Article On Ru 486 Essay, Research Paper

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The Medical Uses of Mifepristone

In addition to its use in terminating unwanted pregnancies, MIFEPRISTONE (formerly known as RU-486) also may be effective in treating a range of serious diseases and medical conditions, many of which particularly affect women. Yet American clinical trials for most of these uses have come to a standstill due to anti-abortion politics.

A B O R T I O N & F E R T I L I T Y C O N T R O L

Available to women in many countries (but currently not in the U.S.), mifepristone (formerly known as RU-486) is the first in a new generation of fertility control agents that can terminate an early pregnancy. Mifepristone works by blocking the action of progesterone, which is necessary to sustain a pregnancy.

Mifepristone, taken along with a prostaglandin, has been used by over half a million women worldwide and has found to be safe and effective as an early abortion method during the first nine weeks of a pregnancy.

A woman can take mifepristone as soon as she knows she is pregnant. Mifepristone is administered orally, is non-invasive, requires no anesthesia, and bears less risk of infection. Many women prefer mifepristone because the procedure is more private and allows them greater psychological control in ending a pregnancy. Administered with a single dose of a misoprostol (a prostaglandin given as orally or as a vaginal suppository), mifepristone has been proven to be highly effective in successfully terminating pregnancy.[1]

Studies also show that mifepristone is a safe, effective post-coital contraceptive.[2] [3] Preliminary shows show, as well, that mifepristone can act as both a male and female contraceptive.

[1] Spitz IM, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. New England J of Medicine, 4/30/98.

[2] Baird DT, Dewar M, Glasier A et al. Mifepristone (RU486) compared with high-dose estrogen and progestogen for emergency postcoital contraception. New England J of Medicine, 10/8/92.

[3] Bygdeman M, Danielsson KG, et al. Contraceptive use of antiprogestin. European J of Contraception and Reproductive Health Care, 6/99.

many women report feeling “less guilty” about medical abortion. some even say it feels more like bringing on a late period or taking the morning-after pill than having an abortion.

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VOICE: AUG 30, 2000

Western medicine’s first approved nonsurgical abortion method, RU-486?which is also known as mifepristone?is in many ways a successor to the teas and tinctures women have used for centuries. (For a look at an underground abortion drug, see “The Star Pill.”) When taken with misoprostol, an ulcer medication that’s already approved and available in the United States, RU-486 blocks the hormone that gets the body ready for pregnancy; within hours after a woman takes the two pills (one 24 hours after the other), the lining of the uterus breaks down and the pregnancy ends. But, because it works from the very earliest stages into the seventh week, many see RU-486 as a method that can prevent pregnancy from beginning?a distinction that could prove huge. For women who have taken it, RU-486 often sidesteps the stigma of having an abortion; a pill, many of them say, feels more natural and less invasive. Most doctors, too, seem to be more willing to prescribe a medication than to perform a surgery, however minor.

That’s certainly been the case in France, where some 25 percent of abortions are now done with RU-486, which is widely available in French doctors’ offices. France, it should be noted, is not some sort of women’s rights mecca, where toilet seats are welded down and tampons are free. The country has its own history of strife over reproductive rights, its own bands of zealots bent on forbidding abortion at all cost.

In fact, a few such abortion opponents were at the helm of Roussel Uclaf, the very company that developed RU-486 back in 1980. (1980!) In late 1989, two years after the safety and efficacy of the drug were established in French clinical trials, these executives?as well as the Roussel’s head of security, who was recruited into the effort because of his strong antiabortion beliefs?tried to overpower their pro-choice colleagues within the company and force Roussel to abandon the drug. The antiabortion faction of the company had already written a press release announcing the decision, when an 11th-hour countercampaign saved the first major abortion breakthrough from oblivion. A petition with more than 2000 signatures and a flurry of press coverage quashed the anti-RU-486 rebellion. Despite political opposition, the French minister of health declared RU-486 “the moral property of women.” By April of 1990, the drug was on the French market.

1999: Mifepristone is approved in Switzerland, Austria, Belgium, Denmark, Spain, Finland, Greece, Germany, the Netherlands, and Israel. The Population Council and Danco, a group of investors formed to market mifepristone, submit the requested information to the FDA. Approval is widely expected by early 2000.

2000: February?The FDA issues another approvable letter for the use of mifepristone in early abortions, but says more information is still needed. June?The Washington Post reports that the FDA is considering approving mifepristone with stringent restrictions. The agency sets another approval deadline for September 30. July?Representative Tom Coburn’s amendment to an agriculture appropriations bill, which would forbid the approval of mifepristone, is voted down. September 30?By this date, if it holds to its schedule, the FDA will have approved, rejected, or requested still more information about mifepristone.

TIME: THE ABORTION PILL

OCTOBER 9, 2000 VOL. 156 NO. 15

In the meantime, abortion has become steadily less available in the U.S. There are no providers at all in 86% of U.S. counties; 91% of abortions occur in easily targeted clinics, and 1 in 4 women has to travel at least 50 miles for treatment. Doctors still see women who try to induce miscarriage by taking quinine pills, or provoke their boyfriends to jump on them, or come into emergency rooms with electrical cords hanging out of them.

Since 1988, when mifepristone was first approved in Europe, abortion-rights activists have fought to introduce it to the U.S. as the first alternative to surgical abortion. The FDA under President Bush banned its import in 1989, citing safety concerns. On his third day in office, President Clinton lifted the ban and ordered the FDA to begin safety testing. Developer Roussel Uclaf, meanwhile, sick of getting hammered by both sides, donated U.S. patent rights for mifepristone to the Population Council, a nonprofit reproductive-rights group founded 50 years ago by John D. Rockefeller. The council had to steer the drug through U.S. trials, file the applications for approval, weather the political storms and lawsuits that followed every step of the process. No wonder it took nearly eight years.

Even advocates who had been hoping for this ruling for years were surprised at how few restrictions came with it. Though the agency had ruled mifepristone “safe and effective” back in 1996, it took four more years to find an acceptable manufacturer and figure out distribution. Last summer the FDA hinted that it was thinking of playing very tough: that only doctors who currently do surgical abortions would be allowed to prescribe mifepristone; that there might be some special certification required, or a rule that the doctor have access to an emergency room less than one hour away. All of that would have made the approval of the pill almost meaningless; abortion would still be unavailable in vast swaths of the country.

But last week’s ruling said that to prescribe the drug, a doctor must be able only to date the pregnancy conclusively and, if anything goes wrong, provide surgical intervention, either to complete the abortion or to stop heavy bleeding. “All this says is that physicians prescribing this should be good doctors,” says Dr. Wendy Chavkin, an ob-gyn at Columbia School of Public Health. In 1998, when the Henry J. Kaiser Family Foundation polled family practitioners about their interest in using mifepristone once it was approved and available, 45% of doctors responding said they were “very” or “somewhat” likely to use it–even though only 3% of them had performed surgical abortions.

But at the time of the survey, the drug was still crawling through the approval process. Now that it has been cleared, the real test begins. A doctor’s decision to offer the drug rests on a complex calculation. Many may read the FDA language about the pill’s being limited to “physicians who can accurately determine the duration of a patient’s pregnancy” to mean that they should do this with ultrasound–and most do not have ultrasound equipment in their office. Likewise, special training and extra malpractice insurance might dampen enthusiasm for offering the drug. Doctors will have the extra burden of locating those women who do not return for the final visit to make sure their pregnancy has been terminated. Were there to be an increase in complications or birth defects associated with mifepristone (none have yet been reported), insurance companies would probably adjust their rates accordingly.

And even though mifepristone has won federal approval, the current patchwork of state laws still applies. Some states require any doctor who performs abortions to register with the state and report every procedure he does. Some have rules about the design of offices where abortions occur or require that the fetal remains be examined by a doctor. In North Dakota, the law requires that remains be buried or cremated.

Apart from the logistical and legal hurdles, there are the moral and psychological ones. Doctors who don’t do abortions on principle are not likely to change their mind based on the method. Those who approve of abortion under certain circumstances will still want to see how mifepristone works, how widespread its use becomes and whether a backlash could endanger their entire practice. Dr. Thomas Purdon, president-elect of the American College of Obstetrics and Gynecology, spoke with a lot of his colleagues last week after the news broke and found them both receptive and cautious. “The medical abortion is less traumatic and done so much earlier in a pregnancy that physicians can rationalize the fact that they are not disrupting a more advanced pregnancy,” he said. “The emotional and ethical barriers are easier to cross.” MORE**