Wendy Wright

In September 2000 the Food and Drug Administration approved the drug mifepristone—also known as RU-486—for use with prostaglandin in early nonsurgical abortions. In the following viewpoint, Wendy Wright contends that this “abortion pill” has side effects that are dangerous for women. RU-486 abortions involve more pain, blood loss, trauma, and risky side effects than the drug’s promoters have acknowledged, she maintains. Moreover, Wright argues, the Food and Drug Administration’s lax standards will result in irresponsible administration of the hazardous drug. Wright is the director of communications for Concerned Women for America, a conservative advocacy organization.

As you read, consider the following questions:

1. According to Wright, why are women who take RU-486 at greater risk for infections"
2. Who will be qualified to administer RU-486, according to the author"
3. Where will RU-486 be manufactured, according to Wright"

Fiona,” a 30-year-old divorced mother of two in Great Britain, had previously experienced a surgical abortion. Then she had an RU-486 abortion, and it turned out to be harder than she expected.

“I took the first three tablets,” she said. “The process had started and it was inevitable. But you have so long to reflect on it, and I became quite upset.

“The second stage was pretty awful. After taking [the drug to induce contractions], the pain became very strong. It was just like early labor. I remember finally dispelling the fetus. The nurse told me it was ‘beautifully formed.’

“[This method] may be physically more natural, but psychologically it hits you much harder. You preside over the killing of a baby, completely unblinkingly.”

A Deadly Decision

On September 28, 2000, the Food and Drug Administration (FDA) approved RU-486 (mifepristone) for use in the United States. At a Concerned Women for America press conference held that day, this controversial decision provoked an outcry from doctors, women, legislators and attorneys familiar with the “abortion pill.”

The chorus of disapproval—which extends beyond the pro-life community—expressed concern over the drug’s dangers, tainted testing, the decision’s political timing, and the surprising lack of protections for women.

How could the FDA get it so wrong?

Fox Guarding the Hens

The process of testing and approval in the United States has hardly been impartial. Danco Laboratories has only one product: RU-486. Danco, which was created by the pro- abortion Population Council, holds the patent for RU-486. It raised funds from population-control advocates and relied on testing done by abortion clinics. Pressure from abortion-rights groups and politicians may have led to covering up negative results from U.S. trials.

Dr. Mark Louviere is an emergency room physician in Iowa. He treated a woman in shock from severe blood loss due to an incomplete abortion. Informed that she had been part of the RU-486 clinical trial at Planned Parenthood in Des Moines, Dr. Louviere notified the clinical trial’s director and sent the patient’s medical record to be included in the study. Yet the trial’s report claimed no complications [were] reported among the 238 women who ended unwanted pregnancies without surgery.

“If near death due to loss of half of one’s blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication,” wrote Dr. Louviere in the Waterloo [Iowa] Courier, “I don’t know what does.”

The medical dangers of RU-486 are no secret. In 1995, medical experts, scientists and 24 members of Congress filed a 64-page study with the FDA documenting them. In a petition, they said European data on RU-486 were unreliable, that serious potential complications exist if treatment protocol is not strictly followed, and discussed the lack of long-term studies. The FDA never responded.

Another risk is breast cancer. In 1996, Dr. Joel Brind, a leading researcher on the link between abortion and breast cancer, testified at the FDA’s advisory committee hearing on RU-486. He advised the agency then not to approve the drug and repeated his concern at our September press conference. “Of a certainty, thousands upon thousands of women will get breast cancer because they took this drug,” Dr. Brind said.

The FDA also failed to acknowledge another common, but rarely mentioned, side effect: infections. Lawrence Roberge, scientist, professor and author of The Cost of Abortion, found that RU-486 suppresses a woman’s immune system. Combined with the contraction-inducing companion drug (misoprostol), RU-486 renders her body powerless to fight off bacterial infections.

“The problem is further complicated,” reported Mr. Roberge, “if the woman using RU-486 has HIV/AIDS or other immunosuppressive diseases, since any infection would almost certainly . . . become a cause for a possible patient death.”

A Willing Accomplice

President Clinton has been a key player in RU-486’s approval. On his third day in office in 1993, he lifted former President Bush’s ban on the drug and has seemingly accelerated the approval process.

“FDA review time for RU-486 was a mere six months, . . . even faster than the average time for ‘fast-tracked’ drugs,” said Sen. Tim Hutchinson (R–Arkansas) at our press conference. “In this case, the administration rushed a drug through that will take lives instead of save them.”

The president and FDA Commissioner Jane Henney insist the decision is one of science and medicine, not politics. However, the FDA ignored scientific information and unanswered questions. Its approval was glaringly void of protections for women.

Who’s In Charge Now"

In June 2000, abortion groups leaked to media that FDA approval might come with “limits” or “unprecedented demands on doctors.” They didn’t need to worry. The FDA’s lax requirements allow RU-486 to be “provided by or under the supervision of a physician [emphasis added].” This means the physician should know how to determine the pregnancy is no more than seven weeks long and be qualified to diagnose ectopic pregnancies. He or she must be able to provide or refer for surgical abortion when RU-486 fails.

However, the physician can delegate anyone to actually administer the drug. No qualifications were established as to who can work “under the supervision of a physician,” leaving the door open for receptionists, janitors, literally anyone to do the deed.

The FDA directs the physician to report babies that survive RU-486 and are not surgically aborted, as well as any hospitalization, transfusion or other complications, to Danco—the very company that has a vested interest in hiding or ignoring them. The FDA’s approval relies on two accomplices, the abortionist and the drug marketer, to document problems.

“The FDA’s conditions for approval are only recommendations; they are not requirements,” said Denise Burke of Americans United for Life, a pro-life legal defense organization. “There are few incentives other than the threat of malpractice lawsuits to prevent physicians from prescribing and using RU-486 in violation of these recommendations.”

Further, training of medical personnel about RU-486 falls far short. In 1996, Susan Allen, M.D., who led a company set up by the Population Council, testified before an FDA advisory panel on RU-486. Allen proposed that physicians with no abortion training or experience attend brief seminars to learn to date pregnancies, manage complications, and perform surgical abortions as a back up. Panelist Vivian Lewis, M.D., objected, calling such persons “the worst possible choice.” Susan Allen now heads the FDA division that oversees the drug’s release.

Risks of RU-486

• Intense pain, nausea, vomiting, diarrhea, headache, back pain, dizziness
• Extreme blood loss. During U.S. trials, four women needed transfusions.
• According to the New England Journal of Medicine, 65 women in the study required hospitalization and received surgical intervention and intravenous fluids.
• No long-term studies of the cancerous potential of RU486 (mifepristone) have been conducted. However, 27 studies worldwide attest to abortion’s link to breast cancer.
• There are no studies on the safety of RU-486 for women under age 18 or long-term effects on women’s reproductive health.
•Birth defects are possible in the case of an incomplete abortion.

Family Voice, November/December 2000.

The National Abortion Federation (NAF), a trade association of abortionists, has taken the lead in RU-486 training. It has proposed changing the RU-486 protocol practiced in Europe for 12 years. Its suggestion? That women no longer take misoprostol, which follows RU-486 and induces contractions, under a doctor’s supervision.

“Having a group of women doing a lot of bleeding and cramping in your office, when they would rather be home, doesn’t do much for the [patient] flow in your clinic,” said NAF president Dr. Suzanne Poppema.

Made in China

As if side effects, complications and inadequately trained medical personnel weren’t enough, women who take RU486 must also be concerned about where and how the drug is manufactured. The risk that a “healthy” woman would use RU-486 and be injured, or “have a child born with abnormalities,” was enough for U.S. drug companies to steer clear of the abortion pill, according to the Reproductive Health Technologies Project.

“As soon as our attorneys learned that it is only 95 percent effective, they began to scream,” said one pharmaceutical company executive in The Political History of RU-486. “The other 5 percent could involve defective children and that, in terms of liability suits, could blow us out of the water.”

So Danco looked to a country known for its contempt for human rights. The Washington Post has confirmed Danco has contracted with a company in China to manufacture the pill. Eight senators wrote to the U.S. Secretary of Health and Human Services on September 21, 2000. They asked the FDA to delay a final decision until serious concerns about the manufacturer were answered. Not only do the questions remain unanswered, but the Clinton-Gore administration had allowed the manufacturer to remain secret from the American public.

This development comes in light of recent hearings held in the U.S. House Commerce Committee’s Oversight Subcommittee that criticized the FDA for failing to adequately protect the public from dangerously tainted imported drugs. The hearings cited China as a major supplier.

Upon release of the FDA’s approval, the response on Capitol Hill was immediate.

“Congress has a duty to ensure that RU-486 kills only one person instead of two,” stated Rep. Tom Coburn (R- Oklahoma), who is also a family physician, as he introduced a bill to institute protections for women. “Congress now has the unenviable task of correcting the FDA’s mistake.”

Going a step further, Dr. Coburn said in this case malpractice suits may succeed where politics may fail. At the press conference, attorney Gerard Mitchell, whose firm has obtained a judgment for more than $7 million for an abortion injury, described medical malpractice claims that may result from RU-486.

“RU-486 is insufficiently studied to be allowed into consumers’ hands,” Mr. Mitchell warned. “Foreseeable and predictable side effects will include infections, bleeding, and delivery of damaged but viable infants, as well as long-term health risks.

“Counsel for injured women, and for the injured children who survive this terrible drug, will see to it that the truth about RU-486 is told in courtrooms across America. The consequences for those responsible for the distribution of this terrible drug will be severe,” he stated.

Physicians, congressmen, scientists, attorneys and women who have been hurt by abortion have all denounced RU-486. Only, it seems, abortion activists celebrated the FDA’s approval. But where will they be after RU-486 has done its deadly deed? They claimed the decision was one of “science and medicine.” But the evidence indicates it was one of malice toward life. Sooner than later, the truth will be clear.