The Con: Life-Ending Drugs & Devices
Life-ending Drugs & Devices Explanation
HRSA’s mandated coverage for the “all FDA-approved contraceptives” inappropriately includes drugs and devices with known life-ending mechanisms of action, including the abortion-inducing drug ella.
The guidelines issued by the HRSA mandating coverage for contraceptives clarifies that its definition is broad: “All Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity.” Such a definition includes drugs and devices with known life-ending mechanisms of action, including the abortion-inducing drug ella.
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.
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]
Other FDA-labeled “contraceptives” also have known life-ending mechanisms of action. Plan B, commonly referred to as “the morning after pill,” can kill a human embryo by preventing implantation.[vi] Intrauterine Devices (IUDs) are also acknowledged to work not only by preventing conception, but by blocking implantation.[vii] Importantly, IUDs are being heavily pushed for use as “emergency contraceptives” and a recent study on so-called “emergency contraceptives” concludes that, “[i]ts very high effectiveness implies that emergency insertion of a copper IUD must be able to prevent pregnancy after fertilization.” [viii] (Emphasis added.) [ix]
Promoting the HRSA guidelines mandate, Kathleen Sebelius, the Secretary of the U.S. Department of Health and Human Services (HHS), has admitted that the FDA’s definition of “contraception” is not limited to a drug’s ability to prevent conception, but extends to blocking the implantation of an already developing human embryo. “The Food and Drug Administration has a category [of drugs] that prevent fertilization and implantation. That’s really the scientific definition.” [x] (emphasis added) Secretary Sebelius stated that under the new mandate, “These covered prescription drugs are specifically those that are designed to prevent implantation.” [xi]
Notably, 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[xii]; the FDA-approved “contraceptive” ella can work by ending an “established” pregnancy.
Though “indicated” for contraceptive use, mandated coverage for ella opens the door to off-label but intended-abortion usage of the drug being funded by all health insurance plans. This runs directly contrary to Senator Mikulski’s assurance that “abortion coverage [would not] be mandated in any way…”
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] Plan B Approved Labeling, available at http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021045s011_Plan_B_PRNTLBL.pdf (last visited Sept. 27, 2011). The FDA’s labeling acknowledges that Plan B can prevent implantation of a human embryo.
[vii] See http://www.womenshealth.gov/publications/our-publications/fact-sheet/birth-control-methods.pdf (last visited Sept. 27, 2011). The Department of Health and Human Services guide to “Birth Control Methods” describes among the mechanisms of action for copper IUDs, “If fertilization does occur, the IUD keeps the fertilized egg from implanting in the lining of the uterus.” For hormonal IUDs the guide states, “It also affects the ability of a fertilized egg to successfully implant in the uterus.”
[viii] J. Trussell et al., Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy, Office of Population Research at Princeton University (June 2010).
[ix] Other hormonal contraceptives are also argued to change the endometrial lining making a woman’s uterus “hostile” for the implantation of a human embryo. See e.g. Frye, An Overview of oral contraceptives: Mechanisms of action and clinical use, 66 Neurology S29 (2006). “[C]hanges in the endometrium may affect survival of a blastocyst within the uterus or prevent implantation.” See also Larimore& Sanford, Postfertilization Effects of Oral Contraceptives and Their Relationship to Informed Consent, 9 Arch Fam Med. 126 (2000) (citing the Food and Drug Administration “approved product information” for oral contraceptives in the Physician’s Desk Reference, “Although the primary mechanism of action is inhibition of ovulation, other alterations include changes in the cervical mucus, which increase the difficulty of sperm entry into the uterus, and changes in the endometrium, which reduce the likelihood of implantation.”)
[x] Kelly Wallace, Health and Human Services Secretary Kathleen Sebelius Tells iVillage “Historic”New Guidelines Cover Contraception, Not Abortion, iVillage, Aug. 2, 2011 available at http://www.ivillage.com/kathleen-sebelius-guidelines-cover-contraception-not-abortion/4-a-369771 (last visited June 12, 2012).
[xii] 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).