A Survey of Ethical Issues Regarding the Controversial Abortofacient RU-486
In recent years it has been hard for any American not to notice the attention the media has given to abortion and birth control related issues. We are bombarded with images of protests from every imaginable position, pleading coming from clergy both local and global, and even headlines about clinics being bombed. It is evident to every American that this may be a subject where the opposing sides never agree. One of the more recent debates has been over the abortion pill RU-486. This drug, also known as mifepristone, or commercially as Mifeprex, was originally developed in Europe by the French pharmaceutical company Rousell-Uclaf in 1980 (Raymond, 1991). It was designed to terminate pregnancy within the first 40-50 days after conception. It functions by binding to progesterone receptors and thereby blocks the binding of progesterone (Raymond, 1991). Progesterone is an important hormone for maintaining pregnancy. When it is blocked the uterine lining will detach and the embryo will not live (Raymond, 1991). A second drug known as misoprostol is then commonly used to induce uterine contractions and expel the embryo. After the creation of this drug and extensive clinical trials conducted both by Roussel Uclaf and various governmental agencies RU-486 was approved for use in France by 1989. In the following decade many other European countries also tested and approved the drug for use by the public. In America there was a different story. RU-486 was initially investigated by the FDA starting back in 1983. The Population Council and FDA conducted successful trials in Southern California in 1983. The World Health Organization reports mifepristone as safe and effective in study done in 1984. New England Journal of Medicine reports mifepristone as effective in 1993. FDA and Population Council conduct successful clinical trials again in 1994. The year 2000 arrives and the FDA still continues to review and evaluate RU-486 before final decision. Even 18 years later the drug has still not officially been approved. Why is this?
To answer the question of why RU-486 has had such a sordid history in our country you need to consider what makes America American. America has always considered one of its strongest points to be its diversity, in race, religion, values, culture, and opinion. It is this diversity that is also why America has not made a decision. American society cannot seem to agree on whether or not it is ethical to allow RU-486 to become available to the general public. Much of the disagreement has stemmed from the lack to factual information that has been made available to the general public. Interest groups on all sides of the issue along with the media have twisted, distorted, or selectively chosen information in order to support their particular agenda. While doing man-on-the-street interviews we discovered that most people do not know how RU-486 works, or even what it does. They often confuse it with the morning-after pill. They can only relate hearsay and rumors about the drug or what they heard on the news last night. It is this ignorance that leads to the controversy and conflict in society today. There are many different issues about RU-486 that interest the public. The most important and touchy subject though is the ethical considerations of the drugs approval. It was apparent that in this context that several key ethical questions need to be addressed if any progress is going to be made in the never-ending debate. The major points of ethical debate regarding RU- 486 concern abortion, safety and related policy, and the FDA’s approach to the drug’s approval, and the off-label use of misoprostol.
Briefly it should be stated what constitutes what is ethical and what is not. This in itself has been a much-debated topic down through the ages. However, rather than spend time discussing the myriad ways that philosophers have define ethics a simple set of conditions will be used to measure whether or not the actions or arguments are ethical. First, the major consideration for what is ethical is whether or not there is a risk to human beings because of the action or argument. Secondly, if there is a risk is the risk justified. Now I think that it is necessary to point out that the first consideration cannot be taken without the second. When discussing a pharmaceutical agent there are always risks involved. It is the relative amount of risk and justification that are the key points. As a common example, ibuprofen, the active agent in many types of pain medication, such as Tylenol, is considered by the most of the public to be completely safe. Though if one has watched in the media time and again you will see that studies showed that taking too much of this medication can cause serious liver damage, leading to death. So even here, what is considered mostly harmless actually has potential health risks involved.
It is perhaps impossible to discuss the ethics of an abortion pill without discussing the ethics of abortion itself. Abortion has become a taboo topic in America. It isn’t allowable to discuss it in the schoolroom and often not in the workplace. Many people are afraid to discuss their views on abortion because they do not want to be the target of radical activism which has been known to even go as far as murder. The basic point is that some people feel that abortion is perfectly acceptable and others view it as wrong and immoral. Looking specifically at the two major polarized groups, Pro-Choice and Pro-Life, that have taken prominence in American society we’ll see the justification of each for their viewpoints.
The Pro-Choice movement would describe that its first and only goal is to ensure the right of women to express their reproductive rights and freedoms (McLean, 1999). Pro-Choice does not consider itself Anti-Life or Pro-Abortion (Rudy, 1996). They consider abortion to be only one of the many choices available to a pregnant woman should she choose not to keep her child (Rudy, 1996). Focusing strictly on the abortion issues though they do not consider abortion an immoral act. The reason that Pro-Choice views abortion as a completely ethical procedure is because they do not consider the termination of an embryo to be the killing of a human being. Currently the mainstream Pro-Choice movement believes that an embryo does not exist as a human being until it has developed sufficiently that it can survive outside the womb (Rudy, 1996). This does not mean nine months necessarily as many premature births have shown. A human fetus can survive outside the womb beginning shortly after the beginning of the third trimester, though typically with severe complications. However this definition of human life has resulted in the banning of late pregnancy abortions in the United States.
The Pro-Life movement would describe thatits primary goal is to ensure the rights and freedoms of the unborn child (McLean, 1999). The Pro-Life movement considers abortion in general to be an immoral and unlawful act since it violates the rights of a human being (Smith, 1996). Pro-Life does not share the definition of life that the Pro-Choice movement does. Pro-Life considers the embryo to be a human being at conception and should likewise be granted that same rights and protection under the law that any other citizen would (Smith, 1996). However, Pro-Life does not consider the rights of the mother to be irrelevant but simply that there are two person’s rights at stake in determining the course of action.
More often than not the issue is not as black and white as these two groups or the media might like to portray it. There is a lot of middle ground where both groups can sometimes agree that abortion may be ethical (Sitaraman, 1994). If the lives of the mother and child are in immediate danger and it is likely that both might die, the decision to support abortion may be acceptable to both (McLean, 1999). If the child will be born with severe birth defects that would cause it to suffer and the chance of survival is low might also meet with acceptance from both sides (McLean, 1999). These are but two simplified examples of the gray area that often accompanies the complexities of real life and real people.
It is really impossible to make an absolute or objective determination whether abortion is strictly ethical or not. What is in question is the definition of human (McLean, 1999). What also is in question is whose rights are to be considered (McLean, 1999)(Blank, 1995). Considering the beliefs of each group, their ethical arguments are both justified. If the answer to these two questions could be agreed upon much of the debate I feel could be resolved between the two movements. The remaining problem though is that many of the finer points of the issue vary greatly between families, religions, and other social groups. There will never be a complete consensus amongst the entire American population.
The second crucial issue that the American public wants to know is the ethical implications of the drug based on its safety and the justification of current policy based on the actual safety. Based on all the current research available RU-486 is proven to be statistically safe and effective both in comparison to common surgical abortion and to similar pharmaceutical products (Raymond, 1991). Focusing exclusively on RU-486 as a pharmaceutical without regard to its purpose it is clearly ethical based on the current safety requirements from the FDA. Now clearly as for any drug there are those cases in which the drug has demonstrated adverse effects on patients and deaths have resulted from its use (Raymond, 1991). However, provided that this information is provided to those considering its use it is ethical for the drug to be allowed. The risks are justifiable as long as the patient is aware and understands them and is willing to face the consequences.
Based on the fact that from a clearly pharmaceutical standpoint the drug is safe much of the current policy regarding RU-486 is unfair and unethical. Through the late 1990’s the American federal government pushed to have RU-486 moved through the FDA process as quickly as possible because it had been deemed safe and effective. Prior to the Clinton Administration and in current Bush administration RU-486 has met with difficulties. The more conservative Republican Administrations have been tying up RU-486 in the FDA approval process because of their moral and typically Pro-Life viewpoints. Now this brings up several points that demonstrate clearly unethical practices. It is clearly unethical for the government to deny the public access to a drug on the grounds of safety when the drug has been clearly shown to be safe (Abraham, 1995)(Raymond, 1991). Whether or not the drug is moral is not the issue. The FDA is in charge of safety and the government has no right to twist or distort the information regarding its safety towards the public (Abraham, 1995). If the government wanted to pass a law banning RU-486 on moral grounds against abortion that is an entirely different issue. The point is that the FDA approval process is not a forum for a moral debate. Under the current law abortion is legal and therefore preventing the public access to a legal drug based on personal moral objections is discrimination and clearly unethical as it violates our constitution. In the end it is unethical for the government to use misinformation and stall tactics to prevent the pharmaceutical from approval since it has been shown to be safe.
Likewise during the more liberal Democratic government a different but related ethical question was raised. During the Clinton administration, RU-486 was placed on the fast-track FDA approval process. The issue is whether or not this is justified. Normally after a drug has been deemed as a candidate for the FDA it spends 8 years in the approval process (Lee, 1993). Much of this time is spent conducting joint safety trials between the FDA and the manufacturer (Lee, 1993). After the trials are finished the FDA spends on average 2 years in the review process before the final decision is announced (Lee, 1993). The fast-track approval process is typically reserved for special life-saving drugs that may help with conditions such as AIDS, cancer, and other debilitating diseases (Lee, 1993). It was developed so that drugs demonstrating significant benefit may be licensed on a limited basis to these individuals facing imminent loss of life without it. RU-486 is an abortion pill and as far as most people are concerned pregnancy is not a life threatening disease. So why exactly was the drug moved to the fast-track plan. Having an abortion pill available as an alternative to surgical abortion may in fact help prevent loss of life inherent in any invasive surgery. This would clearly be an argument for the movement as ethical. Unfortunately the more likely case is that after RU-486 having been held up in the previous administration because of its Pro-Life affiliation the Democratic administration which favors the Pro-Choice movement may have thought to turn the table and push it through as fast as possible to make up for lost time. Accelerating the drug through the FDA approval process is unethical for the same reason that stalling the approval process was. The FDA is not where the moral issues of our nation should be debated and battled over (Abraham, 1995). Giving the public misinformation and trying to go outside the normal lines is inherently dangerous. This is not something that we should allow our government to do. This is an unethical act because it demonstrates irresponsibility. If it had been or possibly may be later shown that RU-486 was dangerous it would have slipped by thousands of women could be at an unnecessary risk. This goes for any pharmaceutical. The FDA process is there to protect and inform the American people of the safety of our consumables and interfering in this process now only encourages tampering later and while RU-486 may have been safe the next drug might not be and how many people would suffer because of political agendas.
The final point of ethical debate moves away from the realm of the media and politics and returns to the realm of science and industry. A point of ethical debate that has become apparent in recent years is the use of misoprostol as a labor inducer. Misoprostol functions similar to the body’s natural prostaglandins, which leads to uterine contractions. As mentioned earlier this is used to expel the aborted embryo after mifepristone has performed its function. Now the debate stems from the fact that this was not the intended use for the drug. Originally, Searle Pharmaceuticals designed this drug for use in treating ulcers. However during the trials it was found to perform the other action mentioned. Some medical practitioners took advantage of this as a labor inducer for childbirth and it was used this way for several years. It must be noted that Searle did not sanction the drug for this use since no clinical trials for this type of purpose had been done for misoprostol. Eventually RU-486 was also used in conjunction with this pharmaceutical. Searle immediately upon hearing of this placed a warning on their product that it did not intend the drug for that purpose and it had not been tested accordingly. This brings up several points of ethical debate. First is that is it ethical for the drug to be used for a purpose it was never designed to perform. This is a major risk to the lives of the people using it as such. Now, as of yet it has not been shown that misoprostol presents any side effects that either occur in a high-percentage of cases or seriously endanger that life of the mother, in the short term. This would be an argument for its use as ethical, even though it would be a more Machiavellian method of proving its ethical nature. It has not been proven or disproved whether or not there are any long-term side effects using this drug in this way since it never went through clinical testing in this fashion which is the other side of the coin as an unjustified risk and unethical. This brings us to an ethical point concerning policy. For exactly the same reasons of risk as mentioned above, it can be argued that by using the drug for a different purpose than intended without testing it is similar to bypassing the FDA and the protective policy inherent in that office. Normally using a drug that has not been tested for a medical use is illegal in this country and those using it as such would face stiff penalties for endangering lives. However, since it had been approved for a different purpose this put it in a gray area of legality since this is a situation, which was not thoroughly accommodated by the FDA in their normal procedures. The fact that this is an issue with abortion only makes the situation more volatile. Once again this returns to political considerations. RU-486 has been recently approved by the FDA despite the power struggle between the opposing parties and for the FDA to pull misoprostol back into the approval process would set back into motion the horribly unethical battle of interest groups over both medications.