1/5/00 CHICAGOTR 8, 1/5/00 Chi. Trib. 8, 2000 WL 3623691
RU-486 REVOLUTION FDA POISED TO APPROVE ABORTION PILL
After years of vicious wrangling and political infighting between non-profit groups and pharmaceutical companies, abortion rights advocates and opponents, it appears that American women will finally gain access to "the French abortion pill.". On the eve of the drug's approval for market by the Food and Drug Administration, expected in January or February, abortion rights advocates already are celebrating the RU-486 revolution to come--and privately hoping that in the long run, the drug's availability will alter the debate over abortion forever. "America is on the brink of a historical moment," said Gloria Feldt, president of Planned Parenthood Federation of America. "Approval and availability of mifepristone (RU-486) will, I think, be comparable to the arrival of the birth control pill 40 years ago." For anti-abortion activists, the bottom line is clear: Medical abortion, induced by a drug, is still abortion. Still, they see that mifepristone could significantly redraw the lines in the abortion battle. "Mifepristone will absolutely make our battle harder to fight and harder to win," acknowledged Judith Brown, president of the American Life League. For the first time, American women will be able to elect to have a medical rather than a surgical abortion using mifepristone, in combination with another drug, misoprostol. Doctors who have participated in the clinical trials of mifepristone say the drug's availability will broaden women's choices, enhance privacy and make abortion safer by eliminating the need for a surgical procedure that requires anesthesia. Experience in countries such as France where medical abortion is legal indicates that most women will choose this procedure over surgical abortion, and that more women will have their abortions much earlier in their pregnancies because no waiting period is required. Finally, studies by the Henry J. Kaiser Family Foundation suggest there will be an increase in the number of doctors willing to offer non-surgical abortion services.
Abortion opponents fear these developments will blunt the highly emotional and politically explosive nature of the issue, leaving abortion rights advocates with a decisive advantage. "RU-486 could intensify the debate immediately, but the drug will have the long-term effect of muting it," said Kellyanne Fitzpatrick, a Washington-based Republican pollster specializing in gender issues. "It will reinforce the out-of-sight-out-of-mind libertarian attitude toward abortion, and take off the table the ability to show pictures of an unborn child and use anecdotes and be more public about what one group thinks is a private issue and another group thinks is saving a human life." Brown put it another way: "It further divorces the idea of motherhood, being with child, from pregnancy. Pregnancy will be viewed as a problem that can be easily taken care of." Medical abortion is neither a quick nor an easy alternative, doctors say. It is a multi-step process requiring screening, counseling and follow-up by a doctor in a clinic or medical office. Only after screening does a woman take the pill, followed by another pill 48 to 72 hours later that triggers a process resembling an early miscarriage. It is considered less traumatic to the body than surgical abortion, in which the uterus is emptied by surgery, an invasive and often painful procedure. Doctors participating in mifepristone clinical trials say women appear to be more comfortable with medical abortion from a psychological perspective, as well. "Mifepristone gives women a different method of abortion to choose from that allows her to undergo the process in a setting of her choosing with people she wants around, more or less timed for her convenience, in the privacy of her own home," said Dr. Paul Blumenthal, director of contraceptive research and programs at Johns Hopkins Bayview Medical Center in Baltimore. Mifepristone works by blocking the hormone progesterone, which is necessary to sustain a pregnancy. After the drug is taken, the cervix softens, the lining of the uterus breaks down, and bleeding begins. A few days later, the drug misoprostol is taken, causing the uterus to contract and expel an embryonic sac roughly the size of a grape, ending the pregnancy. The side effects of the drug regimen vary. Some women experience no physical discomfort, while others suffer symptoms commonly associated with menstruation and early pregnancy: nausea, vomiting, headaches and heavy cramping. All women will bleed, some lightly, others heavily, for one to two weeks. The risk of hemorrhaging, which requires a blood transfusion, is real but extremely rare.
Medical abortions have a success rate of 95 percent, according to data published from clinical trials conducted in 1994 and 1995 by the Population Council, a New York-based non-profit research group. Roughly five cases in 100 require follow-up surgical abortion because the action of the drugs is incomplete. Generally, however, medical abortion up to seven weeks into a pregnancy is considered safe with few complications reported, according to the council. Mifepristone has been tested for safety and efficacy and approved in 11 European nations, where an estimated 500,000 women have used it as an abortifacient. It is a medically simpler and safer procedure than surgical abortion and offers a key advantage: Women will no longer have to wait up to six weeks into a pregnancy for an abortion. Medical abortion is possible as soon as a pregnancy test is taken, and the earlier the abortion, Blumenthal said, the lower the health risk. Both sides of the debate agree that earlier abortions have greater public support, which may subtly alter the political landscape in favor of abortion rights activists, according to Cory L. Richards, vice president of the public policy division of the Alan Guttmacher Institute, a research organization that supports reproductive choice. National polls have shown that the majority of Americans support abortions performed in the first trimester of pregnancy. "(Abortion opponents) would argue that an abortion at two weeks is the same as an abortion at 22 weeks, but that is not how American women or the public at large sees it," said Richards. Both sides of the struggle also recognize medical abortion offers other political advantages, including the realistic possibility that thousands of physicians who now do not perform abortions eventually will begin offering the drug regimen. "Women often have to travel a long way down the pike, get child care and cross horrible picket lines to get an abortion," said Dr. Suzanne Poppema, director of Aurora Medical Services in Seattle and a participant in the mifepristone clinical trials. "Eventually women will be able to go to their internist or family doctor for mifepristone. It will mainstream abortion into regular medical care." Women, Poppema points out, will no longer have to undergo surgery at family planning clinics and offices that can be easily identified and targeted by anti-abortion protesters. But while some like Poppema believe the abortion issue will eventually be defused, others on the front lines are not as optimistic. They are bracing for possible product liability lawsuits, attempts by members of Congress to ban the drug, and continued pressure from the extreme wing of the anti-abortion movement. "Mifepristone will change the political debate, but it is not a panacea and it will not stop the violence," said Vicki Saporta,
executive director of the National Abortion Federation, the professional association of abortion providers. The fight to bring mifepristone to market has been bitter and protracted. Mifepristone was first marketed in September 1988 in France, where it was developed by the pharmaceutical firm Roussel- Uclaf. One month later, the company suspended distribution in the face of anti-abortion protests. The French minister of health ordered the drug back on the market, declaring it the "moral property of women." Roussel-Uclaf expanded the sale of the drug to the United Kingdom and Sweden, but announced it would not market it in the United States or any other country where its reception might be hostile. President Bush placed mifepristone on the FDA's list of drugs banned for import for personal use, an order reversed by President Clinton in January 1993. In 1994, Roussel-Uclaf donated the rights to the drug to the Population Council, which conducted clinical trials and applied with its licensee, the Danco Group, to the FDA for the drug's approval. While the FDA gave the drug a green light in 1996, the manufacturer of the drug, the Hungarian firm Gedeon Richter, backed out of the project a year later. With the Danco Group's new manufacturer now in place, the council expects its bid for final FDA approval to come early in the New Year.
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CASE STUDY 3 Background Jane Stevens, a 72-year-old Caucasian woman, presents to her GP complaining of upper back pain. She reports the pain has been slowly progressive over the past few years. However, recently she sneezed and the pain immediately intensified and was more sharp and localised. She thinks she may have pulled a muscle. A review of the patient's previous medical records rev