New Study Affirms March FDA Ruling To Change Dosage Requirements For Medication Abortion

NPR: Updated Guidelines Invalidate Ohio Law And Allow Doctors To Follow What Has Been “Standard Practice For Administering [Medication Abortion] Drugs For Years.” In March 2016, the FDA updated its dosage guidelines for mifepristone and misoprostol -- two medications used to safely and effectively induce an abortion. As NPR’s Camila Domonoske explained, since the original guidelines were written, “doctors determined it was effective at lower doses and could be used later into a pregnancy.” NPR quoted Guttmacher Institute policy analyst Elizabeth Nash, who noted that this lower-dose regimen has become the legal and “standard practice for administering the drugs for years now.” Domonoske continued that Ohio was one of three states that “had passed laws saying doctors must follow the FDA label” even though it was “based on early trials of the drug and didn't reflect the changes in medical practice over the past 15 years.” As a result of the FDA’s new guidelines, Domonoske wrote, in states like Ohio, “the FDA’s new label will make the abortion-inducing drug[s] easier to get.” [NPR, 3/30/16]

LA Times: Study Found Ohio’s Restriction Forced Providers “To Follow The FDA’s Outdated Protocol” Rather Than Administer Care “Based On The Latest Research And Best Practices.” The Los Angeles Times highlighted a recent study that quantified the negative impacts of an Ohio law that “forced” providers “to follow the FDA’s outdated protocol” rather than use “the latest research and best practices.” The study evaluated “the medical records of 2,783 women who had medication abortions ... in Ohio between 2010 and 2014” and found that “women were nearly three times more likely to require additional intervention after the law was implemented than they were before.” From the Los Angeles Times:

The World Health Organization, the American Congress of Obstetricians and Gynecologists and the National Abortion Federation found shortcomings with the FDA’s protocol soon after it was issued, and began recommending changes as early as 2003. Healthcare providers throughout the U.S. followed their lead and prescribed the drugs according to the latest medical research rather than the dosages on the drug’s label.

The practice of prescribing drugs for use “off label” is both legal and commonplace. By one estimate, 21% of all U.S. prescriptions are intended for off-label use.

Before Ohio’s law went into effect, doctors in the state were able to decide what doses of the drugs were most effective based on the latest research and best practices. Afterward, doctors lost that flexibility and were forced to follow the FDA’s outdated protocol.

To see what effect that had on patients, researchers examined the medical records of 2,783 women who had medication abortions at one of four clinics in Ohio between 2010 and 2014.

The researchers found that women were nearly three times more likely to require additional intervention after the law was implemented than they were before. [Los Angeles Times, 8/30/16]

Media Highlight Findings That Ohio’s Restrictions On Non-Surgical Abortion Ran Counter To Best Medical Practice

NY Times Editorial Board: Medical Abortion Is Safe, But Restrictions Like Ohio’s Aren’t “Based In Science” And The “Best Way To Protect Women’s Health Would Be To Repeal Them.” In a September 2 editorial, The New York Times criticized anti-choice restrictions on non-surgical abortion because “none of these laws are based in science.” The editorial board wrote that restrictions like Ohio’s “make the process more onerous” to access non-surgical abortion and can even force doctors to prescribe the medications in ways “that could even harm women’s health.” According to the Times, contrary to anti-choice politicians’ justification that such laws are meant to improve the safety of abortion procedures, “The best way to protect women’s health would be to repeal them.” From The New York Times:

Since 2000, over a million American women have been able to terminate pregnancies safely using drugs instead of surgery. Over the years, doctors have found ways to make these sorts of abortions even safer and more convenient, but anti-choice politicians in many states have pushed restrictions that make the process more onerous and that could even harm women’s health.

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[S]tarting in 2011, Ohio barred doctors in the state from prescribing mifepristone other than as part of the F.D.A.’s approved regimen. Proponents of the law, one of more than a dozen abortion restrictions that have taken effect in the state over the past five years, claimed that it would protect women’s health and safety.

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Similar laws are in effect in North Dakota and Texas. At least three dozen states require that abortion medication be provided by licensed physicians, although the World Health Organization has determined that physician assistants and advanced practical nurses can safely offer the medication. And while programs in several states allow doctors to prescribe abortion medication without an office visit, so that women who live far from a doctor’s office can get the drugs at a clinic or health center, 19 states require that a doctor be present to prescribe the drugs.

None of these laws are based in science. The best way to protect women’s health would be to repeal them. [The New York Times, 9/2/16]

Mother Jones: “The Sad Irony” Of Ohio’s Anti-Choice Dosage Restriction Was That It “Actually Harmed Women Who Were Forced To Comply.” Building on previous reporting about the FDA’s updated dosage rules, Mother Jones’ Becca Andrews wrote that “the sad irony” of Ohio’s anti-choice restriction was that it “actually harmed women who were forced to comply.” In the August 30 article, Andrews noted that researchers from Advancing New Standards in Reproductive Health at the University of California-San Francisco, which conducted the study, found “an 80 percent decline in medication abortion between 2010 and 2014” in Ohio due to the burdensome requirement. Similarly, researchers found that women who did obtain a medication abortion “were more likely to have to revisit their physician after the restrictions were in place” either to acquire “additional treatment,” extra doses, or in some cases “an aspiration abortion.” Lisa Keder, a study co-author, told Mother Jones that these findings demonstrated that "‘Laws like Ohio's limit physicians from practicing medicine based on the latest evidence and providing the highest quality of reproductive health care to women.’” From Mother Jones:

The sad irony is that the laws have actually harmed women who were forced to comply.

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The ANSIRH researchers analyzed charts from four different Ohio abortion clinics for eight months to see if the state's law had affected the number of women receiving medication abortion and whether the outdated dosage caused negative health effects. It did: Ohio saw an 80 percent decline in medication abortion between 2010 and 2014, and the overall proportion of medication abortion compared with other methods also fell from 22 percent before the law to 5 percent in 2014. In comparison, most states that did not have such legislation saw a rise in medication abortion.

Ohio women also were more likely to have to revisit their physician after the restrictions were in place: After a patient took the post-law dosage, she required additional treatment, either another dose of mifepristone or an aspiration abortion. The percentage of women who received a medication abortion and needed an extra dose or an aspiration rose from 4.9 percent to 14.3 percent after the law went into effect. The rate of incomplete or possibly incomplete abortions also increased from 1.1 percent before the law to 3.2 percent after it. After the law, there was also a 48 percent increase in women who also required two or more follow-up visits after taking the pill.

“Laws like Ohio's limit physicians from practicing medicine based on the latest evidence and providing the highest quality of reproductive health care to women,” said study co-author Lisa Keder, associate professor of obstetrics and gynecology at Ohio State University. [Mother Jones, 8/30/16]

The Daily Beast: “Justification” Behind Anti-Choice Restriction “Was Misleading, And Even Led To Worse Outcomes For Patients In Ohio.” According to The Daily Beast’s Samantha Allen, although anti-choice legislators passed abortion pill dosage restrictions “under the guise of protecting women’s health,” the actual “justification was misleading, and even led to worse outcomes for patients in Ohio.” In her August 30 article, Allen explained that beyond making abortion harder to access, “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 follow-up visits” than women given the dosage prefered by abortion providers. Allen quoted the Ohio study’s lead author, Ushma Upadhyay, who noted, “‘Despite legislators’ claims that this law was aimed at improving women’s health, our findings show the result was the opposite.’” From The Daily Beast:

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.

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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 Daily Beast, 8/30/16]

The Guardian: Recent Study Found That Ohio’s Anti-Choice Law “Had No Perceptible Benefits For Women’s Safety.” The Guardian’s Molly Redden reported that although anti-choice politicians “touted [the restriction] as a health measure,” in reality, the medically unnecessary requirement “had no perceptible benefits for women’s safety.” Redden wrote that according to pro-choice advocates, “laws like Ohio’s are thinly veiled attempts to limit an easy method of abortion” -- an argument borne out by the results of the Ohio study. As Gynuity Health Project president Beverly Winikoff explained: “‘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.’” From The Guardian:

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 [Public Library of Science Journal] Medicine.

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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.” [The Guardian, 8/30/16]

NBC News: Abortion Wasn’t More “Dangerous For Women … But It Was A Lot More Burdensome” Due To Restrictions. In an article for NBCNews.com, Irin Carmon wrote that although the Ohio law may have sounded like “a simple, innocuous safety regulation,” the recent study demonstrated that “the effect of the law in one state, Ohio, was to actually increase the number of complications women getting abortions experienced.” Carmon characterized the Ohio restriction as straight “from the playbook of anti-abortion activists” before detailing the study’s findings about the law’s negative effects. As the study’s lead author, Ushma Upadhyay noted, the restriction didn’t make make the safe abortion procedure more “dangerous for women” but rather made the process “a lot more burdensome” as patients were forced “to go through additional treatments for their course of care.” From NBCNews.com:

It sounded like a simple, innocuous safety regulation: Doctors administering medication to end a pregnancy would have adhere to a protocol set by the federal Food and Drug Administration.

But according to a new study, the effect of the law in one state, Ohio, was to actually increase the number of complications women getting abortions experienced.

Ohio passed the medication abortion law in 2004 — it was among a half dozen similar ones nationwide and came from the playbook of anti-abortion activists.

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“It is ironic because it was passed with the stated intention of protecting women's health. Our evidence showed that women's health was really compromised because of this law,” said the study's lead author, Ushma Upadhyay, in an interview.

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“I'm not saying abortion was dangerous for women who got abortions after the law was enacted,” said Upadhyay. “But it was a lot more burdensome. They had to go through additional treatments for their course of care.” [NBCNews.com, 8/31/16]