Testimony of Denise M. Burke, Esq., Vice President Of Legal Affairs, Americans United for Life, on HB 1086, The Abortion Pill Reversal Information Act,
Before the House Health, Insurance and Environment Committee
February 9, 2017
CHAIRWOMAN JOANN GINAL and MEMBERS OF THE COMMITTEE:
I am Denise Burke, Vice President of Legal Affairs with Americans United for Life. I appreciate the opportunity to provide written testimony on HB 1086, the Abortion Pill Reversal Information Act. In my practice, I specialize in abortion-related legislation and am testifying as an expert in constitutional law generally and the constitutionality of abortion-related laws specifically.
I have thoroughly reviewed HB 1086 which is based, in substantial part, on AUL’s model legislation of the same name. It is my opinion that HB 1086 comports with the requirements that the Supreme Court of the United States has set for informed consent laws for abortion and is, therefore, constitutional.
Informed Consent Laws, Including Those Concerning the Potential to Reverse Chemical Abortions, Are Constitutional
Abortion advocates frequently claim to be “pro-choice,” but they only actually support the choice to have an abortion. As noted in the legislative findings of HB 1086, abortion providers sometimes fail to provide adequate and accurate information to women considering abortions. As a result, many women are physically and psychologically harmed by the abortion process. When a woman is not given comprehensive and medically accurate information, her “choice” to abort is, in reality, no choice at all.
In 1992, in the landmark case of Planned Parenthood v. Casey, the Supreme Court ruled that informed consent laws are constitutional. The Court found that such laws reduce “the risk that a woman may elect an abortion, only to discover later, with devastating psychological consequences, that her decision was not fully informed.”
The Casey Court further acknowledged that “[a]bortion is a unique act. It is an act fraught with consequences … for the woman who must live with the implications of her decision.” Later, in Gonzales v. Carhart, the Court again acknowledged that abortion can have devastating consequences, stating “[i]t seems unexceptional to conclude some women come to regret their choice to abort the infant life they once created and sustained.”
These consequences would seem especially pronounced in situations where a woman regrets her decision to use or ingest an abortion-inducing drug and later learns that she was not told that it might have been possible to reverse the effects of this drug, allowing her to continue her pregnancy and to deliver a healthy child.
Currently, 33 states have enforceable general informed consent requirements. The majority of these laws also include reflection periods for women to consider the information that they have been given in anticipation of making a final decision as to whether or not to have an abortion.
Importantly, states have also enhanced their general informed consent laws for abortion by requiring information on fetal pain, the availability of ultrasounds, perinatal hospice options for women faced with prenatal diagnoses of lethal fetal anomalies, coercion counseling, and, as in HB 1086, the potential ability to reverse the effects of chemical abortions before all of the drugs in the regimen have been ingested.
To date, three states have enacted laws requiring that women be given information about the potential to reverse a chemical or drug-inducing abortion.
In 2016, South Dakota enacted legislation requiring that informed consent for abortion must include information on the possibility of discontinuing a drug-induced abortion and requiring the Department of Health to include such information on its website.
Arizona and Arkansas both enacted AUL’s Abortion Pill Reversal Information Act. In Arizona, the law was enjoined last summer; however, during the 2016 state legislative session, Arizona amend its original law to require that a woman be told that mifepristone (the first drug in the Mifeprex or RU-486 regimen) alone is not always effective to end a pregnancy and that she should consult a physician if she would like more information.
In summary, women need comprehensive information about abortion, its risks and consequences, and its alternatives. When a woman is considering a chemical abortion, this information includes an advisory that the effects of a chemical or drug-induced abortion can be reversed, but time is of the essence. Strong informed consent requirements, such as HB 1086, manifest both a trust in women and a justified concern for their welfare.
The Growing Prevalence of Chemical Abortions
In a 2014 report, the pro-abortion Guttmacher Institute estimated that chemical (or drug-induced) abortions account for 23 percent of all abortions—an increase from 2008, when chemical abortions accounted for 17 percent of all abortions. This increase does not come as a surprise. AUL has long warned of a “chemical abortion revolution” – a marked increase in and emphasis on drug-induced abortions. The growing reliance on chemical abortions further underscores the need for informed consent specific to the efficacy, complications, and alternatives to chemical abortions. HB 1086 satisfies these needs.
What is the Chemical Abortion Process?
Mifeprex (also known as “mifepristone,” RU-486,” or simply the “abortion pill”) is currently the only chemical abortion regimen approved for use in the United States. Mifeprex is used, together with another medication called misoprostol, to end a pregnancy. The FDA first approved Mifeprex in 2000, and later amended approved guidelines for its use in March 2016.
The 2016 FDA-Approved Regimen
Mifeprex is approved, in a regimen with misoprostol, to terminate a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period). The FDA-approved Mifeprex dosing regimen is:
- On Day One: 200 mg of Mifeprex taken by mouth
- 24 to 48 hours after taking Mifeprex: 800 mcg of misoprostol taken buccally (in the cheek pouch), at a location appropriate for the patient
- About seven to fourteen days after taking Mifeprex: follow-up with the healthcare provider
Women Should Be Informed that Chemical Abortions Can Be Reversed
Because physicians know that mifepristone, the first drug in the Mifeprex or RU-486 regime, works by blocking progesterone, it is possible to reverse the effects of the drug by flooding the woman’s body with progesterone. The process (which has been detailed in a peer-reviewed study) is based upon a well-established medical regimen that is used in other areas of healthcare: a methotrexate and “leucovorin rescue.”
Methotrexate, a common chemotherapy drug, kills rapidly dividing cells (e.g., cancer cells). Specifically, it blocks the action of folic acid. Typically, physicians allow the methotrexate to work for a day or two, and then give the patient a high dose of folic acid (leucovorin) to compensate for what has been lost. This high dosage of folic acid, in essence, “kicks” the methotrexate off of the cells. This flooding of the patient’s body with folic acid is called a “leucovorin rescue” and is a well-established medical procedure.
Similarly, since physicians know that mifepristone works by blocking progesterone, they also know that treating a woman with progesterone can “kick off” the mifepristone. This allows the woman’s body to respond naturally to the progesterone and to effectively fight the effects of the mifepristone.
Progesterone itself has been used safely in pregnancies for decades. It is used in in vitro fertilization, infertility treatments, and high-risk pregnancies (such as those experiencing pre-term labor). Using progesterone to reverse the effects of mifepristone is a targeted response that is safe for women.
For a woman who regrets her decision to use the first drug in the RU-486 regime (mifepristone) and wishes to continue her pregnancy, knowledge of this potential reversal option could mean the difference between the life and death of her baby. Abortion Pill Reversal, an organization that assists women in locating physicians trained in the reversal process, reports a 55 to 60 percent success rate for women who attempt to reverse the effects of mifepristone. As of May 2016, 175 babies had been born and another 100 were on the way (i.e., still in utero), following the reversal process.
Clearly, it is important that a woman contemplating a chemical abortion be informed that the process can be reversed. HB 1086, which is based on AUL’s Abortion Reversal Information Act, mandates that women be informed of this possibility.
Dangers of Chemical Abortions
There is another reason why women should be informed that chemical abortions can be reversed: the two-drug, multi-day chemical abortion process has substantial – and sometimes deadly – consequences for women’s health and safety.
Importantly, the manufacturer of Mifeprex admits that “[n]early all of the women who receive Mifeprex [RU-486] and misoprostol will report adverse reactions, and many can be expected to report more than one such reaction.” These adverse reactions include, but are not limited to, abdominal pain, cramping, vomiting, headache, fatigue, uterine hemorrhage, viral infections, and pelvic inflammatory disease.
In July 2011, the FDA reported 2,207 adverse events in the U.S. after women used RU-486. Among these were 14 deaths, 612 hospitalizations, 339 blood transfusions, and 256 infections (including 48 “severe infections”). Of the reported deaths, eight were from severe bacterial infections. All eight women administered misoprostol either vaginally or buccally (i.e., in what was then an off-label, unapproved manner).
Further, the Mifeprex or RU-486 regimen is particularly dangerous because its side effects are confusingly similar to the symptoms of an ectopic pregnancy. Failing to properly diagnose an ectopic pregnancy can lead to a rupture of the fallopian tube, causing bleeding, severe pain, and even death.
Chemical Abortions Pose More Complications than Surgical Abortions
Medical evidence demonstrates that chemical abortions can pose more significant risks to women than surgical abortions. Importantly, peer-reviewed studies have also found that the overall incidence of immediate adverse events is fourfold higher for chemical abortions than for surgical abortions.
In particular, hemorrhage and incomplete abortions are more common after chemical abortions. A 2009 study found the incidence of hemorrhage is 15.6 percent following chemical abortions, compared to 5.6 percent for surgical abortions. It also found 6.7 percent of chemical abortions result in incomplete abortions, as compared to 1.6 percent of surgical abortions. Further, 5.9 percent of women required surgery after failed chemical abortions.
An earlier 1999 study found that chemical abortions failed in 18.3 percent of patients and that surgical abortion failed in only 4.7 percent of patients. It also found that patients who undergo chemical abortions also report significantly longer bleeding and higher levels of pain, nausea, vomiting, and diarrhea than women who undergo surgical abortions.
Significantly, chemical abortions pose a greater risk of bacterial infection than do surgical abortions. The CDC has found a risk of death from C. sordelli (bacterial infection) in a chemical abortion is ten times the death rate from all causes following a surgical abortion at a comparable gestational age.
Moreover, the American College of Obstetricians and Gynecologists (ACOG) admits that chemical abortions fail more often than surgical abortions.ACOG takes special note that chemical abortions require multiple visits to a healthcare provider, while surgical abortions usually require only one visit, and that chemical abortions can take days or weeks to complete, while surgical abortions take shorter, more predictable periods of time. Finally, chemical abortions require patient participation throughout a multistep process, while surgical abortions require patient participation in a single-step process.
Informing women that chemical abortions can be reversed potentially allows women to reduce the health and safety risks associated with using or ingesting the two-drug regimen.
 See, e.g., Speckhard & Rue, Post-Abortion Syndrome: An Emerging Public Health Concern, J. Soc. Issues 48(3): 95-119 (1982) (reporting that 81 percent of women surveyed felt victimized by the abortion process).
 505 U.S. 833 (1992). The Supreme Court has also refused to review a lower court ruling which found Mississippi’s informed consent law constitutional. Barnes v. Moore, 970 F.2d 12 (5th Cir. 1992), cert. denied, 506 U.S. 1013 (1992).
 Planned Parenthood v. Casey, 505 U.S. at 882.
 Planned Parenthood v. Casey, 505 U.S. at 852.
 Gonzales v. Carhart, 550 U.S. 124, 159 (2007).
 Twenty-seven states require informed consent with a one-day reflection period (usually 24 hours): Alabama (48 hours), Arizona, Arkansas (48 hours), Florida (reflection period in litigation), Georgia, Idaho, Indiana (18 hours), Kansas, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri (72 hours), Nebraska, North Carolina (72 hours), North Dakota, Ohio, Oklahoma (72 hours), Pennsylvania, South Carolina, South Dakota (72 hours), Tennessee (reflection period in litigation), Texas, Utah (72 hours), Virginia, West Virginia, and Wisconsin.
Six states require informed consent with no reflection period: Alaska, California, Connecticut, Maine, Nevada, and Rhode Island.
Three states have enacted informed consent laws that are in litigation or enjoined: Delaware, Massachusetts, and Montana.
 Guttmacher Institute, Abortion Incidence and Service Availability in the United States, 2011 (Mar. 2014), available athttp://www.guttmacher.org/pubs/journals/psrh.46e0414.pdf (last visited July 10, 2015).
 See “Mifeprex (mifepristone) Information ,” available at http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm (last visited February 3, 2017).
 See Mifeprex FPL, supra (emphasis added).
 Id. at 12 (Table 3).
 FDA, Mifepristone U.S. Postmarketing Adverse Events Summary Through 04/30/11 (July 2011), available athttp://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM263353.pdf (last visited July 10, 2015).
 Id. It is important to note that the FDA, in its revised 2016 guidelines for Mifeprex, sanctioned the administration of the drug buccally. Prior to March 2016, however, such administration violated FDA guidelines.
 M. Niinimaki et al., Immediate Complications after Medical compared with Surgical Termination of Pregnancy, Obstet. Gynecol. 114:795 (Oct. 2009).
 J.T. Jenson et al., Outcomes of Suction Curettage and Mifepristone Abortion in the United States: A Prospective Comparison Study, Contraception 59:153-59 (1999).
 M. Fisher et al., Fatal Toxic Shock Syndrome Associated with Clostridium sordelli after Medical Abortion, N.E. J.M. 353:2352-60 (2005).
 ACOG, ACOG Practice Bulletin 67 Medical Management of Abortion, at Table 2. See also J.T. Jenson et al., supra.