington Post that abortion rights groups are discounting ER visits as serious matters and underplaying potential complications from abortions involving mifepristone. He blames academic and media bias for the criticism the Charlotte Lozier Institute’s work has received.

“We have a very biased media,” Studnicki said on the Canadian podcast Pro-Life Guys earlier this year. “Our media outlets are largely pro-abortion in their ideological posture. And we fight against that every day. But we’re just going to keep pounding on the rock basically.”

Adkins argues there is bias within Charlotte Lozier’s science and within the conservative courts hearing the Alliance for Hippocratic Medicine v. FDA lawsuit. Federal Judge Kacsmaryk used this paper (and a follow-up 2022 analysis published in the same journal, by the same researchers) to argue that mifepristone leads to high complication rates. This summer the Charlotte Lozier team produced yet another study using Medicaid data, this time published in the International Journal of Women’s Health, which concludes that a first pregnancy abortion compared with birth is associated with “significantly higher subsequent mental health services utilization.”

“The fact that, you know, the judge really gives a lot of credit to a very niche, a very small pocket of doctors that don’t fully represent consensus, that’s one of my big problems,” Adkins said.

In his April 7 ruling, Kacsmaryk also echoed plaintiffs’ arguments that the FDA has been undercounting adverse events related to mifepristone and cited the other big finding in the Studnicki paper, which is that some patients who have taken abortion drugs but come to the emergency room for observation or treatment are miscoded as miscarriage patients.

“Consequently, the treating physician may not know the adverse event is due to mifepristone,” Kacsmaryk wrote. “Studies support this conclusion by finding over sixty percent of women and girls’ emergency room visits after chemical abortions are miscoded as ‘miscarriages’ rather than adverse effects to mifepristone. Simply put, FDA’s data are incomplete and potentially misleading, as are the statistics touted by mifepristone advocates.”

The 5th Circuit Court of Appeals in its ultimately blocked April ruling to temporarily reinstate old restrictions on medication abortion, referenced many of the same studies as Kascmaryk to justify the plaintiff doctors’ position, writing: “the risk of severe bleeding with chemical abortion is five times higher than from surgical abortion.”

Adkins said he believes that how the Charlotte Lozier team presented their data visually lends for judges to be misled about the significance of the paper’s findings. For example, Figure 3 showed about 800 emergency room visits in 2015 within 30 days of a medication abortion, out of more than 5,000 abortion-related visits, but the authors inexplicably used two different y axes to plot these numbers, making it possible to conclude that medication-abortion-related visits were numbered in the thousands.

“Scientific communication is something I deeply value, and I think this is an example of one way that misuse of science through improper communication can influence how public policy manifests itself, through a result of dishonest science,” Adkins said. “It really makes the likelihood of someone misreading that and then, for instance, Kacsmaryk coming back and saying the alleged adverse events from chemical abortion drugs can overwhelm the medical system. Well, maybe he didn’t scrutinize these figures if he read this paper. That’s a highly plausible outcome here because he’s basically thinking, ‘Oh, my gosh, look at these numbers. They’re skyrocketing.’ When they’re really kind of not.”

For now, Adkins impatiently awaits the results of Sage’s probe into this study. A few months ago, he wrote a letter to Georgia U.S. Rep. Earl L. “Buddy” Carter, one of the few licensed pharmacists in Congress, who joined other Republicans in supporting the plaintiffs’ lawsuit against the FDA. Carter is outspokenly anti-abortion, but Adkins tried to appeal to the congressman’s inner pharmacist.

“All practicing US pharmacists publicly recite an oath which affirms pharmacists’ embracement and advocacy for ‘changes that improve patient care,’” Adkins wrote in the letter, which he says the congressman never answered. “The case rendered in Amarillo only deteriorates patient care and sows unnecessary distrust of scientific and medical institutions in the United States.”

*Chris Adkins said his opinions are his own and do not reflect the opinions or positions of South University.