[NOTE: On November 24, 2004, The American College of Obstetricians and Gynecologists sent the following letter to the editor of the New York Times, challenging an op-ed piece that questioned the safety of RU-486 for early medical abortion.]

To the Editor:

The assertion by anti-abortion activists that RU-486 (Mifeprex) is "Dangerous Medicine" (op-ed, Donna J. Harrison, November 19) is simply not supported by medical facts or history.

Take, for example, the claim that the use of RU-486 for early abortion was rushed through the Food and Drug Administration approval process in 2000 without sufficient safety review. Just the opposite is true.

The US took an exceedingly long time approving RU-486, in part due to political pressures. At the time of its FDA approval, RU-486 had already been used by more than half a million women in Europe and by even more women in Asia for over a decade. Regulatory agencies of eighteen nations had already approved it. Clinical trials of hundreds of thousands of women abroad, and 2,000 US women (with peer-reviewed studies in journals such as the New England Journal of Medicine), had long-since found the medication to be a safe alternative to surgery for early abortion.

Not only did the FDA take a long time approving RU-486, it did so only after imposing strict limitations on its use by physicians. Some of these restrictions were opposed as excessively cautious by organizations such as ours. (The FDA also considered -- and rejected as unnecessary -- the even more severe restrictions that Dr. Harrison's group keeps demanding.)

Far from being inherently dangerous, RU-486 has an impressive safety record in the US -- just as it does across the globe. An estimated 360,000 US women have used RU-486. Three women who received it have died (although a causal link to RU-486 is not yet clear in all three cases). Nevertheless, the fatality rate for RU-486 -- less than 1 death (0.8) per 100,000 procedures -- is still extremely low. For perspective: it's less than the fatality rate from a shot of penicillin (2 deaths per 100,000 cases) and nearly identical to women's low death rate from common miscarriage. It's far less than the fatality rate for childbirth (about 12 maternal deaths per 100,000 births), and its risks are lower than those for dental procedures and hernia operations.

Do these facts diminish the tragedy of even one death from an FDA-approved drug? No. Vigorous, reasonable efforts to make RU-486 even safer for US women are welcome. The FDA's new labeling information is an important supplement to the product's already-comprehensive precautions and patient counseling requirements.

But to say that the safety record of RU-486 merits its withdrawal as a choice for US women is absolutely unwarranted. Imposing politics into the fact-finding process of the FDA is the real "dangerous medicine."

Sincerely,
Vivian M. Dickerson, MD
President
The American College of Obstetricians and Gynecologists

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