(Un)happy birthday, chemical abortion

September 28, 2020 marked the twentieth anniversary of the U.S. Food & Drug Administration (FDA)’s approval of Danco’s application to market RU-486, a drug regimen intended to cause abortion in early pregnancy. After initial reluctance by women to accept its risks and a vigorous national campaign by abortion advocates to normalize and market it, chemical abortion now accounts for nearly 40% of all U.S. abortions.

From the beginning, chemical abortion has been promoted under a banner of false assurances and half-truths. Now, two decades into this dangerous experiment with women’s lives, the duplicities have worn thin, even as pro-abortion advocates in the U.S. and abroad have redoubled their energies to make it available without limitations. But in its 20-year history, the known risks and complications of RU-486 have not changed. The drug has not become more safe or effective for women. The only thing that constantly changes is the amount of risk of death and physical injury the abortion industry thinks women should be willing to accept to obtain a chemical abortion.

Over the next few weeks, Advocates for Life will take a hard look at chemical abortion: its genesis in France and adoption in the U.S., the known risks that caused the FDA to approve it only upon stringent conditions, and the ways in which abortion advocates are pushing increasingly dangerous risks on women for the sake of abortion access and their bottom line.

Abortion proponents frequently charge that opposition to chemical abortion is simply political. Their narrative is that the process of getting RU-486 approved and marketed, first in France, then in America and abroad, has been a victory of medical science over anti-abortion politics. But actually, the opposite is true; both initially in France and in the U.S., approval was politically driven, and promotion continues to be political, anti-science and anti-woman.

“RU” stands for “Roussel Uclaf,” the French pharmaceutical company that synthesized the drug’s principal compound, the steroid mifepristone, in 1980. After initial tests suggested the drug was a progesterone antagonist along the lines of what some Roussel Uclaf scientists were looking for to interrupt pregnancy, the drug was rushed through seventeen months of animal studies before being declared “safe” and promising enough to warrant human clinical trials. The first study in Geneva in 1981 involved eleven women. It was a disaster, with one woman hospitalized for a blood transfusion and surgery. In spite of this, trials began on women in eight countries including the U.S., with RU supplying the drug and its staff and consultants to co-author the publications that resulted. “Success rates” varied from 54 percent completed abortions upward, but none compared to the extremely high completed abortion rate for surgical abortion. This didn’t keep the publications from hailing RU-486 as a medical “breakthrough”. RU added prostaglandins, which had been used since 1970 to induce uterine contractions in spite of warnings against it by international health organizations, to the mifepristone dosing regime. No trials, however, assessed the potential adverse effects from the interaction of the two drugs. The studies remained small through the 1980s, and the publications that continued to project optimism about an RU 486/prostaglandin (PG) combination were dominated by Roussel Uclaf researchers.

As Renata Klein, a pro-choice feminist writer, put it in RU-486: Myths, Misconceptions, and Morals (Spinifex Press Aus. 1991), “The history of RU 486 took a dramatic turn in 1988,” when Roussel Uclaf received a license to market RU 486 from the French Ministry of Health. The ministry abruptly suspended the distribution within a few months, and the media blamed the move on pro-life political pressure. Two days later, the press reported that the French Minister of Health had ordered Roussel Uclaf to put RU 486 back on the market. The minister stated that the drug had become “the moral property of women.” 60,000 French women took the drug over the next three years in a de facto large-scale human trial sponsored by the French government – which, perhaps not coincidentally, owned 36.25 per cent of Roussel Uclaf. But the French government initiated four sets of rules on distributing the drug in France, and listed it as a poisonous drug that threatened health in some instances. A lawsuit against the issuance of the license ended with a decision by  France’s highest administrative court, the Council of State, which ruled that the government had no authority to mandate the drug’s marketing.

Roussel Uclaf wrote up mandatory prerequisites for a country to have before they would market it there. These included that the country had to have legalized abortion, and the nation’s culture had to be accepting of abortion. In a U.S. congressional hearing, a Roussel Uclaf representative testified that she did not think America met those standards.

A strident promotional campaign for the approval of RU-486 began in the U.S. and abroad, which charged that opposition to the drug could only come from anti-abortionists. The Feminist Majority promoted RU-486 in the U.S. by “amassing thousands of signatures in a petition drive designed to pressure Roussel Uclaf to license and/or distribute the drug in the United States,” while depending for authority “wholly on studies and statements prepared by the drug researchers,” according to Klein. The Feminist Majority issued a “Communique” in 1990, on the eve of RU-486 approval, charging that “Both women’s health care and freedom of research are being sacrificed by allowing anti-abortion extremists to block the production and distribution of RU 486.” The pressure from feminist groups was so strong that Klein says it threatened to eliminate the possibility of objective consideration of the drug:

There is… an urgent need for more informed feminist discussion of RU 486/PG, but not on the terms of the anti-abortionists. This discussion has been muted by the proponents’ accusation that any woman who raises objections to the drug is playing into the hands of the right wing. Presumably, the recognition that women have independent critical judgements has been one of the vital legacies of this wave of feminism. Women have the right to safe and effective abortions, but women also have the right to question whether RU 486/PG fulfills those claims.

In 2000, the federal Food and Drug Administration (FDA) approved the new drug application for Mifeprex (RU-486), the first and only drug approved to terminate early pregnancy. However, it did so with important restrictions intended to protect women experiencing abortion, including that it be obtained in person directly from a clinician licensed to prescribe and administer these drugs. Over the years, and with updated information, these regulations have changed, but the core premises—appropriate treatment and administration—have stayed the same. We’ll examine how these core premises have held up in the days and weeks to come.