Abortion restrictions implemented in Ohio in 2011 under the guise of protecting women’s health led to more side-effects and follow-up visits for patients, according to a new study out of the University of California, San Francisco.
The 2011 Ohio law makes sense on paper: it requires abortion providers to prescribe the abortion medication mifepristone (also known as RU-486) in compliance with federally approved guidelines. But those FDA guidelines had been last updated in 2000, which meant that providers were legally required to prescribe abortion medication according to protocols that were more than a decade old, even though evidence-based medical consensus suggested that a slightly different regimen might be safer, easier and more effective.
The Ohio law required doctors to adhere to recommendations present on the original drug label—the dose of the drug was considerably higher when the pill was first introduced, and the period of time for which is it thought to be safe to take has grown since the late 1990s—even though that guidance was based on outdated medical research.
In March of 2016 the Food and Drug Administration (FDA) updated its guidelines to bring its mifepristone recommendations in line with current evidence. But between 2011 and 2016, Ohio abortion providers were legally required to prescribe the abortion medication in a regimen that was out-of-step with the latest science.
“On the face of it, it sounds reasonable to require providers to use FDA protocol,” says Dr. Ushma Upadhyay, a professor of obstetrics and gynecology at UCSF and lead author of the study. “But it’s an inferior protocol.”
That led to worse outcomes for the patients. The UCSF study of more than 2,700 Ohio patients, published Tuesday in the journal PLOS Medicine, found that between 2011 and 2016, Ohio women who had medical abortions were almost three times more likely to require additional medical treatment than they had been before the law was passed (before the law was passed, only 5% of medical abortions required additional treatment, but after the 2011 law more than 14% of medical abortions resulted in a follow-up visit). Patients also reported higher logistical burdens (the law required patients to make four visits instead of two) and increased rates of side effects like nausea and vomiting, likely due to the higher dose of the drug.
The law also seems to have correlated to an 80% decline in medical abortions, which is troubling because medical abortions (which are done with medication in the early stages of a pregnancy) are widely considered to be cheaper and less invasive than surgical abortions. Before the 2011 law, 22% of Ohio abortions were medical abortions, but by 2014 only 5% of all Ohio abortions were medical abortions.
The study comes just two months after the Supreme Court struck down a Texas abortion law that would have closed more than half the state’s abortion clinics, ruling that the restrictions—which were presented as regulations to protect women’s health—constituted an “undue burden” on the constitutional right to an abortion. In his majority opinion, Justice Stephen Breyer wrote that there was not enough “medical benefit” to justify the restrictions.
Dr. Upadhyay says she knows of no other state law that outlaws or requires providers to use a specific federal regimen. Usually doctors are free to prescribe treatment according to the latest clinical research and evolving best practices, not slow-moving federal guidelines. “This medication was singled out,” she says.
The FDA updated its guidelines for mifepristone usage in early 2016, bringing them in line with current medical practice—that meant reducing the dosage, decreasing the number of required follow-up visits, and extending the period of time during which it can be used—but the restrictive laws still require doctors to follow the FDA guidelines, not the latest science. And if research outstrips the FDA guidelines again, doctors will have their hands tied.
“There’s no way a federal agency could dictate how a specific medication regimen should go for all patients,” says Dr. Upadhyay. “When a law doesn’t follow the evidence, and doesn’t respect the doctor-patient relationship, I think it causes problems.”
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