Research released Tuesday indicates Ohio patients received far fewer medication abortions, suffered more side effects, and paid more for the two-drug regime when doctors followed outdated U.S. Food and Drug Administration (FDA) labeling.
The new retrospective study in the journal PLOS Medicine found medication abortions plunged 80 percent following the passage of a 2011 Republican-backed Ohio law, which required providers to adhere to FDA guidelines from 2000.
Patients in the study were three times as likely to need additional treatment to end their pregnancies. Some patients needed another dose of medication because severe nausea caused them to throw up the first dosage.
“Women got out to the parking lot, and they were vomiting and they had to come back [to the clinic] and take the dosage again,” said Ushma Upadhyay, lead author of the paper and associate professor of obstetrics, gynecology, and reproductive sciences with the research group Advancing New Standards in Reproductive Health at the University of California (UC), San Francisco.
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The research is the first head-to-head comparison pitting evidence-based protocols for medication abortion against state mandates, Upadhyay told Rewire in a phone interview.
The team of researchers looked at the medical charts of 2,783 women who obtained medication abortions at four Ohio clinics. The women were early in pregnancy, and took the abortion-inducing pills no later than 49 days from their last menstruation. The study period, 2010 to 2014, spanned the years before and after the enactment of the Ohio law.
Upadhyay said the Ohio law was “unique” because it “so clearly defied” standards of care.
“I was curious to find out whether medication abortion would be as effective after this law,” Upadhyay said. “It was definitely less effective.”
Medication abortion calls for two drugs—mifepristone and misoprostol. The Ohio law requires doctors to administer three times as much mifepristone (600 mg vs. 200 mg) than advised by medical evidence. That higher, more expensive dose of mifepristone, plus a state-mandate requiring four office visits rather than three, drove up the cost of medication abortion 29 percent, to $551, the authors found.
The Ohio law also required doctors to administer less misoprostol, the drug that causes the uterus to contract and expel the pregnancy. As a result, Upadhyay said some patients experienced cramping insufficient to end a pregnancy.
“That lower dosage isn’t as effective,” Upadhyay said of Ohio’s requirements for misoprostol.
The rate of side effects almost doubled under the Ohio law, which passed through the GOP-majority legislature. Nearly 16 percent of patients experienced at least one side effect after the law was enacted, compared to 8.4 percent before the law.
As the authors note, it’s common and legal for doctors to prescribe medications “off label,” and research indicates that roughly 21 percent of drugs are prescribed for off-label use. Major medical groups, including the American College of Obstetricians and Gynecologists and the World Health Organization, back the evidence-based regime for medication abortion, as the authors note.
Even so, Republican lawmakers have championed legislation in states like Ohio, North Dakota, and Texas to force doctors to administer medication abortion contrary to medical best practices, which often evolve to accommodate new scientific research.
As the authors write,”There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite.”
“Abortion is a procedure that is so safe that it’s hard to substantiate needing a law to make it safer,” Upadhyay told Rewire.
The FDA in March updated medication abortion labeling to incorporate medical evidence, meaning the labeling now mirrors what the medical community regards as best practices. But medical science is not static, and Upadhyay said laws like Ohio’s force doctors to follow guidelines that may not keep up with the latest standards of care—to the detriment of pregnant people.
“My concern is Ohio women won’t be able to avail themselves of the most recent developments,” Upadhyay said. “Medication abortion has lots of potential for increasing access. Given that the [Ohio] law is still in place, women…will not be able to avail themselves of advancements in clinical research the way women in other states can.”