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RU-486 underwent clinical trials in the United States in 1994 and 1995, and the data, along with the results of the French tests, were submitted to the FDA. In 1996, the agency ruled that the drug met its safety qualifications but needed further labeling restrictions prior to final approval.
The process then took a somewhat unusual tack. RU-486 ended up being approved under an accelerated FDA protocol called Subpart H, which is normally used to speed approval of drugs for life-threatening illnesses such as cancer or AIDS. Such drugs carry added restrictions that give the FDA more control over their end use.
Both sides of the RU-486 debate criticized the use of Subpart H. The drug's developers felt they already had proposed enough restrictions -- doctors would have to order direct from Danco, attest to their competency to administer the drug, record the serial number of each pill packet used, and promise to give the patient counseling and have her sign consent forms.
The drug's critics complained for a different reason. They claimed RU-486 was fast-tracked under pressure from the Clinton White House at the expense of patients' safety.
Both the FDA and abortion-rights supporters contest this claim. "The reason Subpart H was used and introduced late in the process by the FDA was so they could impose additional restrictions on how it is distributed," says Population Council Vice President Sandra Arnold. "The contention that these were rushed or inferior studies is wrong."
In the end, the FDA agreed to Danco's labeling proposal, and Mifeprex came to market in November 2000. Its availability changed American abortion politics in two very significant ways. First, it meant hospitals and private practitioners, not just clinics, could provide abortions. That made it harder for right-to-lifers to figure out where to picket. "They thought they wouldn't be able to target providers in the same way because there would be more people doing it privately in their practices," says the National Abortion Federation's Saporta.
Perhaps more significantly, RU-486 was designed for use early in pregnancy. While antiabortion activists may believe life should be protected from conception onward, the American public is more accepting of early-stage terminations. "The majority of people in this country are comfortable with very early abortions," says Cynthia Gorney, a UC Berkeley journalism professor and author of Articles of Faith: A Frontline History of the Abortion Wars. "They don't have a giant psychological problem with them when there's no visible body parts or other things we associate with a human life. Most pro-lifers disliked RU-486 because they understood people don't really have a problem with that. How do you counter it? You get at its hazards."
This is what made Holly such an effective emblem -- she went from healthy all-American to terminal ICU patient in a matter of days. Before Holly's death, RU-486 had a solid safety record after more than a decade of use. It had been linked to just three deaths: a Canadian woman who died of a rare clostridium infection during clinical trials, a French woman who used it despite being a heavy smoker -- a known risk factor -- and a Tennessee nurse named Brenda Vise, who died when Mifeprex was administered to abort what turned out to be an ectopic pregnancy. The drug isn't supposed to be used for ectopic pregnancies, which occur in the fallopian tube rather than the womb.
Medical abortion is considered just as safe as surgical abortion, which is one of the most commonly performed elective surgeries in the United States -- approximately 1.3 million abortions are performed domestically every year. According to the nonprofit Alan Guttmacher Institute, one in three American women will have had an abortion by age 45. "The risk of dying from having a medical or surgical abortion is far, far less than if the patient carried the pregnancy to term," says Dr. Mark Nichols of Oregon Health and Science University, who participated in the RU-486 clinical trials. "The risk of dying is about 1 in 10,000 when a pregnancy is carried full-term, whereas the risk of dying from an abortion in general is maybe 1 in 200,000."
Mifeprex's supporters also point out that no medicine is completely safe. "All drugs carry some risks. The FDA approval saying a drug is safe and effective does not mean 'without risk.' It means the benefits outweigh the risks," says Danco spokeswoman O'Neill. "Our reported adverse event rate overall is less than 0.2 percent, which is a very low rate."
UC Berkeley embryologist Malcolm Potts concurs that mifepristone has a good safety record. "Every drug -- and we can use aspirin as an example -- has a mortality, and that's always tremendously sad," he says. "Abortion is always one of the most common procedures a gynecologist does, and sooner or later someone's going to die."
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