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RU-486 Approval

ve8QAd   |   July 31, 1996

On July 19, 1996, an advisory committee to the U.S. Food & Drug Administration did exactly what it was appointed to do. It recommended the approval of marketing of the French abortion pill, RU 486, in the United States. It recommended that this pill be used with another pill, Cytotec, an oral prostaglandin, and that the two of them be approved as chemical abortifacients.

Sadly, this was an entirely predictable, political event and bore little relationship to the usual scientific evaluation that we expect from the Food & Drug Administration.

You may recall that right after President Clinton was inaugurated, he announced that one of his goals would be to have this pill approved for marketing – and quickly. His appointee as commissioner of the Food & Drug Administration was Dr. David Kessler. We use a term to describe him that I don’t recall that we’ve really used for anyone else…He is a political prostitute. He announced, contrary to everything that’s ever come out of the FDA, that, when the drug application was submitted, he would see that it would be approved within six months.

Understand, now, that the minimum time any life-saving drug has been approved in recent years was 19 months, and, typically, other drugs take three to five years. This is not a life-saving drug – it is a life-taking drug – but all rules are out the window when the pro-abortion Clinton administration wants something. And this drug-approval process has been politicized in an outrageous fashion.

The advisory committee was stacked with abortion-supporters. It seemed obvious that they never intended to really analyze the safety and efficacy of this abortion pill in any objective sense. Their votes approved it, and this was guaranteed from the beginning. They did hold a daylong event, but this was window dressing. It just gave to the pro-abortion media a platform that gave a veneer of scientific approval to this.

The panel reviewed data from two French clinical trials that reported on a total of 2,500 women. It also accepted preliminary results from more recent American trials involving 2,100 women. The American data were preliminary, have not been thoroughly reviewed nor verified. And one of the members of the panel, Dr. Mary Jo O’Sullivan, Professor and Director of Obstetrics at the University of Miami School of Medicine, publicly stated, “I don’t know why this meeting is being held at this time when the data are not finalized.” She pointed to the fact that this has never happened before – that the final data were not due for at least another six months, and that to accept preliminary data on such a controversial drug was unheard of. But hers was a lonely voice.

The final approval by the FDA does not have to follow the advisory panel’s recommendations. But in this case, take it as a given that it will follow it, for that is exactly why this stacked panel was appointed and this meeting set up.

A group of major pro-life organizations, reviewing the committee members, was appalled at the bias of those appointed. Reacting to this, on July 10 leaders from Life Issues Institute, Concerned Women for America, Focus on the Family, Christian Coalition, National Right to Life, and the Christian Life Commission of the South Baptist Convention officially wrote to Food & Drug Administration Commissioner David Kessler requesting that six of the people on the panel be removed. We gave in-depth documentation of their demonstrated active bias in favor of abortion.

In an unusually rapid reply one week later the FDA denied that there was any conflict of interest and stated that these peoples’ previous activities would have no bearing on their judgment. As it broke out, however, three of the six did not participate, and, I’m sure, because of our letter. The other three did, and they were all bad news. One was the committee chairman, Dr. Ezra Davidson. He had signed on to a full-page ad in the Washington Post, which defended unrestricted abortion and opposed any legislation that would restrict it. He was a member of the steering committee of Physicians for Choice of Planned Parenthood.

Dr. Diana Petitti, who also had a public pro-abortion track record, went ahead to join him in voting to approve this drug.

Perhaps the most upsetting one was Dr. Philip Corfman, executive secretary of the committee. He was responsible for overseeing the planning and conduct of the hearing. He has been an employee of Planned Parenthood and was a founding member of a leading pro-RU 486 lobbying organization, the Reproductive Health Technology Project. He was the guiding brains that put this committee together and saw to it that approval would be granted. He was not removed.

Of the eight members of the panel, the final vote was seven in favor, with one abstention. An earlier vote had been six to two to affirm that the French studies had established the efficacy of using RU 486, and to use this, then, was approved as a basis for approving the drug in the U.S. A third vote, six to two, stated that the benefits outweighed the risks.

During this discussion, Dr. O’Sullivan, the one member in opposition to these votes, when discussing the risk/benefit ratio here, pointedly asked, “Benefit to whom? If you’re talking about the woman, it may be beneficial to her, but it’s of no benefit to the baby whatsoever.” To our great surprise, the strongly pro-abortion Washington Post actually printed this comment of hers.

However, the final result was no surprise to anyone. The pro-abortion juggernaut moved smoothly ahead.

Newspaper columnist, Cal Thomas, said, “Those who want the FDA to approve the drug have so politicized the debate that sound medical treatment and moral reasoning have become casualties. FDA Commissioner David Kessler admonished the panel to consider `only science’ in making its decision. But,” Cal says, “it was only science that led to some of modern history’s most outrageous and immoral acts.” Clearly, he was referring to the Nazi experiments, which were only science and did not take into consideration any value judgments.

One of the things that speakers on both sides of this issue at the hearing agreed on was that marketing RU 486 would encourage more physicians to perform abortions. From the pro-abortion side, this would reverse the progressive decline in the number of physicians who now do abortions.

From the pro-life side, our speakers stressed again and again how the history of abortion in the U.S. shows that when the number of abortionists goes up, the number of abortions also goes up. We have over a million-and-a half abortions a year now — an appalling number — almost every third baby conceived in America. And this from the President who said that he wants to make abortion “safe, legal and rare”.

This only confirms what I’ve been saying – and that is that every action he has taken has been to make it not rare, but everywhere.

Another disturbing issue was – who should not take the pill. Basically, two sets of studies were given – finalized studies from France and preliminary results on studies from the U.S. In the French tests women who had the following health problems were excluded: those who smoked 10 or more cigarettes a day, had heart and circulation problems, asthma, glaucoma, diabetes, high blood pressure, kidney, liver or adrenal problems, anemia, and if they were over age 35. No recommendation was voted on by this panel as to whether women with such health problems would be excluded in the United States if this drug were licensed.

Another disturbing fact was that the U.S. tests did not examine women 18 and under. The recommended approval does not exclude its use for women 18 and under. And this is further evidence of the completely unscientific approach that is being taken in licensing this drug.

It seems rather evident that the concern here is not whether or not women with such health problems are adversely affected, or that the possibility exists that teenage women would have a different reaction than more mature women. One doesn’t know these things, you know, unless you test for them. All we have here is a headlong political rush to approve a “politically correct” drug and to do so within Mr. Clinton’s first term.

One of the few good things that came out of the hearing, if you can call it good, is that the pro-abortion people wanted approval for use up to nine weeks, or 63 days, after the first day of her last normal menstrual period. The committee, however, recommended that it only be used from 5 to 7 weeks. This means that if she comes in when she is one week overdue for her missed period, the pill can only be used in those next two weeks.

And who would use it? The panel merely stated that the abortionist who uses the RU 486/Cytotec combination must be able to diagnose and date pregnancy, identify a tubal pregnancy, have ultra-sound available and be able to do an emergency D&C to stop hemorrhage or to complete the abortion. Nothing was said about enforcing these, and, let me tell you, any doctor with a license to practice medicine could qualify under these recommendations.

Very disturbing was their recommendation that RU 486 must be administered “under the supervision of a physician”. It did not say “given by a physician”. This means that a nurse or physician assistant, rather than a doctor, may be the only person the aborted woman sees.

This will take three visits to the doctor. On the first visit, she is to take 600 mgs. of RU 486 by mouth. Two days later she is to return to the abortion facility. At that time only 3% of the women will have aborted. And so the remaining 97% will be given 400 mgs. of Cytotec, a prostaglandin drug. She then is to wait at the office for four hours. During the trials, about half of the women had aborted during those four hours. The remaining went home and awaited the abortion. Whatever passes from her she is to collect in a jar and bring back to the office. Needless to say, she’s going to get a look at some very tiny fingers and toes.

All of the women are supposed to return for a third visit to confirm that the abortion has been completed or that further attention is needed.

Now, in France, if that woman did not come back, they went out, got her and brought her back. But that kind of control simply doesn’t exist in the United States. We’ll have a lot of women who simply won’t return. Some of these women will have complications. A small percentage will not abort at all and they’ll carry their babies to term.

The most immediate risk from the pill is bleeding. The average woman in the test bled for nine days. The longest, 69 days. One who testified against licensing was a doctor who provided emergency room treatment to one of the women who participated in the Planned Parenthood trial in Iowa. His patient almost died from hemorrhage and was saved only with multiple transfusions.

And other problems? In the French trials, half of the women were nauseated; one-fourth of them vomited; four-fifths had painful contractions, with one-third reporting these contractions to be very severe; and many of them needed narcotics.

One of the members on the panel who voted to approve the drug stated that the term “safe” should not be misinterpreted “as free of adverse events and serious adverse events”.

In summary, in a complete disregard for the normal scientific processes that have always been a fact of life at the Food & Drug Administration, this drug’s approval has been totally politicized. Dr. David Kessler, head of the FDA, promised that he would have it approved within six months – a startling statement, since urgently needed, life-saving drugs have never gone through the approval process in less than 19 months, and a more typical approval process has been 3 to 5 years.

The panel appointed by Clinton was stacked with strongly biased, pro-abortion members. With one exception, they voted to approve this.

The hearings provided a platform for the pro-abortion press to frame the issue so that it looked as if this had been a scientific appraisal. Nothing could be further from the truth.

The American tests are finished, but we only have preliminary results – no final results until next year. No drug has ever been approved before the final results of the testing were in, but this one will be. And why? Because our pro-abortion President has exerted great pressure to have it approved.

No tests have been done on women 18 years and younger, and yet this panel approved its use for teenagers. In France it is not approved for use on women with at least 12 common medical problems. None of these restrictions were recommended by this panel.

In France this can only be used in clinics that have emergency medical facilities such as blood transfusion availability, defibrillators, electrocardiograms, and more. None of these requirements were recommended by this panel.

In short, this panel relied upon the experience of France, which has a far more rigid and controlled patient population than here. Our doctor-patient relationship is far looser, more voluntary and contains no requirements to have a woman return if she doesn’t want to. In France, if she doesn’t come back, they’ll go get her – they’ll bring her in, and she has little choice in the matter. In short, the testing that they relied on from France is not comparable to the medical practice in the U.S.

Further, what of the effect of this pill on future breast cancer? What impact will it have on future pregnancies? What of its effect on other organs? The panel did not ask these and other important questions.

Let me predict — women are going to again be guinea pigs. This could be another Thalidomide tragedy, another Dalcon shield tragedy. Some women will die. Some babies will be born deformed. But Mr. Clinton wants this. Dr. Kessler is doing what he has been asked to do. And the pro-abortion juggernaut rolls on.

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