Mon, March 25, 2024
Dr. Beverly Winikoff, President of the research group
By Andrew Chung
(Reuters) - The abortion opponents who are seeking to convince the U.S. Supreme Court to limit access to the abortion pill mifepristone point to three studies by Gynuity Health Projects, a New York-based women's health research group, to back up their arguments that it is unsafe despite its regulatory approval decades ago.
But the way the research has been prominently cited by the plaintiffs in their bid to limit how the pill is prescribed and distributed is bewildering to Dr. Beverly Winikoff, Gynuity's president, given that the conclusions broadly support easier access to the medication.
"They live on a different planet," Winikoff said of the plaintiffs during an interview at her Midtown Manhattan office. "You can always distort information and say things that aren't true."
The Supreme Court, whose conservative majority in 2022 overturned the landmark 1973 Roe v. Wade ruling that had recognized a constitutional right to abortion, is set to hear arguments in the case on Tuesday.
President Joe Biden's administration is appealing a lower court's decision that would roll back U.S. Food and Drug Administration actions in 2016 and 2021 to ease access to mifepristone. A ruling in favor of the plaintiffs could undercut federal regulatory authority over drug safety beyond just this medication.
The plaintiffs defend how they presented the research findings.
"We simply took the FDA's characterizations of these studies and presented them to the court," said Erik Baptist, a lawyer at the Alliance Defending Freedom conservative religious rights group representing the plaintiffs.
Mifepristone is taken with another drug called misoprostol to perform medication abortions, which account for more than 60% of U.S. abortions.
ABORTION CRACKDOWN
A series of Republican-backed abortion bans of varying strictness have been enacted by states since the 2022 Supreme Court ruling. Some states also impose their own restrictions on medication abortion.
The plaintiffs in the Supreme Court case are a group of medical associations and four doctors who oppose abortion on religious and moral grounds. To them, the FDA's decisions to relax mifepristone restrictions unlawfully placed women at risk.
The regulatory changes included allowing for medication abortions at up to 10 weeks of pregnancy instead of seven, and for mail delivery of the drug without a woman first seeing a clinician in-person.
The FDA gave mifepristone regulatory approval in 2000. It has said that after decades of use by millions of women in the United States and around the world, mifepristone has proven "extremely safe," and that "study after study" has shown that "serious adverse events are exceedingly rare."
The plaintiffs question the FDA's judgment, in part by pointing the Supreme Court in their written filings to the three studies published by Gynuity researchers in 2019 and 2021 as part of a project called TelAbortion, which evaluated the feasibility and safety of providing abortion drugs via videoconference and mail.
The FDA considered those studies, among others, in eliminating in-person visits.
The studies, the plaintiffs told the justices, show "troubling rates of emergency-room visits, urgent care trips, and unplanned medical encounters" and "increased risk" for patients.
But the studies report that "serious adverse events" such as hospitalizations or blood transfusions are rare. One of them specified that none of the 0.9% of serious outcomes would have been avoided with in-person screening.
Winikoff, who has studied medication abortion for more than three decades, said using emergency room or urgent care trips as a proxy for danger paints a false narrative, as most of these visits are not for serious medical emergencies, despite where they take place.
"You're counting apples and oranges," Winikoff said, adding: "This whole thing is misleading the public."
EMERGENCY ROOM VISITS
Dr. Daniel Grossman, director of the Advancing New Standards in Reproductive Health research group at the University of California San Francisco, said patients who use telemedicine to obtain medication abortion may live far from the prescribing clinician.
"So it's not surprising that if they have a question or concern they may go to an emergency department as many people in America do for much of their urgent healthcare," Grossman said.
Often that care is for "patients who just have a question or concern and they don't end up needing any treatment" as even more recent studies have found, Grossman said.
Baptist, representing the plaintiffs, pointed to the FDA's characterizations of the studies at issue.
"The FDA's own label considers emergency room visits to be 'serious adverse reactions,'" Baptist said.
"The studies that FDA cited in 2021 show that the risk of these emergency room trips will increase without the initial in-person visit. That should've caused the FDA concern. Instead, it pressed forward with its changes, compromising the health and safety of women," Baptist added.
The fight over the science behind mifepristone's safety escalated in recent weeks when prominent academic journal publisher Sage retracted three studies led by researchers at the Virginia-based anti-abortion Charlotte Lozier Institute, noting problems with methodology.
The plaintiffs, including the Alliance for Hippocratic Medicine, had cited two of the studies, including one reporting more emergency room visits following medication abortion compared to surgical abortion, in their 2022 lawsuit challenging FDA approval of mifepristone.
Texas-based U.S. District Judge Matthew Kacsmaryk also cited the studies in his 2023 decision siding with the plaintiffs.
"We don't need those studies to win," Baptist said. "All we need to prevail is what the FDA itself has said and the studies it has cited."
James Studnicki, director of data analytics at the Charlotte Lozier Institute and lead author of the retracted studies, said, "There is no legitimate reason for Sage's retractions." The institute told the Supreme Court in a filing that the retractions were made for "ideological" reasons even as the FDA relied on studies by "pro-abortion" researchers.
The New Orleans-based 5th U.S. Circuit Court of Appeals last year partially upheld Kacsmaryk's decision, faulting the FDA's loosened restrictions on mifepristone in 2016 and 2021. The 5th Circuit's decision remains on hold pending the Supreme Court's review. A ruling is expected by the end of June.
For Winikoff, no matter the outcome at the Supreme Court, medication abortion is here to stay.
"People really know what they need, and now they found something that's helpful for them and it fits into their lives better," Winikoff said. "I don't think that the women of America are going to give this up because some people don't like abortion."
(Reporting by Andrew Chung in New York; Editing by Will Dunham)
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