Download Ethics of RU-486

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 that its 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 RU486 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.
Ethical debate over abortion in general, the current public policy, or moving the
drug to fast-track process is just the tip of the iceberg. There are a thousand ethical
considerations over something as controversial and emotionally charged as the RU-486
debate. From what has been discussed here the disagreement stems much from differing
opinions over definitions and protection of the rights of the involved parties.
Unfortunately these opinions regardless of their ethical justification have influenced our
government to involve itself in the controversy in an unethical manner. The only truly
ethical thing to do in light of all of this and what I believe most American people really
are after is for the parties involved to relate to them factual information, present their
arguments and concerns, and let the American people decide for themselves individually
whether or not they wish to use the drug and accept all of the risk and consequence that
goes along with that decision. After all America was founded on our intrinsic right to
choose for ourselves how we will live our lives. Looking to the future this is a crucial
debate, perhaps not so much because it is an abortion issue but because it is a
pharmaceutical issue. As technology advances the pharmaceuticals and even other
medical technology we develop will affect other parts of our lives in ways that may incite
more heated debate than even abortion. How we handle our response to RU-486 now
will be a standard for our conduct in the future. If we mishandle this now our faults may
come back to haunt us later when a lot more will be at stake.
References:
Abraham, John. Science, Politics and the Pharmaceutical Industry. UCL Press, London.
1995.
Blank, R., Merrick, J., Human Reproduction, Emerging Technologies, and Conflicting
Rights. CQ Press, Washington D.C., 1995.
Lee, Chi-Jen. Development and Evaluation of Drugs. CRC Press, Boca Raton, Fl. 1993.
McLean, S., Old Law and New Medicine. Rivers Oram Ltd., London, 1999.
Raymond, J., Klein, R., Dumble, L., RU-486: Misconceptions, Myths, and Morals.
Institute on Women and Technology, Cambridge, MA. 1991.
Rudy, K., Beyond Pro-Life and Pro-Choice. Beacon Press, Boston, 1996.
Sitaraman, B., The Middleground: the American Public and the Abortion Debate.
Garland Publishing, New York, 1995.
Smith, D., Life and Morality. Gill and McMillan Ltd, Dublin, 1996.
Disclaimer: As far as was reasonably possible the author of this paper kept all personal
consideration, including political, religious, or other influences our of the article. This
paper was intended to be objective as possible. If that goal was not achieved, I apologize
for any remark that was made out of context or seemed unreasonably biased.