Drug maker faulted unfairly

By Laura Echevarria

(Editor's note: The following appeared in the January 10 edition of USA Today.)

G.D. Searle, manufacturer of misoprostol, an anti-ulcer drug that has been used "off label" in conjunction with the abortion drug RU486, is receiving a great deal of unwarranted criticism for its efforts to protect patients.

Searle's efforts to clarify the labeling of its drug, at the request of the Food and Drug Administration [FDA] - - by revising the labeling and by sending a letter to warn doctors that the drug should not be used by pregnant women - - have led proponents of the RU486 abortion method, including USA TODAY and the FDA, to criticize Searle.

But there's good reason for Searle to worry about misoprostol (brand name Cytotec) when used outside its original purpose as an anti-ulcer drug. According to this month's issue of Mother Jones magazine, the off-label use of misoprostol to induce labor in pregnant women has resulted in 30 reported cases of uterine rupture in the past three years alone and eight cases in which the babies died in utero.

When misoprostol was first approved as an anti-ulcer drug, Searle stated that it was contraindicated for pregnant women.

The science on which this conclusion was based has not changed, and the incidences of uterine rupture resulting from off-label use have served to underscore the correctness of Searle's position.
If misoprostol had not been approved by the FDA for use with the abortion drug RU486, then USA TODAY and other critics would more than likely be applauding Searle for its quick and responsible actions. It is only support for the RU486/misoprostol abortion method that has prompted such disparaging, politically driven comments regarding Searle and the "motivations" for its actions.

Instead of questioning the motives of Searle, people should be questioning the motives of pro-abortion groups and their sympathizers. Representatives of the American College of Obstetricians and Gynecologists admit that risks are associated with the use of misoprostol by pregnant women. Nonetheless, the organization criticized Searle because its actions "could limit the use of this new option for reproductive choice."

The FDA's campaign on behalf of RU486 strongly indicates that the agency's first priority is in preserving this chemical-abortion method. It is this, not women's safety, that is the controlling factor in the FDA's discussions with Searle over how misoprostol is labeled.

Will sound science and women's health once again fall victim to pro-abortion political pressure?
Laura Echevarria is director of media relations for the National Right to Life Committee.