The Con: ella
Though “indicated” for contraceptive use, mandated coverage for ella opens the door to off-label intended-abortion usage of the drug being funded by all health insurance plans. This runs directly contrary to Senator Mikulski’s assurance that “nor would abortion coverage be mandated in any way…”
Like the abortion drug RU-486, Ulipristal Acetate (ella) is a selective progesterone receptor modulator (SPRM). Despite its “indication” for use as “emergency contraception,” ella – like RU-486 – can induce an abortion.[i] This is because an SPRM “works” by blocking progesterone, a hormone that is necessary for pregnancy.[ii] By blocking progesterone, ella can kill a human embryo even after implantation.
Put another way – ella can abort a pregnancy, no matter whose definition of “pregnancy” is used.
Studies confirm that ella is harmful to an embryo.[iii] The FDA’s own labeling notes that ella may “affect implantation,”[iv] and contraindicates (or advices against) use of ella in the case of known or suspected pregnancy. Notably, at the FDA advisory panel meeting for ella, Dr. Scott Emerson, a professor of Biostatistics at the University of Washington and a panelist, raised the point that the low pregnancy rate for women taking ella four or five days after intercourse suggests that the drug must have an “abortifacient” quality.[v]
ella’s deadliness goes beyond that of any other “contraceptive” approved at the time of the Affordable Care Act’s enactment. Without diminishing the legitimate and serious objections to the deceptive approval of other life-ending drugs and devices, it should be acknowledged that by approving ella as “contraception” the FDA has removed, not simply blurred, the line between “contraception” and “abortion” drugs. No longer is the FDA hiding behind a changed definition of pregnancy[vi]; the FDA-approved “contraceptive” ella can work by ending an “established” pregnancy.
Planned Parenthood, proud of the role it played in ella’s development,[vii] provides significant misinformation about the drug. Planned Parenthood’s background paper on ella cites a 1998 study for the proposition that “[e]mergency contraception prevents ovulation. It has no impact on pregnancies that are already underway.”[viii] However, to make this point, the study examined progestin-based drugs. In fact, the study also acknowledges that RU-486, and similar drugs, could be used as “emergency contraception.” There is no debate that RU-486 also causes abortions in “pregnancies that are already underway.”
Significantly, ella was approved by the FDA several months after the Affordable Care Act was enacted and, therefore, its inclusion in the preventive services mandate was not contemplated by Congress, even if other methods of “contraception” were. While forced coverage of contraceptives in private plans is an entirely new and unprecedented concept, in the case of ella, a new type of “contraceptive” drug, there is not precedent for its inclusion even in government healthcare programs. Only approved by the FDA in August 2010, there can be no reliance argument made on a history of taxpayer-funding for the abortion-inducing drug ella through government programs that cover other contraceptives.
[i] “The mechanism of action of ulipristal in human ovarian and endometrial tissue is identical to that of its parent compound mifepristone.” D. Harrison & J.Mitroka, Defining Reality: The Potential Role of Pharmacists in Assessing the Impact of Progesterone Receptor Modulators and Misoprostol in Reproductive Health, 45 Annals Pharmacotherapy 115 (Jan. 2011).
[ii] Planned Parenthood materials acknowledge that chemical abortions are accomplished by blocking progesterone. See e.g. Planned Parenthood of Arizona, Client Information for Informed Consent: using the abortion pill, available at http://www.plannedparenthood.org/ppaz/images/Arizona/web-AB_by_Pill_E(1).pdf (last visited Sept. 1, 2011). (“Abortion pill” is a popular name for a medicine called mifepristone….It ends the pregnancy. It does this by keeping your body from making a certain hormone called progesterone. The pregnancy cannot go on without progesterone.”)
[iii] See European Medicines Agency, Evaluation of Medicines for Human Use: CHMP Assessment Report for Ellaone 16 (2009), available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001027/WC500023673.pdf (last visited Sept. 27, 2011). See also ella Labeling Information (Aug. 13, 2010), available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf (last visited Sept. 27, 2011).
[iv] ella Labeling Information (Aug. 13, 2010), available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf (last visited Sept. 27, 2011).
[v]See Transcript, Food and Drug Administration Center for Drug Evaluation and Research (CDER), Advisory Committee for Reproductive Health Drugs, June 17, 2010, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM218560.pdf (last visited Sept. 26, 2011). “What’s very, very bothersome here, again, to me, is that we shouldn’t be seeing this much of an effect according to your presumed mechanisms of action; that if there is no abortifacient aspect of this treatment, no effect on implantation, I just can’t make these numbers jive, unless there is a substantial difference in the demographics according to the women who are presenting with this sort of data. …” “So this still comes back to this mechanism of action then. Why would we expect that if — and I’ll even concede that the primary mechanism of action might be delayed ovulation, but not in this group that’s five days out from unprotected intercourse.”
The response to Dr. Emerson’s questions given by Dr. Erin Gainer, representing HRA Pharma, ella’s sponsor, acknowledged that HRA Pharma lacked sufficient data to make an assurance that ella did not have an abortifacient aspect, “Again, given the variability that we know when ovulation actually occurs in a given cycle, it’s very hard to comment on how many of the women treated days 4 and 5 may have been post-ovulation. We don’t have biochemical data on the individual women included. So it is very hard to comment on where those women actually were.”
[vi] For an overview of the “changed” definition of pregnancy, see Christopher Gacek, Conceiving Pregnancy: U.S. Medical Dictionaries and Their Definitions of Conception and Pregnancy, FRC Insight Paper (April 2009), available at http://www.frc.org/life–bioethics (last visited Sept. 1, 2011).
[vii] See Planned Parenthood Fed’n of Am., Planned Parenthood Applauds Launch of a New Emergency Contraception in the U.S. (Dec. 1, 2010), available at http://www.plannedparenthood.org/about-us/newsroom/press-releases/planned-parenthood-applauds-launch-new-emergency-contraception-us-35386.htm (last visited Aug. 1, 2011).
[viii] Planned Parenthood Fed’n of Am., Inc., Background on Ulipristal Acetate (Ella) (2010). Planned Parenthood’s background paper on ella also cites a 1998 study for the proposition that “[e]mergency contraception prevents ovulation. It has no impact on pregnancies that are already underway.” Id. (citing Van Look & Stewart, Emergency Contraception, Contraceptive Technology 277 (17th ed. 1998)).