Predicament of the pill

It only takes a few doctor's appointments and a couple glasses of water.\nBut the implications of the abortion pill might be much more difficult to swallow.\nThe Food and Drug Administration approved mifepristone, formerly known as RU 486, Sept. 28, giving American women the first opportunity to terminate a pregnancy without surgery. It has been distributed in France for more than 10 years and will be available to U.S. women in about a month. The United Kingdom and Sweden are among other countries that have approved mifepristone.\nWith the abortion controversy one of the most emotionally charged issues in America, both sides of the dividing line are questioning the impact a decision like this could have.\nAlthough anti-abortion advocates plan to fight the FDA's decision, many believe RU 486 will not alter the controversy much.\n"I don't think it's going to affect it greatly," said Michael Fichter, executive director of Indiana Right to Life. "The surgical abortion will not go away. RU 486 is just another element in the mix."\nSylvia Johnson, media coordinator for Planned Parenthood of Greater Indiana, said she agreed the FDA's decision won't intensify the clash between anti-abortion and pro-choice supporters.\n"It's the same," she said. "We are going to continue to support her right and we're going to provide her that right."\nDanco Laboratories, the drug's manufacturers, told providers of mifepristone they would receive the drug within 30 to 60 days, Johnson said. The Indianapolis and Bloomington Planned Parenthood clinics will be the first to administer the drug in Indiana. The northwest location in Merrillville, the only other Planned Parenthood abortion clinic in the state, should receive the pill later in the year, Johnson said. The IU Health Center will not distribute Mifeprex, said Director Hugh Jessop.\nDanco will set a price for the product, Johnson said, but Planned Parenthood clinics will try to make the cost of mifepristone comparable to the $325 of a surgical abortion.\nFrom plan to pill\nIn 1994, the French manufacturer Roussel-Uclaf donated rights to the drug to the Population Council, a nonpartisan research organization that deals with reproductive heath and population growth. Clinical trials of 2,121 women in 15 states were conducted from September 1994 to September 1995, and an application for approval was submitted to the FDA in 1996.\nAfter the FDA's Reproductive Health Drugs Advisory Committee agreed in 1996 that mifepristone's benefits exceeded its risks with a vote of 6-0-2, discrepancies in labeling and distribution delayed final approval. The Population Council awarded Danco Laboratories as the sole authority to manufacture and distribute mifepristone under the name brand Mifeprex. \nHow it works\nMifepristone is intended for women in the early stages of pregnancy -- the latest a woman is recommended for the drug is seven weeks after her last menstrual period.\nAfter ultrasound confirms the pregnancy, mifepristone is taken to block the hormone progesterone, which loosens the lining of the uterus and causes bleeding. At a second appointment two days later, the second drug misoprostol is taken to cause contractions and complete the abortion. About two weeks after the second visit, the patient returns to make sure the pregnancy has ended.\nHeavy bleeding is a common side effect and usually lasts about nine to 16 days. In the trial, four women required blood transfusions for severe bleeding. About one in 100 women needs surgery to correct heavy bleeding problems. Cramping and nausea are other common side effects.\nDespite adverse side effects, two-thirds of women in the study who reported different experiences from what they expected believed the procedure was better than expected. One-third said it was worse. About half said the pain was not as intense as they originally had thought.\n"For most women, they said the pain wasn't as bad as the fear of the pain," said Christina Horzepa of the Population Council. "The pain is part of the process."\nBefore the abortion, the woman must sign an agreement stating she will return to her doctor for the scheduled visits, she understands the possibility of the procedure not working and is aware the abortion could be completed by surgical procedure.\nIn women with pregnancies of 49 days or less, 92 percent of abortions were successful. Five percent had incomplete abortions, and in cases such as those, the option to have a surgical abortion must be available to the patient. \nThe pill providers\nA stipulation for doctors and health care providers supplying Mifepristone requires them to refer patients to a provider who can perform a surgical procedure or be able to do it themselves. The provider also signs an agreement form from the distributor, agreeing to be able to provide patients with further medical treatment and to report any non-terminated pregnancy or hospitalization to Danco. \nAlong with the access to surgical procedure, the FDA sets guidelines for all mifepristone providers. They must be able to assess the duration of pregnancy and recognize ectopic pregnancies, when the fertilized egg is implanted and begins to develop in an area other than the uterus.\nUnlike other medications, mifepristone will not be available in pharmacies. Physicians will dispense the drugs in their offices, whether they are abortion providers or not. \nExpectations about how many more health care officials will begin providing abortion pills are speculative and have fallen on both sides. Some believe the number will definitely increase, such as IU-Purdue University Indianapolis law professor David Orentlicher, former director of the American Medical Association's Division of Medical Ethics and co-director for IUPUI's Center for Law and Health. Although he said he thinks more doctors will request access to mifepristone, questions doctors will ask themselves will weigh into their decisions, he said.\n"Some people don't believe in abortion, so a lot of obstetricians don't do abortion because they think it's morally wrong," he said.\nPersonal safety also crosses the mind of physicians, he said.\n"It's going to be harder to find out who's providing," he said. "If that's a possibility, their names will become publicly available. They have to worry about harassment."\nHealth care officials choosing to administer the drug will not face new circumstances totally foreign to them, Horzepa said.\n"(It's) treated as if you were having a natural miscarriage," she said. "You would go in the rare case where there are severe side effects. The treatment would be the same -- it's not like this whole procedure has not been encountered before by the medical community."\nSimplicity vs. surgery\nReactions by women who participated in the trial were positive, even by those whose abortions were not completely terminated by the drug.\nAbout 96 percent of women in the clinical trial would recommend it to a friend -- and among women with failed abortions, 70 percent would recommend it. \nAbout 92 percent would choose this method again; 85 percent of women with incomplete procedures agreed.\nBut this finding does not necessarily mean the number of abortions in the United States will increase.\nHorzepa said the trial's results were "right in line" with the French trial outcome. In France, the number of abortions performed with RU 486 did not increase -- they decreased. And the proportion of surgical abortions to medical abortions, or those done without surgery, was about one-third medical and two-thirds surgical.\nShe said many women chose the surgical procedure because it was quicker -- there was no waiting or threat of failure. With the drug's intended use in the early stages of pregnancy coupled with France's weeklong waiting period before the procedure, women might choose the surgical method.\nFrance and the United States are different in many aspects, making assumptions even more unclear.\n"I think time will have to tell," said senior Shannon Goings, president of Students for Life. "I'm not sure because the climate here is different from Europe."\nAlthough some women might consider medical abortion safer because it is considered noninvasive, Horzepa said "the truth is the surgical is very, very safe."\nA woman's decision to have an abortion is often based on deep-rooted personal convictions, so the approval of a new drug could prove to have no influence, Johnson said.\n"It won't have any impact on a woman's decision because she'll (give) the same amount of thought," she said. "She'll just know she has an earlier option"