RU 486 - Miracle or Curse?

J.C. Willke
Reproduced with Permission
Life Issues Institute, Inc.

RU-486 is the well-known French abortion pill. Before discussing it, let us first review female physiology a bit.

There are two female hormones. One, is estrogen. When this hormone is produced, the girls body turns into a woman. It shapes her body and develops her breasts. When this hormone leaves, she goes through "change of life." It is one of the two reproductive hormones.

The second hormone is progesterone. This is sometimes called the pregnancy hormone. It is produced in a cyclic fashion in the second half of every month. There isn't much of it produced in the first half of her menstrual month, then there is a substantial amount of it produced. The function of this hormone is to thicken and prepare the lining of the womb for the nesting of a new embryo. If that month she is pregnant, production of this hormone increases markedly and is maintained throughout the pregnancy. It can properly be called a nutritive hormone. If she does not get pregnant that month, then this hormone is withdrawn and the lining of the womb sloughs in what is known as menstruation.RU-486 blocks the action of progesterone.

Its action could be compared to a grape on the vine. If you were to pinch the stem so as to prevent the nutritive sap from getting to the grape, then the grape will wither, die and drop off. Essentially this is what is done when this pill functions to end a pregnancy. It deprives the developing embryonic baby of this vital nutrient hormone, progesterone, and so this tiny one withers, dies and is lost, along with the lining of the womb which is not maintained because of the blocking of this hormone.

It is important to emphasize that there is only one scientifically proven function for this pill. That is to kill a developing baby after his or her heart has begun to beat. This pill is not a contraceptive. It does not prevent the release of the fertilized ovum. This pill may function as a morning-after pill although experiments continue on this and nothing has yet been proven. It has been tried as a once-a-month pill and has been found to be ineffective and totally rejected by the women on whom it was tried. I'll discuss its potential therapeutic functions, but it is important to repeat there is only one proven function for this pill, and that is to destroy the life of an embryonic baby after his or her heart has begun to beat.

There is only a short window in time during which this pill is effective in destroying an embryonic baby. If we count from the first day of the last normal menstrual period, four weeks have elapsed when her period is due. The fifth week, she does not yet go to a doctor, as she could simply be late for her period. The earliest a woman goes to the doctor is at the end of that fifth week. This pill works only in the sixth and seventh weeks. After that it becomes progressively more and more ineffective. In France, it is only given in those first seven weeks, which means, only during that two week window. In the United Kingdom, it is being given in the first nine weeks. Translated that means a four week window in time. There is substantial evidence to indicate however, that the further into pregnancy, the less effective the pill becomes.

The major study in the U.S. in the spring of 1998 reported a 92% effective rate of abortions, if used within that two week window of time. In the next week (8th week) it was 83%, and in the 9th week it dropped to 77%.

If used alone in those first few weeks, if she is pregnant and if every thing else is in order, studies have shown that from sixty to eighty percent of the time it will be effective in killing that embryo and ending the pregnancy. This is not effective enough for the pill to be used as a major drug on the open market. Therefore, it is almost always followed by a second drug.

Prostaglandin is a hormone that produces contractions of the uterus. It produces violent labor and delivery of whatever size baby she carries. Accordingly, most of the time prostaglandin is added after the pills have been taken. When used together in the first 7 weeks, as noted, 90 to 95% of the women abort. The prostaglandin used is an oral form Cytotec or Misoprostol.

There remains however, five, some studies report eight or ten percent of the women who still do not abort. The answer by the abortion folks is that she must then have a surgical scraping out of her womb, a surgical abortion, for if she carries that surviving baby to term there is a substantial risk of fetal deformity.

Let me take you through the clinical routine that has been established in France for the use of this pill. It is a very tightly controlled clinical situation, quite unlike medical practice in an open clinical setting, such as one would find in most nations. But let's be that woman who goes to the clinic in France and wants to use this pill. First her history is taken. A complete physical examination is done plus apregnancy test. Assuming her pregnancy is confirmed and it is within that window of time, a complete blood count is done. If she is anemic the pill is not used. Then she is asked a series of questions, if she has any of the following problems she will not get the drug.

Is she a smoker? Sorry! No pill. Does she have circulation problems, asthma, high blood pressure, fibroid tumors on the uterus, glaucoma, (that is increased pressure in the eye), stomach ulcers, colitis, (inflammation of the bowel), is she anemic, does she have infection of the female organs, has she had a recent caesarean section? If she says yes to any of these, she is not given the pill. Finally, it is usual to give an ultrasonic exam to confirm that her pregnancy is in the womb and not a tube and that it is not too far advanced for the pill to work. She then is given a paper to sign. This is a legal release form and is very interesting because of one section. This section says, that she agrees to take the pill, and after that will accept the prostaglandin drug, and if she does not abort she will then submit to a surgical abortion. It states that if she fails to abort from the drugs, but then refuses to have a surgical abortion, she then goes on to have her baby, if the baby is deformed, she will not enter into a law suit against the company.

French law requires a waiting period of one week. She then returns to the clinic, swallows the pills in the presence of the doctor and departs. She returns for a third visit. If she has passed baby parts she must collect those parts in a jar and bring them to the clinic for examination. If she has not aborted, she is then given the prostaglandin drug, Cytotec, and kept in the clinic for the balance of the day. Fifty percent abort by late afternoon. The rest are either taken into the operating room and a surgical abortion is done or they are sent home.

She returns for the fourth visit, and has a physical exam. If all is well, this may be her last visit. But it very commonly is not, for a variety of reasons. The major reason for additional return visits, is continued, prolonged and heavy bleeding. Typically she will bleed from ten to as long as forty days. In the largest study out of the United States, published in The New England Journal of Medicine, one woman in every 100 bled so long and so much that she needed to have her womb scraped out to stop the bleeding. In a recent large study in the United Kingdom, one woman in every hundred needed a bloodtransfusion.

Other problems? Yes, pain was a constant major problem for women, with one in four needing narcotic injections for the pain. Nausea and vomiting are also a constant pattern here.

But the big one is death from heart attacks.

The French company has admitted to one woman who died from a heart attack after having had these drugs. They also admit to two other near deaths. One of these was a cardiac arrest, the other was a ventricular fibrillation. The answer to cardiac arrest is to start the heart back. The only way to do that is by electric shock, with a machine called a defibrillator. It so happens that this lady's heart stopped while she was in a clinic equipped with this very technical piece of equipment. They shocked her, started her heart back and she lives. But, if she had been anywhere but that clinic she'd be dead. The second lady, had a ventricular fibrillation which is a rhythm disturbance of the heart in which the heart quits pumping and the muscle just quivers. That is quickly fatal unless the proper rhythm is restored. The only way to restore it is by electric shock by a defibrillator.

Fortunately, for both of these women they were in a technically equipped clinic. If they had been anywhere else they would have been dead. These were out of the first 80,000 abortions done in France. If we assume that the two ladies would have died anywhere else, and we have that fourth death, then we have four deaths in 80,000. If that record maintains there will be five deaths in 100,000. That compares to one or two deaths reported for every 100,000 suction abortions.

Now let's look at the psychological aspects of this. We know that a significant number of all women who have surgical abortions are extremely ambivalent about the abortion decision. They really don't want to do this. Something deep inside of them fights against it.

And yet, they feel they have no other option.

They feel they are boxed in and they go ahead to have the abortion. A psychological defense mechanism here is for her to close her eyes while she is on the operating table and say, "I don't want this, I don't want this. They are forcing it on me, they are doing it to me."

That won't work with the pill, for now she herself swallows the pills. She did it and there is no denying it. If she passes baby parts at home, she sees them and brings the pieces back in. We are of the opinion that there will be just as much post-abortion psychic trauma from taking the pill as we now see from surgical abortion.

Now let's look at the effect this pill has on the baby. There will be women who take the pill who do not abort, change their minds and go on to deliver. There can be many reasons for this. She herself was very ambivalent.

The pill didn't work. She takes it as a sign. It was not meant to be. She goes on to have her baby. Other women will talk with their husband, their boyfriend, their mother, their girlfriends, and they will be talked out of going for the surgical abortion. Another lady might not have understood the instructions, and didn't take all the pills, or maybe shared them with her sister. Another dropped one of the pills in the toilet and only took the other one. All of these did not abort. Some will change their mind and carry to term. What will be the result of having these babies.

She has taken a powerful, artificial, poisonous steroid drug. The purpose of this poison was to kill her developing baby. It didn't quite work. But it was poisonous, and it did injure the baby, and most importantly it was taken at the time of organogenesis. That is at the time when the legs and arms and fingers and heart are being built. It didn't quite kill this little child, but it can cause a malformation. From the malformations that we have seen in animals and in some babies to date, we are led to believe will be similar to those seen several decades ago from the drug, thalidomide. This was a drug sold over the counter in Germany for headaches. Pregnant women took it and they delivered babies with grotesque deformities of their arms and legs. It looks like this one may do the same.

Don't forget, there are two drugs here. The second is prostaglandin. Whether one or the other causes trouble will make little difference to the baby. We have one reported case from France of such a child who was born about 4-1/2 months, dead, with grotesque deformities of its lower extremities. We have reports from Brazil of women who were able to get the prostaglandin alone, took it in early pregnancy and delivered babies with deformities of their skulls and fingers.

Whether or not it will do this in many cases we don't know. It does do it consistently in rabbits. It does not do it in mice. We do have some human babies deformed. I believe that it is imperative for all nations to withhold the use of this drug until enough time has gone by to be sure that it is truly safe for babies.

Now let me turn to the alleged therapeutic uses of this drug. One of the possible uses that has received a lot of publicity is the treatment of a certain type of brain tumor known as meningioma. This is a slow growing tumor that can exist as long as ten years. It is characterized by stops and starts, that is it will grow for awhile and then stop for awhile. It does most of its damage by the pressure of the tumor expanding. So, it's a little hard to trace whether or not the medicine you are using is helping. This tumor has what we call progesterone receptors. Theoretically the use of this pill could lock up those receptors and this might retard the growth of the tumor.

Well, let's see what's reported. In The Journal of Neurosurgery 1991, we find the only major report to date. It is of 14 patients. In four of these the tumor continued to grow. In five the tumor was unchanged. Five saw a minor decrease in size but later regrowth. Now that's not even a very encouraging report. Certainly, it is not a dramatic one. Remember, these tumors come in both men and women. What were the side effects. In women, onset of menopause and hot flashes, baldness, fatigue. Men, all reported growth of their breasts. All in all, this is hardly a miracle drug.

Certain breast cancers also have progesterone receptors. What of treating these? To date there is one report in the literature. It was of 22 women, only four of whom had some benefit from the drug, but all four of those had recurrences and died. There are more studies of both of these tumors underway. A Canadian study has reported it is of no value.

Another suggested use for it is for an overproduction of adrenal hormone in a condition called "Cushings Syndrome." Here we see another function of this drug. It has anti-glucocorticoid activity. By virtue of this function, it should stop and reverse Cushings Syndrome. In fact, reports so far show that the woman's pituitary gland begins to secrete an antidote which blocks the action of this pill. That is the report in The American Journal of Endocrinology three years ago.

Now let me quote a few authorities who have reason to know a great deal about this pill. Several years ago it was taken off the market in France. The French Minister of Health personally put it back on the market and the French Government has been paying for its use ever since. Here is a quote from that Health Minister. "The doctor must have immediate access to an electrocardiogram as well as therapeutic equipment for cardiopulmonary resuscitation, a defibrillator, and intravenous injection drugs." The president of the Roussel Uclaf company, Dr. Sakiz, in an article on this concluded with this statement, "The woman must live with this for a full week, this is an appalling psychological ordeal." And here is the medical director of the Planned Parenthood Federation of America, Louise Tyrer, she says, "It is still an abortion and still requires close medical supervision."

I'd like to call your attention to a book that was published in 1991 out of the Massachusetts Institute of Technology. It has three authors, all three of these lady doctors can quite accurately be described as radical pro-abortion feminists. The title of their book is Ru-486, Misconceptions, Myths & Morals, (Raymond, Klein & Dumble, ISBN 0-9630083-0-7.)

To say that they denounce the pill is an understatement. An honest description of their book would be that they scathingly denounce the pill. Let me outline their interesting reasoning. Their book documents in minute detail the dangers of the pill. It also discusses in detail the fact that this pill has become, almost totally, a creature of politics in the United States. The pro-abortion movement sees as one of its political goals, having this pill legalized in the United States. They tell us that if the drug is licensed, many of the clinics that do surgical abortions will be closed. Then the pill will be used for awhile, but soon it will become evident that the pill is very dangerous to women, and will deform their babies. In due time the United States Food and Drug Administration will take the drug off the market and forbid its use. At such time they fear that the anti-abortion forces in the United States would be able to prevent the reopening of the surgical abortion clinics and there would be no way for many women in the United States to get abortions.

Consequently, they oppose the pill. I would suggest that any of you who really wants some ammunition against the pill, carefully read this book and quote freely from it.

In summary then, on the pill. Those who favor its use say that it is more private, but a surgical abortion takes one visit. This requires three or four. It is not more private. They say it is less expensive, but until you do the various blood tests, ultrasound, office visits and pay for both of these medications, this (at least in the United States and United Kingdom) will cost twice or three times as much as a surgical abortion.

Hoechst, Marion, Roussel does billions of dollars worth of business in the U.S. They own the Celanese Corp. They own agricultural chemicals, pesticides and drugs.

Who allowed the pill to come here?

Hoechst controls whether or not Roussel Uclaf can or will extend the license. If Hoechst, in Frankfurt, said "no go," the Parisian company could not have given the license. If there was no license then this drug could not have come to the U.S.

There was one exception to this. A decade ago an agreement was made with the World Health Organization that Third World countries could use the pill and if Hoechst and Roussel would not grant the rights, these countries had the right to make it anyway. China is one of those countries and is making and using it.

But, in the First World, and that is all of Europe, Canada, U.S., Japan, Australia, and New Zealand, they cannot bring it in unless the parent company in Frankfurt gives permission for it to come in.

Four years ago, pro-abortion delegations were going to Europe including Kate Michaelman and the National Organization of [some] Women. In response in Dec. 1990, I led a delegation to Berlin and visited Schering A.G. It makes a prostaglandin. We visited Frankfurt, the home office of Hoechst, and Roussel Uclaf in Paris. We also visited Rhone-Poulenc in Paris which makes another prostaglandin. I did not bring Right to Life people with me because the companies knew we were opposed to it. So, I reached out to para-pro-life groups and churches and the response was wonderful.

Those who came were the president or his or her representative. Dr. Richard Land for Southern Baptists, Knights of Columbus; Lutherans for Life; a very strong letter from Dr. Bob Dugan from the National Association of Evangelicals; Phyllis Schlafy, of Eagle Forum; a very strong letter from Cardinal O'Connor in New York; American Academy of Medical Ethics, Concerned Women; a very strong letter from Dr. T. James Kennedy who spoke for the broadcasting industry; Tom Minnery, vice-president of Focus on the Family; William Sherwin representing International Right to Life Federation and Drs. Glasow and Gerster from my office.

In talking to those folks we never used the word boycott, but it hung over our discussions like a cloud. Let me quote Dr. Land the first day we were there. He was so good I asked him to lead off at the next three meetings. He explained to them that Southern Baptists really weren't southern, and how often Southern Baptists go to church. This was to contrast with the typical western European practice of being baptized, married and buried in church whether you are Anglican, Catholic, Lutheran or Presbyterian. Three or four percent of the people in England go to church. Dr. Land said, "I can only speak for 15 million people, but if this drug comes to America it will ignite a fire storm." Dr. Jean Garton, represented Lutherans for Life. Jean is a sweet lady, the first woman to sit on the ruling Synod of the Lutheran church, Missouri Synod. Jean in her very charming way said that they had never really been too involved in issues like this, "but this pill has galvanized us."

And so, each of our people spoke in turn.

Each of our interviews was a full afternoon and done very professionally. We did let these companies know that they truly were sitting on a keg of dynamite if they brought that pill to America. Remembering that Kate Michaelman of National Abortion Action League had said that we were just an echo, I finished each meeting by explaining that we, around this table, spoke for a hundred million people.

There is another company involved. It is G.D. Searle, a drug company located just outside of Chicago. A few years back, I was the only formal testimony against it, when the FDA voted to license an oral form of prostaglandin called Cytotec. It is used with arthritis drugs like aspirin and ibuprofin to prevent your stomach from eroding and bleeding. That is on the market. Considering the liability involved, most doctors probably wouldn't use it for abortion unless the company went to the FDA and the FDA said yes you could use this for that purpose. The medical liabilities that hang over us are profound.

Searle has condemned the use of this pill for abortions in Brazil. At that hearing in 1988 when I testified against it, Searle said that they did not want it used for abortion. But David Kessler, reappointed by Bill Clinton to stay on as FDA head, invited the president of Roussel Uclaf to come to America. Dr. Sakiz met with Kessler. According to The New York Times and a couple of other reports and our own information, Kessler made a pitch to Sakiz to bring the pill over and assured him that he would see to it that Searle okayed the use of their prostaglandin, Cytotec. According to all of our information Searle is extremely reluctant to do this. Searle is owned by Monsanto which makes the sweetener, NutriSweet.1856, the anti-slavery movement had come a long way. Many thought it had peaked. This was four years before the Civil War. In 1856 there was a critical race for the presidency.

James Buchanan was a Democrat and supported slavery. John Fremont, whose party had just taken the name Republican, was charismatic.

Everyone thought he had it by a mile. He was against slavery. The race tightened in the stretch, a lot of mud was thrown. Buchanan won. They were faced with four more years of a pro-slavery administration. That was the fall of '56. In early 1857 the Supreme Court brought down the Dred Scott Decision. Dred Scott said, once and for all, that black people were not legal persons. This extended to all of the states. The Court said, don't bring us slavery anymore. It is over, we have settled it.

That sounds like the Casey Decision.

Later in 1857 there was a very important race in Illinois. An anti-slavery hero was running for the Senate against a pro-slavery candidate, but, Abe Lincoln lost. Talk about depression. But, three years later Lincoln was elected president and slavery was doomed.

Let me finish with a quote from Frances Schafer, a Presbyterian theologian. When he was barnstorming the country back in the late '70's, trying to rouse Christians to get into the marketplace, he said, "If we don't begin to use our freedom, to preserve our freedom, we will lose our freedom and our children and grandchildren will not call us blessed."

For whatever combination of reasons, the Hoechst Company in the spring of 1994 gave Roussel-Uclaf permission to give the patent rights to a United States company, The Population Council. Accordingly, a coalition of the pro-life, pro-family groups mentioned above and others have initiated what we hope will be a massive consumer boycott against all the products of the Hoechst Company, and subsequently against Hoechst, Marion, Roussel. To do anything less would have been to voice only an empty threat with no follow through. Accordingly, we are very serious about this boycott. There is no question but that there will be another effect of the boycott, as every other pharmaceutical company in the United States will be watching. We are quite aware of the fact that there are a number of chemically similar drugs in the pipeline being developed. The rights to these are owned by other drug companies. If Hoechst, Marion, Roussel is allowed to get away with this effort, unquestionably the other drug companies will be emboldened to market their versions of this drug. If Hoechst is severely stung by this, it should have a profoundly sobering effect upon the other drug companies.

In Hoechst's official statement regarding this boycott, they state, "The future of the drug in the United States is now in the hands of the Population Council and the Food and Drug Administration." That is true. It is also completely irrelevant. The reason is that Hoechst gave permission to give this patent to the Population Council.

Their statement says that the two European companies will now not benefit in any way from this drug. This is correct and also irrelevant.

The company states that the drug was given away because it did not "fit with the company's product line and scientific end product expertise." If true, the answer would have been to put this drug and its rights in a deep freeze and to not let it see the light of day.

The relevant fact is that Hoechst allowed Roussel Uclaf to give it to an avid pro-abortion organization for the specific purpose of marketing it in the United States.The bottom line then is, the Hoechst, Marion, Roussel Company is, and remains totally responsible, if the drug is ever licensed in the United States. Accordingly the boycott has been called.?

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