October 5, 2010
This fall, Watson Pharmaceuticals will begin manufacturing a new drug called “ella.” Ella was approved by the Food and Drug Administration on August 13, and was categorized as an “emergency contraceptive.” That categorization is misleading: As the Family Research Council and several allied organizations have been explaining to pharmacists and the public at large, the drug has the potential to induce abortion.
Responding to this campaign, Watson Pharmaceuticals is claiming that ella is “not an abortifacient drug.” Yet the company did not address charges that the drug can abort an implanted baby. Nor did it dispute the FDA’s labeling information, which reads that “alterations to the endometrium [the inner membrane of the uterus] that may affect implantation may also contribute to the efficacy.”
Watson also failed to comment on the label statement that “pregnancy should be excluded before prescribing ella.” Why is ella “contraindicated” for pregnancy? Because, as the FDA notes, in studies of ella that were conducted on pregnant animals, all of the baby rats and half of the baby rabbits were aborted.
Watson made the obvious and uninformative statement that ella “is not RU-486,” yet did not address the key similarities between the two drugs. Ella and RU-486 have an almost identical chemical makeup and possess identical modes of action. (They are both selected progesterone receptor modulators.) By contrast, Plan B, currently the most widely used form of emergency contraception in the U.S., is a completely different class of drug and does not impact an already implanted pregnancy.
Ella and RU-486 both block the production of progesterone in a woman, which a fetus needs to develop and survive during its first ten weeks. In blocking progesterone, both RU-486 and ella can disrupt already-implanted embryos. In at least one study comparing the drugs at the same dose, ella was more potent in aborting animals than RU-486. Unfortunately, rather than address these scientific and ethical concerns, Watson simply labeled them “varying opinions.”
This dismissive response may mean that Watson does not fully understand the ramifications of marketing and disseminating ella. Until now, no major pharmaceutical company in the U.S. has ever willingly linked itself to abortion. When the Population Council assumed the U.S. rights to RU-486, Danco Labs was created (and chartered in the Cayman Islands) solely to sell the drug.