After an Ohio law required doctors to follow an outdated Food and Drug Administration (FDA) protocol when prescribing drugs for medication abortions, women in the state experienced a higher rate of complications, according to a study published this week in the journal PLOS Medicine.
The law, which had been championed by anti-abortion activists, went into effect in 2011 after a protracted legal battle. Several other states have passed similar laws, although, because of court rulings, only Ohio, North Dakota and Texas ever got to implement them.
Proponents of such laws claim they are needed to protect women’s health and safety. But the new study found the Ohio law led to worse, not better, health outcomes for women. After the law passed, the percentage of women who needed additional medical treatment after having a medication abortion tripled.
Many more women ended up having to go to a clinic to complete the abortion — the very procedure they had been trying to avoid.
“There is no evidence that the change in [the Ohio] law led to improved abortion outcomes,” the authors of the new study conclude. “Indeed, our findings suggest the opposite.”
Needing update from the start
Before we get to the study’s details, here’s some background:
In 2000, the FDA set a protocol for doctors to follow when administering medications to end pregnancy. Under this protocol, two pills were prescribed: mifepristone and then, two days later, misoprostol. Both pills had to be taken at a doctor’s office and within seven weeks of a woman’s last menstrual period.
The FDA protocol was considered outdated almost as soon as it was announced, if not before. A string of clinical trials had already begun to show that there was a safer method of administering the drugs. It involved a lower dose of mifepristone and a higher dose of misoprostol. More important, women could take the second drug at home. Furthermore, the medication abortion could take place up to nine (and later ten) weeks of pregnancy.
The procedure thus became easier and less expensive. Its effectiveness rate also rose, from 88 percent to 92 percent (the rate of the FDA’s 2000 protocol) to 95 percent to 99 percent (the rate of the revised protocol).
Several international organizations, including the World Health Organization and the American College of Obstetricians and Gynecologists, issued guidelines recommending that the revised protocol be used.
Even though the FDA had not yet approved the revised regimen, U.S. doctors became persuaded by the scientific evidence and began to follow it (a practice known as prescribing “off label”) when their patients wanted medication abortions.
The FDA’s approval finally came earlier this year. In March, the agency updated its protocol for medication abortions to bring it into line with the current, widely accepted standard of care. Doctors in Ohio — and North Dakota and Texas — are now legally able follow the evidence-based regimen.
For the current study, a team of researchers led by Ushma Upadhyay, an associate professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, decided to examine the before-and-after effects on women’s health of the 2011 Ohio law.
They gathered medical chart data from more than 2,783 women who had obtained a medication abortion in Ohio between 2010 and 2014. Those women included 1,156 who had an abortion before the law passed and 1,627 who had one afterward.
The researchers then examined that data to determine the “before and after” proportion of women who received an additional medical intervention to complete the abortion, such as a repeat does of misoprostol or suction aspiration. They also looked at (among other things) the number of follow-up visits the women needed and whether or not they experienced side effects.
The analysis found that 14.3 percent of the women in the post-law period required an additional intervention compared to 4.9 percent in the pre-law period — almost a threefold increase. The proportion of women who needed an additional dose of misoprostol rose, for example, from 2.8 percent to 9.6 percent, while those who needed an aspiration procedure jumped from 1.3 percent to 2.9 percent.
Women in the post-law period were also almost twice as likely to experience side effects, particularly nausea or vomiting. Upadhyay and her colleagues attribute that finding to the higher dose of mifepristone required by the outdated protocol.
The data also showed that the incidence rate of medication abortions at the four clinics fell precipitously after the law was passed, from 22 percent in 2010 to about 5 percent in 2014. Upadhyay and her colleagues link that decline — which is the opposite of national abortion trends — to women having a more difficult time meeting the requirements (and the cost) of a protocol that requires a minimum of four trips to a doctor’s office.
“More than 10% of the patients in our sample travelled over 50 [miles] to get to the abortion provider,” write Upadhyaya and her colleagues. “[F]or women having to make four visits, this adds up to more than 400 [miles] traveled. The requirement of misoprostol administration in the provider’s office also led to cases of vomiting and other side effects beginning on the journey home.”
‘Women pay the price’
Like all studies, this one has limitations. For example, the study had no control group — one that was not exposed to the law. Also, many women did not return to their doctor for a follow-up visit, so if they did experience any side effects, those problems would not have been recorded.
Still, the findings are robust enough to serve as a public health warning.
As Upadhyaya notes in a commentary published Tuesday in the New York Times, laws like the one passed in Ohio “are not just covers for restricting abortion access — they can actually harm women’s health.”
“Claims that abortion laws will protect women’s health and safety are just that — claims,” she adds. “We need scientific research that evaluates these laws’ actual effects on women and their health. If state legislatures want to create policies around abortion, they should be based on evidence. When policy is not based on science, American women pay the price.”