When Ohio legislators passed a bill restricting how doctors could administer abortion pills 12 years ago, supporters said it would create a safer way to end a pregnancy.
The law, they said, would protect women from unscrupulous abortion providers who "passed these pills out like Skittles."
But the law made abortions more dangerous in Ohio, according to a new study, which says the statute's requirements increased complications and follow-up visits for women who took the drug to end their pregnancies.
The study, published in the online journal PLOS Medicine, looked at 1,156 Ohio abortions before the law went into effect and 1,627 afterward to determine if women had more complications or other negative outcomes.
House Bill 126 was signed into law in 2004 and spent seven years tied up in court battles before going into effect in 2011. It required abortion providers to adhere unswervingly to decade-old Food and Drug Administration recommendations when prescribing mifepristone. The pill is part of a duo used to induce what are called medication abortions. They're viewed as a safe alternative to more invasive, surgical abortions.
For women in Ohio, the abortion pill law meant going to a provider at least four times — an initial consultation followed by a mandatory 24-hour waiting period, two trips to administer pills and a final follow-up to make sure there were no complications, said Ushma Upadhyay, of the University of California at San Francisco, the lead researcher on the study. It also meant one standard dosage for all women, which could increase complications.
Complications meant more visits. Without the Ohio law, the number of visits could be halved, according to Upadhyay.
The law "meant a woman had to come back and get additional medical treatments, unnecessary medical treatments," Upadhyay said. "If a woman is not treated and she has an incomplete abortion, it could lead to an infection, it could lead to hemorrhage, additional bleeding. Probably at that point, she would have ended up in an ER."
The time and money costs were most prohibitive for the poor, the study said, because the state's Medicaid law doesn't typically cover abortions. Poor women, she said, were less likely to return for complications they couldn't afford to treat.
The FDA updated its recommendations earlier this year, which brought Ohio's requirements up to date, Upadhyay said. But the state will lag behind again whenever the greater scientific community makes an improvement in how to administer the drug.
Still, critics of the law said it chips away at abortion rights — and makes pregnant women in Ohio less safe in the process.
"Let’s dispel the notion that the antiabortion crew is out to make abortion safe; they're not," said Kelly Copeland, executive director of NARAL Pro-Choice Ohio. "Their single goal is to make it inaccessible. ... When they pass these regulations, it’s really about limiting access."
The Ohio law, experts say, prevents doctors from tailoring the medicine to individual patient needs or taking into account new studies or best practices for how the drug is prescribed.
Upadhyay, whose research focuses on the effects of women's empowerment and gender equity on reproductive health, pored over thousands of medical files from before and after the Ohio law took effect.
Among the findings:
- Negative side effects from mifepristone were more common after the law went into effect. (15.6 percent after the law, up from 8.4 percent).
- Women who had medication abortions after the law was passed had three times the odds of requiring an additional treatment.
- Before the law was passed, 4.9 percent of women required additional treatments. Afterward, that ratio jumped to 14.3 percent.
- There was an 80 percent decline in medication abortion in Ohio between 2010 and 2014 while non-medication abortions stayed constant over the same time period.
The law was written to keep Ohio women safe, said Ohio state Rep. Tom Brinkman Jr. (R), its sponsor. In 2002, when mifepristone was a new and not widely used, he said he read reports that women who had been prescribed the drug had died.
"There were reports ... and they reported people dying from it. ... A woman was just passing them out without instructions, without telling people what do to. They were dying because these pills were being handed out like candy."
Brinkman told The Washington Post he opposes abortion in all forms. He was a representative from 2001 until 2008, when term limits prevented him from running again. He was reelected in 2014. As a legislator, he's introduced several antiabortion bills, including an outright ban in 2006.
Brinkman's bill joined a parade of state laws across the country that sought to restrict abortions by requiring waiting periods, ultrasounds, counseling or stringent standards for abortion centers. In July, the Supreme Court struck down a Texas law that required abortion clinics to meet expensive hospital-like standards of surgical centers.
The Ohio law was one of several passed by state legislatures to restrict access to medication abortion.
Brinkman said his solution was to make providers adhere to FDA recommendations, which he called "the gold standard."
For Ohioans, he said, that was a better standard than medical research that could be inconclusive and contradictory.
"There’s a lot of debate in the [scientific] community over everything," he said. "Since 1930, Pluto was planet. About four or five years ago, Pluto’s not a planet anymore."
But Upadhyay said the FDA's recommendations were outdated by more than a decade when the Ohio law went into effect in 2011. Researchers had conducted more studies about the drug's efficacy, international medical organizations had determined better practices and doctors had determined better ways to use it, an accepted practice known as "off-label" use.
"After approval, clinical trials continue, and there are just the realities of everyday use," Upadhyay said. "Research just continues after the protocol was approved by the FDA."
Doctors found, for example, that mifepristone could safely be administered up to 10 weeks after a woman got pregnant instead of seven, Upadhyay said. The drug also can be administered at lower dosages for some patients, which would limit side effects.
"That's big," she said. "At seven weeks, a lot of women don’t even know they're pregnant if it's unintended. If you’re not planning for it, you’re not thinking of it."
In 2016, the FDA changed its guidelines, including the dose, the dosing regimen for taking these drugs. It also "modifies the gestational age up to which Mifeprex has been shown to be safe and effective, as well as the process for follow-up after administration of the drug," according to the agency.
NARAL Pro Choice Ohio's Copeland said she and Brinkman have been on opposite sides of the abortion debate for more than a decade.
"I have to say that when this study came out, there was a big part of me that was like, 'I told you so.' I told this legislature that women would pay a price for their political interference," Copeland said. "It’s not satisfying to be right when people are suffering. I do hope it would be a wake-up call for some of these legislatures, that you’re playing with people’s lives."