RU-486 safe and effective?

The president of the Australian Medical Association has gone on the record as stating that the administration of RU-486 to pregnant women is a safe and effective means of procuring an early pregnancy abortion. However, it is questionable that this product is either safe or effective.

The issue is in the news because the Australian Democrats, who are represented in the Australian Senate, plus the Greens and a few others are pushing for the relaxation of the current import restrictions on this particular drug. At the present time the Minister for Health (Mr. Abbott) has to give the final approval for the importation of the drug as well as the purpose for which it is to be used. The trials relating to the treatment of endometriosis, as well as those relating to the treatment of women's cancer, including breast cancers, are not the issue regarding the safety and effectiveness of this drug.

The proposal of the Greens and Democrats is that the authority that is given to the Minister for Health should be removed from that Minister and given to the Australian Food and Drug Administration, thus allowing for a decision to provide RU-486 to women who are in the early stages of pregnancy.

This proposal is tainted because it is based upon the false premise that the drug is a safe and effective method of procuring abortion for pregnant women. Having read some of the results from the trials in the United States and elsewhere, one has to wonder how anyone can jump to the conclusion that RU-486 is a safe and effective drug for any woman to use. It has a very high level of toxicity, and at least 5 deaths have been associated with the use of this drug.

The safety of RU-486 is extremely debatable when one considers the contraindications for use. The manufacturer has advised that there are some circumstances where it is unsafe for use, including high blood pressure, smoking, and risk of blood clotting. What is alarming, is that one of the victims of RU-486, was an 18 year old who was left to bleed to death. (I will be covering the case of Holly Peterson in this blog.)Also, what is being ignored is the fact that the first part of the RU-486 treatment, which is the anti-progesterone component of the treatment has only a 60 per cent rate of effectiveness. The second phase is that of the stimulation of the womb to contract and expel its contents through the use of prostaglandin. This is a treatment that is not only less than effective, it also responsible for the deaths of at least 5 women, plus severe injury to countless other women.

If I was to compare the safety of RU-486 against the risks of taking the cox2 inhibitors, such a Vioxx, I must admit to being perplexed as to why it is that there is not an outcry, or even a large number of class action lawsuits against the manufacturers of RU-486. In the case of Vioxx, trials were carried out, where people were given higher than the normal dose, for use other than for controlling inflammation within the body. As a result of this trial, the drug was pulled from the market since there were questions being raised about its safety, (even though millions of people had been benefiting from its use over a period of years). As a result of that action, class action lawsuits have been raised in the USA and elsewhere based upon the allegation that the manufacturer gave insufficient warning about the possible effects upon one's heart. The first lawsuits have related to the deaths of some people who had a heart attack and died. The first jury decision went against the company, yet I believe that the jury was wrong to have made that decision. There was no evidence that his death was in fact related to the use of Vioxx. The same is true for the latest case in Florida where the man had a heart attack one month after starting Vioxx. Personally, I doubt that there is a link to the Vioxx because one month is not long enough to have had any form of reaction. It must be remembered that people with arthritis have a tendency to have problems relating to the heart muscle due to the nature of the disease. Now, in the case of RU-486 we have the same problem in that there is a claim that it is safe, when in fact there are serious questions to be raised about safety with regard to both the physical and mental health of a woman. It does not make sense to contemplate allowing something that is so dangerous to the health of a woman onto the Australian market.