It’s completely reasonable for people to disagree about the morality of abortion. It’s completely unreasonable — and unethical — for medical professionals and those masquerading as them to give potentially life-endangering misinformation about it.
Abortion by medication has been available in the United States since 2000, when it was approved by the Food and Drug Administration. The regimen consists of two pills taken 24 to 48 hours apart. The first pill, mifepristone, blocks the hormone progesterone, which is required for pregnancy. The second pill, misoprostol, causes the uterus to empty. This two-pill approach is currently used in 39% of all abortions in the U.S., a proportion that has been increasing over time.
Medication abortion is safe and effective, with a serious complication rate of only 0.4%. Despite this safety record, the FDA still employs strict guidelines that allow only certified providers to dispense this medication regimen in a clinical setting — a physician can’t send a prescription to a pharmacy, for example, and have the patient pick it up there and take the medication at home. Experts say this is overregulation.
Medication abortion has been the target of attacks at the state level. Thirty-four states allow only physicians to prescribe it and ban other qualified medical professionals, like nurse practitioners, from prescribing it. And 18 states require that a physician be present when the medication is handed to the patient. (An effort underway is studying the safety of getting these medicines by mail and taking them at home.)
Here’s where things get really muddled: Six states currently mandate that women be counseled that a medication abortion can be reversed, despite evidence that women are certain of their decision to have an abortion and 99% of them feel relief — not regret — five years later. These mandates stem from one report of six women who were given only mifepristone, the first pill, and then given high doses of progesterone to reverse it. This study was not ethically approved and the results do not differ from what happens when only mifepristone is taken.
To examine if reversal actually works, a different team of researchers conducted a randomized clinical trial using a registered research protocol. They enrolled pregnant women who planned to terminate their pregnancies and who were willing to delay the termination by up to two weeks. All women received mifepristone and were then randomized to receive either high-dose progesterone (the “reversal” group) or a placebo (the controls).
The study had to be stopped prematurely because of serious medical concerns that occurred after only 12 patients had been enrolled. Three women in the reversal group (25%) had to be taken to the hospital and required emergency medical care for severe bleeding. This is more than 60 times the serious complication rate associated with the approved medication abortion regimen.
The researchers concluded that “laws should not mandate counseling or provision of any treatment when we do not fully understand treatment efficacy (including best route of administration, dose, and duration) and safety.” The results of that trial indicate that reversal of a medication abortion is potentially dangerous, and should be considered “experimental.”
In spite of this, mandated counseling, especially counseling delivered in crisis pregnancy centers, perpetuate the claims that medication abortion reversal is an option. There are approximately 2,500 crisis pregnancy centers in the U.S. today, which is more than three times the number of abortion care clinics. In my home state of Indiana, where I am a pediatrician, 98 crisis pregnancy centers have been identified.
These centers, usually located near abortion clinics and designed to resemble family planning facilities, are often not licensed, are staffed by volunteers without clinical training or professional licenses, and are not required to follow standard protections for patient privacy or informed consent. In addition to providing misleading information about reversal of medication abortions, these centers often disseminate inaccurate information about sexually transmitted infections and contraception.
And yet, crisis pregnancy centers often receive funding from state and federal governments. Due to recent changes in federal family planning Title X funding requirements, crisis pregnancy centers are expanding their ability to qualify for these funds. Some school districts even contract with crisis pregnancy centers to provide sexuality education, despite the mounting evidence that their curriculum is ineffective and harmful.
The Society for Adolescent Health and Medicine and the North American Society for Pediatric and Adolescent Gynecology recently issued a joint position statement regarding crisis pregnancy centers. In essence, it says that these centers violate core ethical and medical standards with regard to reproductive health and informed consent and should be held to established standards. This seems obvious to me, but clearly needs to be amplified.
Medication abortion is safe. Reversing it is not. It is wrong and unethical that organizations promote this concept to women and that physicians in some states are required by law to counsel women to consider such a dangerous thing. Instead, we should be striving to provide evidence-based, compassionate, and patient-centered care to all women.
Tracey Allyson Wilkinson, M.D., is an assistant professor of pediatrics at Indiana University School of Medicine.