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Congress Can Stop the Harm to Women

 

by Susan E. Wills

February 10, 2006

Here's a riddle for readers: Name the terrible affliction that since 2000 has hurt over 800 women, but is completely preventable by legislation.

Need some clues? Here are some symptoms documented in reports to the Food and Drug Administration (FDA) on "Adverse Events":

Infection and Septic Shock: five deaths in North America alone; 66 additional infections, 46 of them life-threatening or serious.

Hemorrhaging: one teenager outside the U.S. died from bleeding; 42 women suffered life-threatening bleeding. Of the 237 women reported as hemorrhaging, about 70 required emergency blood transfusions; some lost over half their blood volume.

Ectopic pregnancies: The mystery affliction can mask the presence of an ectopic pregnancy, which then might not be detected until it ruptures. Without surgery, women rapidly bleed to death. One died and eleven others suffered ruptures out of 17 such events.

Documents record 235 emergency surgeries due to this affliction. Women have had heart attacks, and others needed stitches to close head wounds sustained when they lost consciousness.

Give up? This "affliction" is RU-486, a little white pill that was supposed to make abortion safe, effective and available in doctors' offices all over the country – but it has failed, spectacularly, on all counts.

Dr. Michael Greene, while he defends RU-486 in a recent medical journal, also notes that it causes ten times more deaths, from infection alone, than occur in early surgical abortions. He doesn't include deaths from ruptured ectopic pregnancy, hemorrhaging and heart attack. The risk may be far worse. His calculation is based on reported deaths from infection divided by total RU-486 abortions. But no one's sure of either number. The FDA estimates it is notified of only 1-10% of adverse events, so there may be unreported deaths and thousands more women injured. We don't even know how many RU-486 abortions have occurred; the distributor cites a figure that is three times the number of packets , regardless of whether they've been used.

How could the FDA approve such a dangerous drug? Wasn't it properly tested? In a word, no.

The FDA abandoned its "gold standard" for drug approval – two randomized, blind, controlled clinical trials. Instead, it settled for one uncontrolled trial in America, and one French trial rife with errors and falsifications (according to the FDA's own statistical review).

The agency also erred in approving RU-486 under its "fast track" regulatory authority ("Subpart H"). This authority applies only to drugs needed to treat "serious or life-threatening illnesses" (e.g., AIDS, leprosy, sepsis, cancer), where the new drug provides a "meaningful therapeutic benefit to patients over existing treatments."

Note to FDA: Pregnancy is not a disease, and RU-486 has no therapeutic benefit.

Congressman Roscoe Bartlett and 79 co-sponsors are seeking action on H.R. 1079 ("Holly's Law"), which would temporarily suspend RU-486 approval pending review of the FDA's conduct in approving the drug. Please ask your representatives to support this life-saving measure.

Susan Wills is associate director for education, U.S. Conference of Catholic Bishops' Secretariat for Pro-Life Activities. 



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