Reckless Abandonment

Activists Pushing the Abortion Pull Put Women at Risk

The writer of Proverbs cautions us to avoid the path of “sinners.” “For their feet run to evil, and make haste to shed blood” (1:16).

Something about the very nature of bloodshed seems to require “haste.” The natural law is imprinted on man’s heart; his own conscience smites him. So make haste! Quick, act! Before that pesky conscience causes you to stop, reflect, and realize the abhorrence of the evil you are about to commit.

Such has been the case with abortion. A federal judge in Texas recently heard arguments from plaintiffs seeking to overturn the FDA’s approval of the abortion pill mifepristone. In response, pro-abortion groups the nation over are crying out about how crucial mifepristone is for women, especially disadvantaged women. “Mifepristone is perfectly safe!” they shout. It’s safer than other widely used drugs, like penicillin, says USA Today.¹ It’s safer even than Tylenol, says Bloomberg.²

The reality is a lot stickier and makes it look rather suspiciously like the FDA and others are “rushing” to evil, instead of truly trying to determine if women are being put at risk.

A Gathering Cloud of Unknowns

Mifepristone was originally approved by the FDA in 2000. In 2011, it was put under a REMS program (Risk Evaluation and Mitigation Strategy), which placed certain new restrictions on how the drug could be administered. Most importantly, mifepristone was to be administered in person, in a clinical setting. The very fact that the drug was subjected to further evaluation suggests that the FDA knew it carried a risk greater than taking penicillin or Tylenol. Data showing complications associated with its use give even more cause for concern.

On the FDA webpage about mifepristone, one finds the question, “Is it safe to use mifepristone?” The answer, unsurprisingly, is “yes,” but there is a qualification: “Mifepristone is safe when used as indicated and directed and consistent with the Mifepristone Risk Evaluation and Mitigation Strategy (REMS) Program” (emphasis added). Until recently, REMS required that mifepristone be dispensed in-person within “certain health care settings, specifically clinics, medical offices, and hospitals.” In 2021, however, supposedly in response to the Covid-19 pandemic, the FDA lifted the dispensing requirements. After a “comprehensive review,” the FDA stated, “based on the available data and information  . .  . the REMS must be modified to reduce burden on the health care delivery system and to ensure the benefits of the product outweigh the risks” (emphasis added).

Take that in for a moment. The in-person dispensing requirement was modified not because it was no longer deemed necessary, but to “reduce burden on the health care delivery system.” In other words, no, it’s not really ideal to take this drug in other settings, but the health care system is under duress from Covid, so we’re going to allow it anyway. Later in 2021, the FDA permanently removed the in-person dispensing requirement, and mifepristone is now available through the mail.³

The reality is, we really don’t know a lot about how safe mifepristone is, because the very same FDA that supposedly ensures drug safety also modified the reporting requirements. According to a Charlotte Lozier Institute report, “Between 2000 and 2019, over 3,800 adverse events were reported to the FDA, including at least 20 deaths, more than 500 life-threatening complications, and over 2,000 severe complications.”⁴ Outside analysis of this data further suggests that “a significant number” of additional adverse events went unreported and that the FDA may have missed as many as 95 percent of “serious chemical abortion adverse events.” Despite this possibility, in 2016 the FDA amended the reporting requirements to include only deaths; no longer would the agency even hear reports of other serious adverse events.

Furthermore, the FDA’s analysis of abortion data is subject to the same limitations that any other such analysis faces: abortion data in America are woefully inaccurate. The CDC doesn’t require states to report on abortions, and states set the parameters for reporting at their own discretion. In fact, three states—California, Maryland, and New Hampshire—don’t report at all. The CDC estimates that these states account for 20 percent of all abortions.⁵ Other sources have found that self-reporting on abortion is also highly inaccurate, even useless; many women are unlikely to admit they had an abortion.

The good data we do have, according to the Charlotte Lozier Institute report, suggest that post-abortive women who used mifepristone are 53  percent more likely to seek emergency room services than are women who had a surgical abortion and that the frequency of such ER visits is increasing (likely due to increased use of mifepristone). Between 2002 and 2015, as the drug grew in popularity, the rate of ER visits following chemical abortions (abortions using mifepristone) increased by more than 500  percent. Furthermore, as many as 60  percent of visits to the ER following a chemical abortion (as of 2015) have been miscoded as miscarriages, so it’s likely we’re missing even more side effects.

International data from countries where abortion is better tracked suggest the drug isn’t as safe as the FDA claims.⁶ One study out of Finland found that a fifth of all mifepristone users suffered complications. Another study out of Sweden found that those who took the drug at home had a much higher risk of complications than those who took it at a hospital. The potential reasons are many: Mifepristone is only recommended until week 10 after a missed menstrual period, but women who are irregular or simply don’t keep track of their cycles very well can often miss that window and take the drug later than intended. Also, the drug can be dangerous if used on an ectopic pregnancy.

Post-Dobbs Doubling Down

Fast forward to 2023. Roe has been overturned, and abortion advocates have been scrambling ever since to somehow keep abortion in as many states as possible. Since the abortion pill can be obtained through the mail, perhaps they can, with the right legal lingo, use this way to get it to women in more abortion-restrictive states. The abortion pill now accounts for over half of all abortions in America, so limiting access to it would have a substantial impact on abortion rates—hence the battles being waged over it.

In the case of mifepristone, the FDA and other regulatory bodies appear to have rushed into evil. Abortion remains one of the most underregulated industries in America, and the abortion pill is no exception. The only way anyone can maintain that it is perfectly safe is by stopping his ears while singing “La, la, la!” in the face of data that clearly suggest otherwise.

Notes
1. Angela Hill and Karen Rodriquez, “Abortion pill restricted by FDA for decades has better safety record than penicillin and Viagra,” USA Today (July 10, 2020): usatoday.com/story/news/2020/07/10/abortion-pill-restricted-fda-record-safer-than-penicillin-viagra/5412810002.
2. Cynthia Koons, “The Abortion Pill Is Safer Than Tylenol and Almost Impossible to Get,” Bloomberg (Feb. 17, 2022): bloomberg.com/news/features/2022-02-17/abortion-pill-mifepristone-is-safer-than-tylenol-and-almost-impossible-to-get#xj4y7vzkg.
3. Tessa Longbons, “Analysis: FDA Decision Ignores Data on Complications, Puts Women at Risk,” Charlotte Lozier Institute (Dec. 16, 2021): https://lozierinstitute.org/analysis-fda-decision-ignores-data-on-complications-puts-women-at-risk/#_ftn5.
4. Ibid.
5. Jasmine Mithani, “Why accurate data on abortions matters—and why it’s so hard to collect,” The 19th (Feb. 27, 2023): https://19thnews.org/2023/02/abortion-data-rates-after-dobbs.
6. Longbons, ibid. note 3.