Ohio abortion pill restriction had no clear safety benefits, study finds

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Number and effectiveness of abortions by medication has plummeted since state limited use of mifepristone, with supporters citing health concerns

Abortion rights supporters demonstrate outside the US supreme court.
Abortion rights supporters demonstrate outside the US supreme court. Photograph: Alex Wong/Getty Images

A 2011 Ohio abortion restriction which supporters touted as a health measure had no perceptible benefits for women’s safety and drastically reduced the number and effectiveness of abortions by medication, according to a new study published in PLOS Medicine.

The study scrutinized the impact of requirements for abortion providers to strictly adhere to the Food and Drug Administration’s labelling for mifepristone, commonly known as the abortion pill. In recent years, several conservative states have enacted such requirements, citing women’s safety.

But mainstream medical groups say the evidence shows the FDA guidelines are outdated and recommend abortion providers prescribe the pills according to the latest evidence. The old regimen is more costly, less effective, and more cumbersome for patients. And abortion rights advocates have argued that laws like Ohio’s are thinly veiled attempts to limit an easy method of abortion.

Lending some credence to their arguments, the new study found that the number of women having abortions by using medication cratered after the law took effect.

In 2010, the year before the law was in place, 22% of all abortions in Ohio were medication abortions. In the three years after, only 5% were. The number of women obtaining medication abortions was so small, in fact, that it took Dr Ushma Upadhyay, the researcher who conducted the study, three years after the law took effect to collect a representative sample size.

The law can also be associated with “more visits, more side-effects, and higher costs for women compared to before the law”, the study said. After the new rules took effect, women using the abortion pill were three times more likely to need additional treatment – another dose of medication or a surgical procedure – to end their pregnancies.

Women reported experiencing more side-effects of the drugs, notably nausea or vomiting. And because the outdated drug regimen calls for a higher dose of one of the drugs, medication abortion cost women $125 more, on average.

At the same time, the study found, Ohio’s anti-abortion law wasn’t associated with safer abortions. “There is no evidence that the change in law led to improved abortion outcomes,” the author wrote. “Indeed, our findings suggest the opposite.”

“Retrospectively, you can see these laws were ridiculous,” said Beverly Winikoff, the president of Gynuity Health Projects, which researches ways to make the abortion pill more widely available. “These laws were paraded around as somehow being better for women when there was no and still is no evidence that the things this law did would have made abortion safer.”

“No matter how hard you look, you can’t find any benefit for women,” she continued. “Not for their health, not for their pocketbook, not for their convenience, nothing.”

Upadhyay, a researcher with a University of California – San Francisco program, Advancing New Standards in Reproductive Health, analyzed the medical charts of 2,783 women who obtained medication abortions at four Ohio abortion clinics between 2010 and 2014.

She expected to see some drop in the number of medication abortions, but not one this dramatic. “I wasn’t expecting a threefold increase in the proportion of women who required additional treatments,” said Upadhyay. “But there’s no other potential confounder that could have explained the difference.”

The FDA approved mifepristone for sale in 2000, with a label based on European prescribing practices from the 1980s. By the time the FDA approved the label, mainstream medical groups such as the American College of Obstetricians and Gynecologists already considered its instructions to be out of date. They encouraged abortion clinics to prescribe the pill off-label and according to the latest evidence, a practice which is legal and even encouraged by the FDA.

The modern prescribing guidelines called for a smaller dose of mifepristone and allowed women to take a second course of medication at home, saving them an extra trip to the doctor’s office. The evidence-based guidelines also allow the pill to be prescribed later in a pregnancy.

Ohio’s law is still in force, but early this year, its effects became moot. The FDA announced in March that it had approved a new label for the drug reflecting the modern prescribing guidelines. The change allowed Ohio abortion providers to resume prescribing the pill in the same way as before the law took effect.

The same was true for two other states, North Dakota and Texas, that had passed similar requirements. (Laws passed in Oklahoma, Arizona, and Arkansas are currently blocked in court.)

Some abortion patients have reported a preference for the abortion pill over the surgery because they feel the medication abortion is more private. Under the modern prescribing regimen, women can take their second doses of medication at home.

But Ohio’s law, said its critics, eliminated the benefits of the pill. Because a woman must take the second dose in the doctor’s office, the abortion is less private and potentially more unpleasant. One abortion provider reported that, after the law forced him to use the outdated regimen, some of his patients would begin bleeding not at home but in their cars as they left his office.

In Ohio, many abortion clinics stopped providing medication abortions once the law took effect, because the number of appointments required was so unwieldy. “It basically defeated the purpose of the medical abortion,” said Sue Postal, who formerly ran an abortion clinic in Toledo and stopped providing the pill due to the law.

In states pushing similar restrictions, abortion providers have threatened to stop providing the pill out of concern that the outdated regimen is not up to the standard of care.

Anti-abortion groups, in reaction to the study, repeated their assertions that the abortion pill is dangerous.

“A new study by abortion industry advocates released today should be met with the same skepticism we would give to tobacco industry findings that their products are ‘safe’,” said Clarke Forsythe, the senior counsel for Americans United for Life, which supports restrictions on medication abortions. (In the study, Upadhyay discloses the Susan Thompson Buffet Foundation as a source of funding and states that the foundation had no role in executing the study.)

“Chemical abortions can be very dangerous for women, and it’s appropriate for state officials to protect women’s lives with life-affirming legislation,” Forsythe said. He cited 2,207 cases of severe adverse events linked to mifepristone that the FDA reported in 2011.

Those cases, though, made up a fraction of women who took the pill. The number comes from an FDA a survey of 1.52 million women who had taken mifepristone which found that only 0.04% of cases had complications requiring hospitalization – although subsequent studies have argued that the FDA used a method that undercounted the number of complications.

Winikoff pointed out that even though the Ohio law is moot today, it still prevents Ohio abortion providers from updating their practices to reflect new evidence until the FDA approves another label for mifepristone.

Her group, Gynuity, which provided much of the evidence that prompted the FDA to update its labelling earlier this year, is currently studying the effectiveness of prescribing the pill beyond 10 weeks, and mailing the pill to women living in remote areas.

Gynuity’s study on prescribing the pill up to 11 weeks should be released by the end of the year. “Stay tuned,” Winikoff said. “It’s going to be interesting.”