Mifepristone's Uses Grow; Attacks Do Too

The pill formerly known as RU-486 is becoming more widely used-both in medical abortions and as possible treatments for uterine fibroids, some cancers, psychosis, Alzheimer's and AIDS.

Vicki Saporta

(WOMENSENEWS)-A diary in a Chicago women's clinic may be the best measure of the quiet revolution of medical abortion using mifepristone, once known as RU-486, as an alternative to surgical abortion.

“Being able to deal with the medical abortion at home was good. I've had to walk past protesters throwing eggs to get a surgical abortion. Thanks . . . for an easier, more private option,” wrote one patient.

Use of the mifepristone pill regimen is growing steadily, say abortion providers. In addition, new medical studies show it has great promise in the treatment of diseases ranging from uterine fibroids to acute psychotic depression.

But with medical breakthroughs on the way, three anti-choice organizations have unleashed a new assault on mifepristone, filing a citizen's petition with the U.S. Food and Drug Administration in late August to demand that distribution be “immediately halted.”

Groups Have Been Waiting to File Petition Since Drug Was Approved

Anti-choice groups fought mightily to keep mifepristone from American women. European women could request the abortion pill by 1988, but testing was not allowed in the United States until President Clinton lifted a ban as one of his first acts in office in 1993. Approval for manufacture and distribution was granted in September 2000.

“For 22 months-that's how long we've looked at filing this petition,” said Wendy Wright, spokeswoman for Concerned Women of America, an ultra-conservative policy organization that is one of the petitioners, along with the Christian Medical Association and the American Association of Pro Life Obstetricians and Gynecologists. The petition asserts that the original FDA-approval process was flawed and “manipulated from the outset.” The FDA has six months before it must formally respond.

Heather O'Neill, director of public affairs for Danco Laboratories LLC, which manufactures and distributes mifepristone in the United States under the brand name Mifeprex, flatly denies any merit to the claim. “The FDA approval process was rigorous in all aspects. It was careful and thorough,” said O'Neill. She noted that the drug has now been used safely and successfully by 900,000 women in over 25 countries.

As an antiprogestin, mifepristone blocks the action of progesterone, a hormone necessary to sustain a pregnancy. The uterine lining changes, resulting in a detachment of the fertilized egg. Misoprostol, taken a few days later, is a prostaglandin, which causes the uterus to contract and expel the detached tissue. A follow-up visit ensures that the abortion is complete.

A letter released by Danco Laboratories in April reminded doctors that Mifeprex should not be used in an ectopic pregnancy, when a fertilized egg becomes implanted in a fallopian tube or other area outside of the normal uterine cavity. The petitioning groups point to it as an admission of failure and insist that four reported incidents of injury and two deaths show it is unsafe, even though the FDA determined that no causal relationship had been established between mifepristone and the incidents.

“They are trying to frighten women from having medical abortions by medical misinformation,” said Vicki Saporta, executive director of the National Abortion Federation, which represents abortion clinics.

More Women Choosing Earlier Abortions

Mifepristone is being positively received on other fronts. California Gov. Gray Davis signed a bill this month that improves access for women by permitting nurse practitioners, or any other medical professionals supervised by a doctor, to give the pill to patients.

Sales of mifepristone are increasing steadily in the U.S., according to abortion providers.

“We've seen remarkable acceptance and success,” said Saporta. Seventy percent of the 335 U.S. clinics that are members of the National Abortion Federation offer mifepristone. Saporta said the organization has trained over 4,000 health-care providers and is launching a five-hour online training. Results of a not-yet-released National Abortion Federation study completed this summer show that 28 percent of women patients chose mifepristone when available and they were medically eligible, said Saporta. “As women learn more and physicians have more experience, the number is increasing,” she said.

Women can consider the nonsurgical abortion alternative during the early weeks of pregnancy, up to 49 to 56 days after their last menstrual period. Private doctors without facilities to perform surgical abortions can now prescribe mifepristone in their offices, a use that Danco said is growing. Planned Parenthood/Chicago Area, which provides more than 7,000 abortions a year, will soon expand Mifeprex availability to locations that previously had only gynecological care, said Lorie Spear, director of surgical services there. More than 1,000 abortion patients-approximately one in four of those who are eligible-chose mifepristone in the past year and a half, Spear said.

A surprising secondary trend developed, too, she said. The number of early surgical abortions-those performed within the first eight weeks of pregnancy-rose by 60 percent. Early abortions accounted for 42 percent of total abortions in the past year, compared to only 19 percent prior to the introduction of mifepristone. Spear believes that mifepristone is helping women focus on all early options, including technology introduced in the last five years that permits surgical abortions after only three weeks of pregnancy.

Research Indicates a Possible Plethora of Uses

Medical research with mifepristone has uncovered a plethora of possible health-care benefits. “It's treating all these diseases that no other drug can treat,” said Dr. Beth Jordan, an internist who, as the first medical director for the Feminist Majority Foundation, is overseeing studies for other uses of mifepristone, as well as cases of compassionate use for patients with terminal or life-threatening illnesses who have failed other treatments.

An initial study on uterine fibroids conducted by investigators at the University of Rochester Medical Center found “excellent regression” of women's tumors after six months of mifepristone treatment. The studies will soon be published in a prominent journal, said Lawrence Lader, president of the Abortion Rights Mobilization in New York City, which supported the studies. Fibroids afflict 20 to 25 percent of women of childbearing age and are most commonly treated by surgery.

In early August, researchers at Stanford University Medical Center announced results of tests that showed mifepristone brought remarkably fast relief to people suffering from acute psychotic depression, for which the prior treatment was electro-shock. The FDA is fast-tracking approval, a first for a psychiatric drug.

Other encouraging medical studies are developing on difficult-to-treat diseases: endometriosis, ovarian cancer, breast cancer, prostate cancer, Cushing's syndrome, Alzheimer's and AIDS, said Jordan. Mifepristone may also have use as a “morning-after” pill or daily contraceptive. “If it weren't for the anti-abortion groups, it would a candidate for the Nobel prize,” said Jordan.

Cynthia L. Cooper is an independent journalist in New York who frequently writes about reproductive rights.

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