When Ohio legislators passed restrictions for abortion providers prescribing the “abortion pill,” they did so under the guise of protecting women’s health. But a new study in PLOS Medicine suggests that this justification was misleading, and even led to worse outcomes for patients in Ohio.
In 2004, Ohio legislators passed a law requiring abortion providers to prescribe the “abortion pill” mifepristone in accordance with the original FDA protocol, first approved in 2000. After a protracted legal battle, the law went into effect in February 2011.
Up to that point, Ohio abortion providers were able to prescribe mifepristone off-label—a common and legal medical practice in which more current, evidence-based standards are substituted for FDA guidelines. They could use lower doses of the drug and allow women to take the second medication in a medical abortion, misoprostol, at home rather than in the doctor’s office. Clinics were also able to offer medical, rather than surgical, abortion up to nine weeks from the start of a woman’s last period.
According to the PLOS Medicine study, which analyzed medical chart data from four abortion providers before and after the law, forcing Ohio abortion providers to adhere to the outdated FDA guidelines did not improve women’s health.
“There is no evidence that the change in [the Ohio] law led to improved abortion outcomes,” the study concludes. “Indeed, our findings suggest the opposite.”
After the 2004 mifepristone law went into effect in February 2011, the percentage of Ohio women who reported a side effect like nausea or vomiting from a medical abortion nearly doubled from 8.4 percent to 15.6 percent.
That wasn’t the only likely consequence of the law, either: After February 2011, Ohio women undergoing medical abortions not only had to pay a higher price for the larger dose of mifepristone, they also required more medical treatments and more follow-up visits than their pre-law predecessors.
“Despite legislators’ claims that this law was aimed at improving women’s health, our findings show the result was the opposite,” said lead author Dr. Ushma Upadhyay, an obstetrics and gynecology professor at UC San Francisco, in a press release. “The protocol required by law ignores the fact that medical practice is constantly improving as a result of clinical research.”The original law was passed based on the notion that it would protect Ohio women. In 2004, the bill’s sponsor, Rep. Tom Brinkman, claimed that banning the off-label use of mifepristone was in women’s best interest, telling the Cincinnati Enquirer a cautionary tale about an Akron resident who suffered a complication from a medical abortion.
A Planned Parenthood official assessed his intentions differently, saying, “I think we have legislators trying to practice medicine.”
Indeed, despite evidence from the American College of Obstetricians and Gynecologists supporting the off-label use of mifepristone and misoprostol, the Ohio law required abortion providers to follow a decade-old FDA protocol from February 2011 until March 2016, when the FDA finally updated the regimen.
A medical abortion is a regimen of two pills, mifepristone and misoprostol, taken in sequence about one to two days apart. The first pill blocks progesterone and the second induces an abortion. Barring complications, no surgery is required.
The FDA’s March 2016 update allowed Ohio abortion providers to once again prescribe lower doses of mifepristone and to allow women to take misoprostol at home instead of in the doctor’s office. The FDA also extended the timeframe for medical abortion to 10 weeks from the start of a patient’s last period.
“In essence, all of these differences [in the 2016 FDA regimen] mean a higher success rate, lower likelihood of requiring more treatments to complete the abortion, and fewer side effects,” Dr. Upadhyay told The Daily Beast.
According to the study, which was co-authored by researchers from Ohio State University and Planned Parenthood Federation of America, Ohio women likely could have been experiencing these benefits for the last five years.Instead, follow-up visits for medical abortion increased by 2 percent after February 2011, and the need for an additional intervention jumped from 4.9 percent to 14.3 percent. The average cost of a medical abortion also went up from $426 to $551.
On top of that, fewer Ohioans were able to choose medical abortion in the first place. In the four clinics tracked by the researchers, medical abortions accounted for 22 percent of all abortions performed before the law and only 5 percent after the law.
Much of that dramatic drop-off was due to the shortening of the window during which providers could legally offer medical abortion. But some of the decrease, Upadhyay says, can likely be attributed to the logistical hurdles created by the jarring return to the 2000 FDA protocol.
“While the law was in effect, women opting for medication abortions needed to make four separate trips to the provider, compared to two for an in-clinic aspiration abortion procedure,” he explained.
Even now that the FDA has updated its mifepristone protocol, there’s nothing to stop this pattern from repeating itself in Ohio while the law remains in place, the researchers say.
“Although the FDA has now updated the regimen for medication abortion to bring it in line with the current evidence, it, too, will eventually become out-of-date,” Upadhyay told The Daily Beast.
Clinical trials, he says, are currently testing pharmacy access for mifepristone and assessing the safety of medical abortion up to 77 days from the beginning of a woman’s last period. If these practices go into effect in other states in the coming years, Ohio women will once again receive less advanced medical care than their neighbors. According to the Guttmacher Institute, two other states—Texas and North Dakota—have similar legislation that is in effect, and they, too, would be left adhering to an aging FDA protocol.
“This study demonstrates that health care policy should always be based on scientific evidence,” said Upadhyay. “When health care policies are not evidence-based, they can lead to worse health outcomes for women.”
That’s a cautionary tale—with data to back it up.