Asides the fact that there are inevitable side effects for any kind of pharmaceutical preparation there are two main aspects to be considered when we discuss the safety of the drug. The main contentious issue is that the drug was introduced without sufficient clinical tests in the U.S. In fact the approval was mainly based on the results of the drug usage from abroad and a single clinical test inside the United States. This has left room for skepticism about the urgency with which the government approved the drug. RU 486 was given an accelerated approval under the 'under 21 CFR 314 Subpart H' process. This is something, which is inexplicable as generally the accelerated approval is only meant for potentially life saving drugs whose side effects are overridden by the critical condition of the patient.
Mr.Brad Clanton, the counsel for the Judiciary subcommittee had this to say about the hasty approval of the drug under the 'Subpart H', "It's an accelerated process for approving drugs for people who are basically dying or are going to have some serious deformity if they don't get something [treatment] right away," "It was basically created for AIDS patients." He further adds, "If you look at the FDA's own medical review, it shows that RU-486 is much worse on every single side effect. It's obvious that it doesn't provide meaningful therapeutic benefit over existing procedures." This in spite of the FDA medical review, which found out that RU 486 "had more adverse events, particularly bleeding, than did surgical abortion." [Stephanie K. Taylor].
Further there is an important point which needs to be discussed here. The FDA, has only approved mifepristone while it has not approved the usage of misoprostol as a supplementary medicine. This is all the more important given the warning from 'Searle' the manufacturer that "Misoprostol is not approved for the induction of labor or abortion." So in the absence of a clear approval by the manufacturer the issue of the adverse reactions, due to the interactions of the different drugs inside the body, is yet unclear. The analgesics and the other complementary drugs that are prescribed further augment this problem.
While this is one side of the issue the National Abortionists Organization is bent upon making the drug more accessible to the women. In fact in 2001 alone there was a massive advertising campaign for which it spent around $2 million. Vicki Saporta, the executive director of the federation says '"The anti-abortionists are trying to frighten women with medical misinformation. They have been talking about how dangerous RU-486 is when, in fact, the trials show 12 years of safe and effective experience. We want women to have accurate medical information."[Gavin Yamey, BMJ]. So we see that there is no uniform consensus about the drug in the United States.
Arriving at a correct assessment of the drug as to its safety seems a really difficult proposition given the disparity in views between medical professionals. What we need is that our perceptions of the positive effects of the drug should not deter a through scrutiny of its negative effects. The working mechanism of RU 486 indicates that the drug is not essentially restricted to the uterus. Because RU 486 inhibits the action of the progesterone hormone it invariably affects the other parts of the body like the breasts and the nervous system. Furthermore chemically RU 486 is identified as a 'glucocorticoid blockers'. This means that they may affect the proper functioning of the adrenal glands, which directly indicates a susceptibility to infections. This chemical property assumes all the more importance in cases where the drug fails in its purpose and a surgical intervention is needed. (Surgery exposes the negative effects of glucocorticoid blocking function of RU 486).
When we have a quick look at the national scenario it is quite obvious that in spite of abortion being legalized (with restrictions) women are not having an easy time. In fact It is found out that 86% of the counties in the United States do not have a clinical facility for surgical abortion. This problem is only augmented by the radical actions of the anti-abortion groups, which have threatened and attacked the clinics that offer the service. Given this circumstance we can understand the significance of the pill. But still when we look at the whole process of chemical abortion, it seems that this method of abortion is not really a private, quick fix solution but instead it is a complex, time-consuming process.
RU 486 and the Abortion Choice (The Impact)
The pill is not a breakthrough at all but a rather laborious process wherein the patient is subjected to many tests before and after the treatment. There is no question of privacy as medical supervision is inevitable. The false propaganda of the drug being a totally private and problem less alternative to surgery is ill founded. Furthermore the stringent stipulations that the government has issued for the treatment means that it is not an easy procedure. In short, though the drug is a successful abortifacent it is not an off the shelf pill which a woman can use directly without medical intervention. Also the abortion process itself extends from a three days to a week alongside the bleeding, pain and other symptoms associated with it.
In a study conducted by the WHO in which 38 Australian women underwent Medical abortion it was found out that the outcome of the process was successful. Out of the thirty-eight women 25 considered Medical abortion as natural. However a similar test conducted in Britain on a sample of 353 women resulted in a different outcome with almost 26% choosing surgical abortion and 20% opting for Medical abortion. [Pam M. Mamers, MJA] So there is not a real shift towards medical abortion. The one main reason for the RU 486 pill not gaining the confidence of women is that it involves a great ordeal. The abortion process extends over a week as against the surgical method, which lasts only a few minutes and a couple of checkups. [Pam M. Mamers]
The moral or the ethical aspects of abortion depends a lot on how we understand the underlying differences between abortions performed under different time periods. We are confronted with two main issues. Firstly we have to decide upon the status of the fetus or what is called the moral status of the baby. Another important consideration is the right of the women over the life of the innocent baby. Invariably all our ethical and moral reasoning revolves around these two important points.
The Politics behind RU 486
The introduction of RU 486 has been mainly viewed as a political duel especially under the circumstances in which the FDA approved the drug. (When election was due). The republics and the democrats were split in their views. While the democrats proclaimed the pill to be a rightful solution providing for a safe, secure, and private abortion method for women the republicans argued about the moral and ethical unacceptability of the drug. If we set aside the moral and ethical issues involved and look from a medical point-of-view RU 486 has certain advantages.
The main argument in favor of RU 486 revolved around the fact that it offers women the best and early way out of pregnancy in their own privacy. But after a careful study of the procedure it is now plainly obvious that RU 486 is still not a self-help drug and it requires intervention from the physician. So from the women's point-of-view RU 486 is not a real breakthrough. But the democrats argue that abortion pill offers women a chance to escape the intimidation that is usually involved in the surgical abortion process. As the democratic representative Jerrold Nadler says "Mifeprex makes it easier to avoid the terrorization by the thug elements of the anti-choice movement in this country who have used every opportunity to terrorize doctors and women," [Jeff Levine] While there may be some truth in this argument the issue of privacy still remains a unattended concern.
The republic party has its own views on the matter. Tom Coburn republican representative and a physician said, "The character and the integrity of the Food and Drug Administration has sunk to a new low today. Not only have they spent time trying to figure out how to deal death to an unborn child, what they have done is violate their own code of ethics." [Jeff Levine]. We see that the abortion issue has become more of a political spotlight in the recent years. But what we are missing out is that our deliberations on this subject of RU 486 mean little in terms of the moral and ethical aspects of accepting abortion itself. In the first instance many physicians consider the battle against RU 486 as grossly mistaken and misdirected effort against abortion itself. As Mr. Arthur Caplan, Ph.D. says, "I think fighting over abortion technology is…