Abortion Groups Believe
FDA Rules on RU486 Made to be Broken

Indications are that RU486 is now available at many abortion clinics across the country. According to information found on the web site of the United States distributor - - Danco Laboratories LLC of New York - - shipments of the abortion pill were scheduled to have begun on November 20, 2000. A mass mailing by Danco, promoting the drug to other doctors and clinics, was supposed to have gone out about the same time, according to the Washington Post. Danco, the Post also reports, is working with Planned Parenthood (PPFA) and the National Abortion Federation (NAF) to "train more health workers and doctors in private practice to use RU486."

The impact of this potent chemical abortion technique is unknown, although proponents hope and opponents fear that its introduction will increase the number of abortions, which has been dropping for the past few years.

What can be said is that the Chinese company that will actually be producing the pills has compiled a record which casts serious doubt on the integrity of the company's production methods. In addition, there is the whole question of the thoroughness and objectivity of the inspections and evaluations made of the facility by the Food and Drug Administration (FDA). (For more, see stories on page 12.)

If that weren't bad enough, there are the huge concessions the FDA made to the abortion lobbies when the agency approved the RU486/misoprostol combination last September, which could significantly compromise women's safety. On top of that, as we shall see below, the ink had not even dried on the weakened initial guidelines for the use of RU486 before the abortion lobby began pressing for the use of RU486 two weeks later into pregnancy.

UNWISE CONCESSIONS

Although not well known, last summer the FDA floated some proposals that were geared to enhancing the safety of women using RU486. Most of the protective measures were thrown out when the FDA approved marketing last September.

For instance, instead of requiring that doctors be trained in the method, the FDA now expects only that prescribing physicians sign a paper saying that they had read and understood the physician information guides. Also under the September 28 FDA guidelines, doctors no longer would need to have the surgical training necessary to handle complications brought on by the potent pills. Instead, they need only attest that they had made arrangements with some other doctor or facility to handle such patients if they themselves couldn't.

Moreover, prescribing doctors no longer need practice within an hour of a hospital or emergency room equipped to handle such complications as long as they could certify that a woman had access to appropriate medical care.

Finally, the new guidelines do not require training in the use of ultrasound or the equipment itself, as long as a doctor professed an ability to date a pregnancy and diagnose an ectopic pregnancy.

Such concessions are highly questionable, in light of the significant risk of hemorrhage associated with these drugs.

(See the story by Joel Brind, Ph.D., that appears on page 15.) The real priority apparently is not the safety of women but the convenience of prescribing physicians. There is another area that raises red flags, which requires a quick summary of the "protocol" that will be used. As of now, the FDA still requires three visits.

On the first visit, a woman is examined. If she is pregnant, she is counseled and receives the RU486 pills. The action of this powerful artificial steroid is to cut off nutrition to the developing baby who, as a result, starves.

On the second visit two days later, the woman is offered a second drug--misoprostol (or Cytotec)--a prostaglandin which triggers contractions to expel the dead baby. About 12 days later, on her third visit, she returns to confirm whether or not the abortion is complete.

The FDA also authorized the same dosages used in the clinical trials and limited the use of the pills to the first 49 days of pregnancy. Tests had showed a sharp drop off in "effectiveness" after that point.

Now PPFA and NAF are boldly announcing that they find even these mild restrictions too confining.

According to the October 30 edition of the Wall Street Journal, both PPFA and NAF are distributing "standards" to their clinics suggesting that their members reduce the dose of RU486, increase the dose of misoprostol, and extend the time the combination will be offered an additional two weeks (up to 63 days into pregnancy).

Perhaps most significantly, PPFA and NAF are also reportedly telling participating physicians they can drop the requirement that the woman come back to the office for her second visit. Instead they would allow women to take the misoprostol at home, with all the attending physical and psychological risks according to October 30 Wall Street Journal.

It cannot be stressed enough that it is usually just following this second visit that a woman has her abortion. It is during this time that a woman begins her most severe cramping, her most serious bleeding, and runs her greatest medical risk.

If PPFA and NAF are allowed to brazenly make these alterations, it will be at this most vulnerable and dangerous period that a woman will be farthest away from the medical help she may desperately need.

According to the Journal, while the U.S. distributor for RU486 says it is still recommending the FDA protocol, it notes that the FDA-approved agreement doctors sign doesn't explicitly prohibit variations.

Not surprisingly, the proposed changes were not based on the results of the studies upon which the FDA gave its approval. Instead, "advocacy groups" produced their own research, thus shredding even the pretense of scientific objectivity.

The Journal reported,

In going beyond the FDA label for Mifeprex, the abortion-rights groups say they know they may invite more criticism from opponents of the drug. But, says [Planned Parenthood President Gloria] Feldt, "Doctors are always figuring out different and better ways to use drugs."

The abortion lobby compromised the FDA by getting it to consider this death drug in the first place. And now the FDA is finding out just how little respect the abortion lobby has for its weak- kneed authority and how little concern it has for women's health.