Agency drops important safety regulations on abortion pill
Clinton-Gore FDA Approves RU486

By Randall K. O'Bannon, Ph.D.
NRL-ETF Director of Education and Research

Corrupting government and medicine in one fell swoop, the Clinton-Gore Administration's Food and Drug Administration (FDA) approved RU486, the so-called "French abortion pill," for sale in the U.S. September 28. With that decision a United States government agency, charged with protecting the health and safety of its citizens, approved a drug for the purpose of taking a human life.
Vice President (and Democratic Party presidential nominee) Al Gore declared that he was pleased with his agency's decision, while Republican nominee Texas Governor George W. Bush called the FDA decision "wrong." Bush said he feared that instead of making abortion more rare, the abortion pill could make abortion "more and more common."
The Bush campaign also said that Mr. Bush would sign a bill banning RU486, if Congress passes it.
The drug, sold under the name "mifeprex" and marketed as "Early Option," is expected to be available to qualifying doctors at about the time of the November 7 elections.

The Chemical Abortion Experience
The way RU486 will be administered (the "protocol") in the U.S. will involve, at a minimum, two drugs and three office visits. In her first visit, after being screened for physical conditions that could make the drug more dangerous for her to take, a pregnant woman is counseled and signs an informed consent form listing some of the risks involved in the chemical abortion procedure.

She then will take three 200mg mifepristone (RU486) pills in the doctor's office. The effect of this powerful artificial steroid is to block the action of the hormone progesterone in a woman's reproductive system. The developing child is deprived of the nourishment he or she needs to live and thrive.

But used alone, RU486 is not "effective" enough. Thus, two days later, the woman returns to take misoprostol, a prostaglandin which initiates powerful uterine contractions to expel the dead or dying baby. About half of these women will abort in the next four hours, with half of the remainder aborting
within the next 20 hours.(However, some women will not expel their dead child for another week and a half. Not commonly known is that at least 8% will have incomplete abortions or not abort at all.)

A third visit two weeks later confirms whether or not the woman is still pregnant. If she is, she will be urged to have a surgical abortion to guard against the possibility that she will bear a child who has been damaged by the drugs.

There are any number of side effects. In U.S. trials, 2% of the women hemorrhaged and required surgical intervention to stop their bleeding. One out of a hundred women in the carefully controlled and monitored trial ended up in the hospital. We know that at least one Iowa woman nearly bled to death.

And as Newsweek mentioned almost as an afterthought, there are no studies of what the long-term effects may be.

Safety Measures Gutted
What ought to alarm everyone is that when the pill does go to market, it will be without many of the protections the FDA is reported to have considered proposing just four months ago. Such measures are absolutely essential in light of the potency of the drugs and the real potential for complications.

In June, the FDA was reportedly prepared to limit the prescription of RU486 to doctors who possessed the surgical experience necessary to handle the complications that can accompany RU486 and/or the prostaglandin used in tandem with it. Instead the agency knuckled under to the heavy political pressure from the abortion lobby. It dropped these patient protection provisions and several other safety measures in order to make things more convenient for the abortionists.

Also gone from the FDA's announcement was the requirement that doctors who prescribe the drug practice within an hour's drive of a hospital that has emergency services. Under the current guidelines, a doctor need only be able to refer his hemorrhaging patient to some doctor or facility capable of handling such complications.

U.S. trials followed the European protocol and required that a woman coming in for her second visit stay at the physician's office for four hours to wait for the second drug to take effect. (Between 50%-70% of women in the U.S. trials aborted during this four-hour window, with the remainder aborting later, or not at all.)

However, a requirement for that four-hour waiting period is not included in the current FDA guidelines. In an amazing turn of events, abortionists have been given free rein to send a woman home just before she enters the most dangerous and painful part of her abortion.

In its September 28 guidelines, the FDA does not even require that the abortionist undergo any sort of training in the use of the RU486/prostaglandin method. All that is currently required is that a physician sign a form indicating he or she has read the doctor's advisory that accompanies every package.

Ultrasounds and a requirement that prescribing doctors would be trained to interpret them, which were originally being considered by the FDA, are no longer directly mandatory - - not as long as a physician possesses the "Ability to assess the duration of the pregnancy accurately," and the "Ability to assess and diagnose ectopic pregnancies."

Though the distinctions may appear minor, the result is a great widening of the pool of potential abortionists to include family practitioners, pediatricians, and other doctors, whether they have surgical or obstetrical training or not. Those doctors no longer have to buy special ultrasonic equipment or set aside special waiting rooms or bathrooms for ashen-faced, nauseated, cramping women to abort.

And if she does begin to hemorrhage in the middle of the night, or fails to abort with the medications, it's not the prescribing doctor's problem, but the stranger whose number the woman has on a crumpled up piece of paper in her purse.

Dissembling and Distortion
Both the White House and the FDA cast the decision as one of " medical science" rather than politics. But neither ever explained precisely what it was about "science" that mandated the development of new ways to kill human beings.

Declarations of the pill's safety are somewhat disingenuous as well. Promoters of the pill like to say that RU486 has been used safely by over 620,000 women in Europe. What they don't mention is that there are stringent safeguards in place in Europe limiting dispensation to specially authorized facilities, requiring emergency resuscitative equipment, numbered pills, additional visits, etc.

Also ignored are the dramatic differences between European health systems, where socialized medicine is in place and people are used to having their medical encounters supervised by the government, and the system in United States, where the population is much more scattered, diverse, and used to making its own health care decisions.

Not surprisingly, "success" rates have been higher in France than the United States and compliance issues - - the percentage of women failing to return for their critical follow-up visits - - are a real concern. Five percent of the women in the U.S. trials never returned for their final doctor's visit to confirm their abortions.

Chemical abortion methods such as the RU486/prostaglandin method expose a woman to a whole new series of risks. While a woman facing a surgical abortion runs the risk of uterine perforation, cervical laceration, scarring, and infertility, a woman undergoing a chemical abortion may face the possibility of a ruptured uterus, hemorrhage, or heart failure.

Instead of admitting that it has approved an abortion pill which takes the life of a child with a beating heart, the FDA perpetuates public ignorance by euphemistically describing the action of the drugs as "ending your pregnancy." The word "abortion" rarely, if ever, appears in the patient literature.

This evasion is astonishing in light of one of the chief concerns expressed by those doctors who offered the method during clinical trials: the frequent failure of women to come to grips with the fact that a chemical method was still an abortion.1

The Impact of Approval
Supporters of RU486 have promoted the abortion pill as one way to increase "access" to abortion. Two statistics are advanced repeatedly. The first is that over 80% of American counties lack an identified abortion "provider." The second is surveys that suggest that sizeable proportions of doctors who are not now performing abortions would consider it if RU486 were approved.

This is obviously grounds for concern. If the number of doctors offering abortions increases considerably, and the number of women considering abortion rises, the number of abortions could be expected to increase as well.

Demand will be higher as long as the false image of RU486 abortions as easy, safe, and simple holds sway. Women who might be afraid of surgical abortion and its risks may consider a chemical abortion that seems like an easy way out of a crisis pregnancy. Boyfriends reluctant to push their girlfriends into surgery may have fewer qualms about pressuring them into abortions that they believe only require the swallowing of a few pills.

Doctors who believe the hype may see the opportunity for easy, anonymous profits, where all one need do is sign a prescription pad. And, given the minimal restrictions the FDA has placed on those who might offer the pill, a great many might be tempted to look into the possibility.

All these things could increase the number of abortions.

Other factors could limit RU486's impact. Once doctors begin to find out what a complex procedure the RU486/prostaglandin abortion really is, they may change their minds about bringing the hassle and worry into their offices. Once the stories begin to get around about women being rushed to emergency rooms, about failed abortions and chemically damaged babies, interest in the drug could well wane.

Liability suits from injured women and grieving families could frighten off patients and physicians alike and the realization that the abortion industry and lobby has once again put politics and profits ahead of people's lives may finally prompt a much needed re-evaluation of their RU486 message.

It is abortion's increasingly negative image and declining public support that has prompted the abortion industry's interest in new, more sellable, methods of abortion in the first place. The number of abortions performed in the U.S. has dropped considerably in the last 10 years, with decreased demand for abortion being one of the chief factors in the decline.

Public support for abortion has waned since the campaign to ban partial-birth abortion began exposing the lies of the abortion industry and showing abortion for what it was.

Where Do We Go From Here?
To combat the abortion industry's latest image makeover, it will be important for the pro-life movement to do what it has always done: tell the truth about abortion. Let people know that every abortion, chemical or surgical, ends the life of a unique and special individual, no matter his or her age, no matter his or her stage of development. Make it clear that all of us are simply older embryos, and that the loss of a single life diminishes basic respect for us all.

We must also bring to public attention that the life of every mother is put at risk with this chemical cocktail. It will not be easy. If history is any guide, the abortion industry will try to cover up any deaths or injuries suffered by these women and explain them away as "attributable to other causes."

Congress can seek to make sure that the FDA demands and receives a full reporting of every complication in the post-marketing phase of the trial that follows release of the drug. If that evidence is forthcoming, it could provide the next administration's FDA with the data needed to overturn this cynical political decision of this administration's health and safety agency.

If the truth gets out about RU486, and honest men and women return to government, this latest chapter could be a sad but short one. Let your voice be heard so that those who have no voice will not be forgotten.

NOTE:

1. Carole Joffe, "Reactions to Medical Abortion Among Providers of Surgical Abortions," Family Planing Perspectives, January- February, 1999, pp. 35-38.