New York, NY – A new study published in PLOS Medicine from researchers at the University of California, San Francisco (UCSF), and Planned Parenthood reveals the significant obstacles and increased medical treatments that Ohio women experienced when health care providers were forced to use outdated FDA protocols for medication abortion, as compared to Ohio women who received care based on the most current scientific evidence.
An Ohio law implemented in 2011 required providers to use the protocol for medication abortion listed on the U.S. Food and Drug Administration (FDA) label, first approved in 2000. This protocol conflicted with the more recent evidence-based protocol supported by several international guidelines and used by most abortion providers throughout the U.S., including Planned Parenthood.
“Despite legislators’ claims that this law was aimed at improving women’s health, the study found no evidence to show that it improved abortion outcomes. In fact, our findings show that the law’s result were quite the opposite,” said lead study author Ushma D. Upadhyay, Associate Professor of Obstetrics, Gynecology and Reproductive Sciences, at UCSF and Advancing New Standards in Reproductive Health (ANSIRH). “Requiring that providers use the older protocol ignores the fact that medical practice is constantly improving as a result of clinical research.”
Today’s study shows that after the Ohio law requiring abortion providers to use an outdated FDA protocol for medication abortion went into effect in 2011, women who had medication abortions had three times the odds of receiving additional medical treatments to complete their abortion and were more likely to experience side effects. There was also an 80 percent decline in the proportion of women choosing medication abortion versus in-clinic abortion procedures — the reverse of national trends.
The research was conducted to explore the abortion outcomes for women who received medication abortion before the 2011 law went into effect compared to outcomes after the law was in place. Using anonymous chart data from 2,783 women who obtained a medication abortion between 2010 and 2014 collected retrospectively from four clinics in Ohio, the researchers were able to examine the proportion of women who received an additional medical intervention to complete the abortion, the experience of side effects, and the rate of medication abortion versus in-clinic abortion procedures in Ohio.
“Mandating that providers follow an outdated clinical regimen has more than a theoretical impact on women’s health. Today’s research shows that Ohio women had three times the odds of receiving additional clinical interventions in the post-law period,” said Dr. Julia Kohn, National Director of Research for PPFA and a co-author on the study. “There are real, negative consequences for people’s lives when politicians legislate medical practice without considering current scientific research.”
Until March of this year, the regimen outlined on mifepristone’s FDA label was based on clinical trials completed in the mid-1990s. Numerous subsequent studies have demonstrated the safety and effectiveness of a regimen using a lower dosage of mifepristone that can also be used two weeks later in pregnancy, up to 70 days since a woman’s last menstrual period. This new regimen has been recognized by the American Medical Association and the American College of Obstetricians and Gynecologists as “superior” to the regimen on the previous FDA-approved label.
It is widely accepted standard medical practice for medicines to be used in different protocols than those upon which the FDA issues approval, based on the most current research. Today’s study further supplements existing research showing the importance of providing care based on the most current medical evidence.
Although the FDA updated the medication abortion label in March 2016 to match the current evidence-based regimen, this new protocol may also become outdated in the future as medical knowledge continues to improve. Providers in Ohio will then again be required to provide care based on legislation, rather than the most up-to-date research and evidence-based medicine. As medicine evolves, it is imperative that health care providers not be restricted in providing care to their patients based on the best medical evidence and practices available.
Authors of the study include: Ushma D. Upadhyay, PhD, MPH; Nicole E. Johns, MPH; Sarah L. Combellick, MPH; and Sarah C.M. Roberts, DrPH, of Advancing New Standards in Reproductive Health (ANSIRH); Julia E. Kohn, PhD, MPA, of Planned Parenthood Federation of America; and Lisa M. Keder, MD, of Ohio State University Wexner Medical Center.
Background on Medication Abortion
- Mifepristone, also known as medication abortion or “the abortion pill” (formerly known as RU-486), is an antiprogesterone drug that blocks receptors of progesterone, a key hormone in the establishment and maintenance of pregnancy. Used in combination with a prostaglandin such as misoprostol, mifepristone induces abortion when administered in early pregnancy, providing women with an alternative to aspiration (suction or surgical) abortion.
- A medication abortion is different than emergency contraception, or “the morning-after pill,” which prevents a pregnancy from occurring.
- Studies show medication abortion has a 99 percent safety record and that medication abortion is up to 98 percent effective in ending an early pregnancy.
- An overwhelming majority of women who choose mifepristone for medication abortion are satisfied with the method. One study found that 97 percent of women would recommend the method to a friend. Additionally, 91 percent of the women reported that they would choose the mifepristone regimen again if they had to have another abortion.
Planned Parenthood is the nation's leading provider and advocate of high-quality, affordable health care for women, men, and young people, as well as the nation's largest provider of sex education. With approximately 700 health centers across the country, Planned Parenthood organizations serve all patients with care and compassion, with respect and without judgment. Through health centers, programs in schools and communities, and online resources, Planned Parenthood is a trusted source of reliable health information that allows people to make informed health decisions. We do all this because we care passionately about helping people lead healthier lives.
August 31, 2016