Outline
Thesis: RU-486, a very controversial drug first used in France, has been sparking debates in the U.S. ever since in was discovered in 1980. Now that it has been approved, many argue that this drug will mainstream abortion. However, others believe the approval of RU-486 is a positive decision and can greatly benefit women in the future.
I. Introduction
IV. Marketing and Distribution
V. Controversy over Abortion
A.) Current Controversy surrounding RU-486
1. Pro-life activists opinion
2. Pro-choice activists opinion
VI. Political Issues Surrounding RU-486
VII. Conclusion
Waiting eagerly for a decision from the Food and Drug Administration (FDA), pro-choice and pro-life activists rallied to voice their opinions on the drug mifepristone, also known as RU-486. However, the battle has just begun because RU-486, otherwise known as the abortion pill, was just approved for use in the United States on September 28, 2000. This controversial drug, first used in France, has been sparking debates in the U.S. ever since it was discovered in 1980. Now that it has been approved, many argue that this drug will make abortion more prevalent; however, others believe the approval of RU-486 is a positive decision and can greatly benefit women in the future.
RU-486, also known as mifepristone/misoprostol
To date, RU-486 has been responsible for more than half a million medical abortions in Europe (Mann, 2000). Mifepritsone is a synthetic steroid with anti-progestantional effects. The mechanism by which this works is the anti-progestantional activity resulting from competitive interaction with progesterone at progesterone-receptor sites. The end result of this competitive interaction is the termination of pregnancy (FDA, 200). Termination occurs because of a shortage in progesterone. The lack of progesterone will not allow the fertilized egg to adhere to the lining of the uterus. In order to expel the unattached egg, another drug, misoprostol, must be taken to induce uterine contractions; therefore, mifepristone is taken first and misoprostol is taken 24 hours later. Within hours the uterus breaks down and the pregnancy ends.
Before the drug was approved, many clinical studies were done and have shown it to be between 92-95.5 percent effective in causing a complete medical abortion. However, small percentages of women experience some complications with the drug. A study done on women in the U.S. showed that in 7.9 percent of the women (N=827), surgical intervention was necessary. Also, 1.6 percent needed medical intervention mostly for excessive bleeding, 4.7 percent had incomplete abortions, and 1 percent had ongoing pregnancies at the end of the study protocol. In French trials, a total of only 4.5 percent of women received surgical intervention, incomplete abortions, or ongoing pregnancy at the end of the study (FDA, 2000). Also, there are no data on the safety and efficacy of mifepristone in women with chronic medical conditions, women who are heavy smokers, or women who are more than 35 years of age and smoke more than 10 cigarettes a day. These patients were generally excluded from the clinical trials (FDA, 2000).
As a result of the clinical trials and other studies, the FDA requires that the patient should be given a copy of the medication guide and patient agreement. These require that each patient understand and sign a form that has information on what side effects can and probably will occur, in addition to other pertinent information regarding the drug. The side effects that most patients can expect to occur are vaginal bleeding and uterine cramping. Most bleeding or spotting lasts for an average of 9 to 16 days. Other commonly reported side effects include nausea, vomiting, and diarrhea. Rarely occurring side effects include pelvic pain, fainting, headache, dizziness, and asthenia (FDA, 2000).
In addition to the requirement of the patient agreement form, there are restrictions on who is able to use the drug. RU-486 can't be administered to women who are: suspected to have an ectopic pregnancy, have a intrauterine device (IUD) in place, are diagnosed with failure of the adrenal glands, need concurrent long-term corticosteroid therapy, have a bleeding disorder, or show a history of allergy to mifepristone or other prostoglandins. (FDA, 2000).
Besides the requirements that women must meet, there are also requirements that the doctor who prescribes the medicine must meet. Any prescribing doctor must be registered with the distributor of the drug, must agree with qualifications for use, and comply with its guidelines. Some of the guidelines are that the doctor must ensure the pregnancy be under 49 days duration, provide surgical intervention if needed, and also ensure that the patient has access to medical facilities for any problems that may occur. Also, the patient must have a 14-day follow up visit to confirm that everything is okay. The prescribing doctor must also report all ongoing pregnancies, serious adverse events, hospitalizations, and transfusions (Willis, 2000).
In addition to mifepristone as an early abortion drug, it also shows promise as a treatment for a wide range of serious diseases and conditions such as progesterone-dependent breast cancers, meningiomas, endometriosis, Cushing's syndrome, and possibly HIV virus (Feminist, 2000). Now that the FDA has approved RU-486 in the United States, people with these conditions may also have access to this drug.
RU-486 has been a greatly controversial topic ever since it was developed in 1980 in France. Looking back on the controversy over the drug one reporter writes, "The road toward FDA approval for the abortion pill RU-486, or mifepristone, has spanned two decades and has been cluttered with at-times bitter, contentious battles between those against abortion rights and pro-choice advocates"(Mann, 2000). A timeline of some of the milestones and roadblocks in the fight to approve RU-486 include:
1980 - Researchers in France develop mifepristone (RU-486).
1983 - FDA issues testing permit to Population Council to conduct trials of mifepristone as an early abortion method.
1988 - RU-486 is approved in France and anti-abortion rights groups protest.
1993 - President Clinton lifts a ban instituted during the Bush administration that prevents women from importing RU-486 for personal use.
1994-5 - French company gives Population Council in U.S. patent rights for RU-486 and clinical trials begin.
July 1996 - An advisory arm of FDA recommends approval of RU-486.
Sept. 1996 - FDA issues approvable letter but notes that additional information is needed on manufacturing and labeling before a final decision is made.
Feb. 1997 - The European manufacturer cancels its contract with Population Council, delaying the drug's introduction in the U.S.
1998 - Amendment is passed that bans FDA from using funds to approve any abortion drug. The Clinton administration opposes the amendment and the ban is deleted from bill.
Feb. 2000 - FDA postpones approval of RU-486.
Sept. 28, 2000 - FDA approves RU-486 as a method of early medical abortion.
Even with the FDA's recent approval, there are still some stumbling blocks in the road ahead for proponents of the drug, namely, the marketing and distribution of the drug. Danco Laboratories, LLC, New York, N.Y., is a tiny group of investors that formed to market RU-486. Although Danco plans to be the distributor of the drug, they may face problems in the future. Distribution of the drug could mean a profit of tens of millions of dollars for the company, but it also means possible protests and boycotts. This is why big pharmaceutical companies "won't go near it with a 10-foot test tube" (Lerner, 2000). This is also true for investors. Richard Hausknecht, medical director at Danco claims that potential investors are frightened to contribute money because of the possible problems it could cause with anti-abortion groups. Because Danco is so small they have been operating on a limited budget. This restricted budget could partly explain the reason for the long time it took for the FDA to approve RU-486. Along with marketing the drug, there has to be a manufacturer. The identity of the company, however, has been kept a secret. There are rumors that say it is a Chinese manufacturer, but Danco will not confirm or deny this. It is projected that Danco will see profits of about $34 million by 2004 given the $300 price tag for mifepristone/misoprostol (Blackman, 2000).
The outbreak in controversy over abortion began in 1973 when the U.S. Supreme Court legalized abortion, ruling that our constitutional right to privacy includes a woman's decision to terminate a pregnancy. Many people disagreed with this decision and have vehemently protested against abortion clinics and supporters. This dispute between pro-life and pro-choice activists has continued for over thirty years. Since the approval of RU-486 by the FDA, opponents and supporters both have said the debate may be changing, but the stakes are still the same (Austin, 2000).
This brings us to the current controversy between pro-life and pro-choice groups regarding RU-486. The pro-choice group believes that the decision to abort a pregnancy is to be made only by the woman; the state has no right to interfere. On the other hand, pro-life activists believe that from the moment of conception, the embryo or fetus is alive and imposes a moral obligation to preserve it. Neglecting to preserve the fetus, constitutes murder, in their opinion. The polarized labels for these opinions, though, "do not begin to accommodate the diversity of opinions which are actually held" (Long, 1992). The debate over abortion has been longstanding and the issues between the opposing sides remain the same. However, with the introduction of a new method for abortion, the issues are blown up once again and both sides feel threatened about what could happen in the future.
One anti-abortion public policy group is the National Right to Life Committee (NRLC). Olivia Gans, a spokeswoman for NRLC said after the FDA's approval of RU-486, "The reality is that we're still dealing with the death of a baby…the how, when or where of how that child dies doesn't really alter the nature of the debate. A baby is still dying" (Austin, 2000). Another argument that the pro-life group asserts is that mifepristone carries health risks for women who take it (Gottlieb, 2000). On the NRLC website there are many different articles that argue that RU-486 is unsafe. One of these articles includes information on women who have experienced major medical problems after using RU-486, and also a story on one woman who died after using mifepristone (NRLC, 2000). Douglas Johnson, legislative director of the NRLC, also argues that not only is RU-486 a public health issue, but also a human rights issue. Since the drug will be manufactured in China, Johnson says, "It is a public health issue because China is a major source of impure drugs -- and the FDA cannot possibly monitor a Chinese factory effectively. It is a human rights issue because Hua Lian Pharmaceutical is a major component of the Chinese government's population control program, which relies heavily on compulsory abortion" (NRLC, 2000).
The pro-life activists believe that they are absolutely right in their beliefs and they will go to many extremes to tell and show people that they are. One of the tactics that the pro-life activists have employed in the past is to stop women as they attempted to enter abortion clinics. They have also stood outside of the clinics and protested. Planned Parenthood has called these types of tactics a gauntlet of harassment. Gloria Feldt, president of Planned Parenthood, says that past victories for anti-abortion groups "have come from intimidation" (Austin, 2000). Now that approval for RU-486 has been issued, it will be harder for the anti-abortion groups to intimidate a greater number of providers spread across a larger geography. Although it may make protesting more difficult, the groups will still find a way to object to the FDA's decision. Randall Terry, the founder of the anti-abortion group Operation Rescue, aims to single out any doctor who prescribes the pill. Terry says, "We will expose him to the community so he'll no longer be known as a mom-and-pop doctor…He is going to be known as a baby killer" (Austin, 2000).
Not only are pro-life activists fighting against abortion because they think it's wrong, but some also claim that the new pill RU-486 could make abortion more prevalent. One pro-life reporter writes, "There's only one explanation for the action: Their hope is that, in the hands of primary care providers, the abortion drug combination will 'mainstream' abortion and end the public debate over abortion forever" (Willis, 2000). The group feels threatened because RU-486 provides an abortion in a more private setting instead of at an abortion clinic where everybody can tell what the woman is doing. They believe that this will lead to the end of the abortion debate since it will cause less attention to be paid to abortion. This lack of attention will eventually fade abortion out of the picture since they can't actively boycott a certain clinic. Because a woman can get RU-486 at the doctor's office, the protesters will not be able to dissuade women who choose to have an abortion.
Political Issues Surrounding RU-486
Although the approval of RU-486 might have set back anti-abortion groups, they vow to keep up the fight. Some of the ways they believe they can influence others is to elect an anti-abortion president who could overturn the FDA decision. In the current fight for presidency it is George W. Bush with whom the anti-abortionists side. Bush commented, "The FDA's decision to approve the abortion pill RU-486 is wrong. As president, I will work to build a culture that respects life" (Rubin, 2000). Anti-abortion rights groups believe that a Bush presidency could possibly reverse the tables on the favorable FDA decision or impose tighter restrictions on the drug. Heather Cirmo, a spokeswoman for Family Research Council, a conservative anti-abortion rights group who has helped lead the fight against the approval says, "the group would accept these restrictions as sort of a temporary compromise" (Twersky, 2000).
On the other hand, pro-choice activists support Bush's opposition, Al Gore, who believes something different. Gore said of the approval, "Today's decision is not about politics, but the health and safety of American women and a woman's fundamental right to choose" (Rubin, 2000). Pro-choice groups such as the National Abortion Rights Action League (NARAL) are taking no chances when it comes to the approval of RU-486. They see politics as a major influence on abortion issues, and this has proven to be true historically. The group is making a concerted effort to ensure that people see the approval as a political issue (Twersky, 2000). They believe that if Bush is elected it could be the end for early-option abortions by way of RU-486. A spokeswoman for NARAL says, "If Bush is elected, it could be the end of the day. We can't take that chance…Women deserve to have access to the full range of reproductive options" (Twersky, 2000). The group also contends that even though RU-486 has been approved, pro-choice Americans need to take the fight to the voting booth if they want to guarantee that the drug will be manufactured and distributed.
The pro-choice activists are also very driven when it comes to supporting a woman's right to choose. After the FDA's decision to approve the drug, Eleanor Smith, president of The Feminist Majority Foundation said, "I'm thrilled. It's a total victory for women. Politics was trumped by science and medicine...It's a breakthrough for women's health" (CNN, 2000). Some people also see the approval of RU-486 an advance in women's health comparable to the introduction of the birth control pill. They believe it is such a breakthrough because it provides another option besides surgical abortion. This allows women to terminate a pregnancy in its early stages, whereas in surgical abortion the fetus must be around eight weeks old. The fact that RU-486 provides an early option abortion is one of the pro-choice movement's most important weapons (Lerner, 2000). Surveys have shown that the American public finds early abortions more permissible than later ones. In fact, 65 percent of people accept first trimester abortion, but 69 percent oppose anything later than that (Blackman, 2000). In the past, the pro-life movement has focused on abortion procedures that take place in the second and third trimesters. With the introduction of mifepristone this has "shoved the dialogue back in the other direction" (Lerner, 2000). Pro-choice groups believe the dialogue is reversed because pro-life groups can no longer focus on the aborted fetus taking on the appearance of a small human being, potentially weakening the pro-life argument against abortions. The pro-life activists can no longer focus on the surgical aborted fetus having traits of a human being because RU-486 only allows the fetus to be 49 days old when aborted. Because of the early abortion time period the fetus appears as a clump of embryonic cells no bigger than a grain of rice.
Pro-choice activists argue that another positive aspect of RU-486 is the privacy that it offers to women. Instead of facing picketers and being called a murderer, a woman can go to her regular doctor's office, acquire the pill, and abort at home. Amy, a 35-year old woman who used RU-486 to terminate a pregnancy, was lying in bed with her husband beside her, rubbing her back when the cramps started. Amy said of RU-486, "The pill form allowed me to be in charge of the abortion. Privacy is a lot of it. I like to be able to do this on my own. I don't need doctors to be jeopardizing their lives. And I don't have to be jeopardizing my own life" (Lerner, 2000).
Pro-life activists think that the approval of RU-486 will cause abortions to become more common, but there's no evidence to support this claim. Abortion rates are the lowest they have been since 1978. Experts say that one big reason for the drop is a rise in family planning. Family planning includes practices of abstinence, contraception, and other birth control methods, such as the rhythm method. One expert said, "It's not that fewer people are having sex. Instead, we are doing a better job of family planning in this country" (Karras, 2000). Increased access to family planning tools has also contributed to the drop in abortion rates. Although this is good news to anti-abortion activists, they feel that the approval of RU-486 will reverse this trend; however, there is no data to support their predictions. In fact, there is data that supports the opposite of their theory. According to health officials in France, where the drug has been approved since 1989, researchers have found that the pill has not replaced surgery as the most common method of abortion and has also not increased the number of abortions (Rowland, 2000).
My stance on the approval of RU-486 most closely resembles that of pro-choice believers. I believe passionately in the rights of women and feel that the government should have no right to tell a woman what to do with her body. I also think that the approval of RU-486 will have positive effects on the woman's right to choose. Some of these effects will be the availability and early option of abortion, not to mention the privacy of the pill. Moreover, if a woman has a choice of using RU-486 over surgical abortion this could lessen the degree of psychological trauma that some women go through. If a woman is diagnosed early on in her pregnancy (before the eighth week), she has the option of using mifepristone and ending the pregnancy almost immediately. However, if a surgical abortion were the only option available, the woman must wait almost a month longer which could increase the psychological ramifications.
Although abortion seems prevalent in our society, there are no providers at all in 86% of U.S. counties, causing women to travel at least 50 miles for treatment. In places where clinics are available, they are easily targeted by anti-abortion groups 91 percent of the time. Although there are clinics available, doctors still see women who try to bring about a miscarriage by taking quinine pills, provoking boyfriends to jump on them, or coming into emergency rooms with electrical cords or hangers used as an abortive device (Blackman, 2000). To me, this is a great injustice. Women who feel that they are not able to terminate pregnancy in a safe way are in danger. With the introduction of the mifepristone, the availability of an abortion might become a more readily available option for women.
References
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