By Bradley Mattes
Much has been said about the Food and Drug Administration’s 2000 approval of mifepristone, known as chemical abortion.
In his ruling, District Judge Matthew Kacsmaryk said the FDA’s decision is “based on plainly unsound reasoning and studies that did not support its conclusions.” (emphasis added)
Our team has taken a closer look at the studies the FDA relied upon in its political quest to conclude that chemical abortion was both safe and effective.
Here is why Judge Kacsmaryk is right…
The FDA issued a Drug Approval Package for chemical abortion in 2000 that included an application from the Population Council. Its request is heavily redacted, but to the discerning eye it separates fact from current fiction. The American study that the FDA relied upon to approve chemical abortion actually reveals a low level of success of only 77% with pregnancies 8-9 weeks old. Yet the FDA has allowed the drug to be used beyond this window of time.
This study cited by the Population Council, and the French studies mentioned, strongly advise protections for women who use these dangerous drugs. This is advice that the FDA has disregarded in its quest to advance an extreme pro-abortion agenda – mail order abortion drugs without direct medical supervision.
The U.S. study comparing French results was referenced in a medical review (p.18). It states there is a “need for at least three visits to the medical facility including at least a four hours stay after the administration of the misoprostol.” (the second drug)
The medical review (p.20) also included results of a U.S. comparative analysis of chemical abortion to other nations. It points out the “significant” differences in chemical abortion versus surgical procedures. Women “experienced significantly longer postprocedure bleeding…significantly higher levels of pain, nausea, vomiting, and diarrhea.” And women were “routinely offered oral narcotics for…pain.” Post-abortion pain was experienced seven times more often with chemical abortion than with a surgical procedure.
The contraindications, or medical conditions that exclude women from taking mifepristone, are many – with possible serious ramifications if not followed. The study also recommended that girls younger than 18, women over 35 or those who smoke be excluded from using chemical abortion.
The medical review repeatedly referred to “pivotal French studies” that it said supported their claims but did not cite specific studies. A majority of articles written during that time on chemical abortion also mentioned but did not cite two French and one American studies.
Both the New York times and the Washington Post referenced Dr. David Elia’s work, stating he was the person “who organized the clinical trials of mifepristone in France.” A closer look at these studies contradicts the FDA’s erosion of protections that safeguard women from unnecessary risk.
The French studies:
- Required multiple in-person doctor visits.
- Established the exact age of a woman’s unborn child and limited the administration of these drugs to no more than a seven-week pregnancy.
- Provided a thorough briefing for the women taking these pills.
Dr. Elia said, “We tell them to be careful of the bleeding,” pointing out that chemical abortion was not for women with a history of problems with blood clotting. “We are not going to give this method to women who are not able to understand what is going on.” Chemical abortion, he said, was not an easy experience.
A 1985 French study by Dr. Elia included 18 women, and the results showed a dismal success of only 39%. Seven of the women experienced a successful abortion using the chemical abortion pills. Two women required a suction abortion because parts of the babies were retained in the womb. This remains a common problem today with chemical abortion. For the nine remaining women in the study, the drugs had no effect and they resorted to suction abortions.
A 1986 abstract by Dr. Elia and Dr. Andre Ulmann involved 154 women. It is revealing that the authors included this definitive statement: “It is evident that use of RU 486 as an abortifacient will require strict medical follow-up, so that largescale use will not lead to demedicalization of induced abortion.”
Another French study published in 1990 involved approximately 2,000 women and warned against life-threatening complications. “Although infrequent, these possible [hemorrhagic] complications justify medical supervision. In practical terms, the woman must be informed and must have access to adequate medical facilities.”
This study ended with a glowing report on the safety and efficiency of chemical abortion, yet contained a glaring conflict of interest. Five of the six authors worked for Roussel – UCLAF, the manufacturer of the chemical abortion pills. The sixth worked as a consultant to Roussel. This casts obvious doubt over the credibility of the study. A reasonable person would wonder if the data had been altered or fabricated to strengthen their case for worldwide distribution and profits.
A persistent claim from advocates of abortion is that chemical abortion is safer than Tylenol. This ludicrous assertion results from a 2015 decision by the FDA to end reporting of any adverse side effects except for fatalities. As a result, approximately 95% of all complications are going unreported, including emergency room visits and life-threatening situations. But before this coverup, between 2002 and 2015 emergency room visits by women taking chemical abortion pills increased more than 500 percent. Further, they found that 60% of women were miscoded as receiving treatment for miscarriages instead of a chemical abortion.
It is easy to understand how Judge Kacsmaryk concluded that the FDA based its approval of chemical abortion on wishful thinking.
You and I have an opportunity to expose the extreme political agenda of the FDA to approve this chemical coat hanger and jettison protections that provide a measure of safeguards for women.
Defending women and their babies,
Bradley Mattes
President, Life Issues Institute
Life Issues Institute is dedicated to changing hearts and minds of millions of people through education. For 32 years, organizations and individuals around the world have depended upon Life Issues Institute to provide the latest information and effective tools to protect innocent human life from womb to tomb.
This article has been reprinted with permission and can be found at lifeissues.org/2023/05/unveiling-the-truth-behind-the-chemical-abortion-pill-studies.