August 10, 2012

By Dr. Jozef Zalot PhD.

(Last of Two Parts)

[Part I]

Author’s note: In the first essay “How Did We Get Here?”, we explored the legal issues surrounding the HHS contraception coverage mandate. In this second essay we examine reasons why the mandate is problematic in terms of public policy.

The HHS Contraception Coverage Mandate:

Public Policy Challenges

 

By Dr. Josef Zalot PhD.

Last of Two Parts

Author’s note: In the first essay “How Did We Get Here?”, we explored the legal issues surrounding the HHS contraception coverage mandate. In this second essay we examine reasons why the mandate is problematic in terms of public policy.

Contraception and Abortion

The primary public policy difficulty with the 2011 HHS mandate is that it blurs the line between contraception and abortion. The mandate requires that any health plan that covers prescription drugs must include all FDA-approved methods of contraception. This includes, but is not limited to, prescription birth control pills, intrauterine devices (IUDs), the “emergency” contraceptive Plan B, and ELLA. The problem is that while these medications are marketed as contraceptives, their mechanism of action either is, or can be, abortifacient.

The claim that many FDA-approved contraceptives act as abortifacients surprises many, thus some background information is in order. The Catholic Church (among many other institutions) maintains that human life begins at conception, a teaching that, contrary to those who denigrate it, has a solid scientific and medical basis.[1] In light of this, the Church teaches that “every procedure whose sole immediate effect is the termination of pregnancy before viability is an abortion, which, in its moral context, includes the interval between conception and implantation of the embryo.”[2] This last phrase is crucial and, in fact, is widely misunderstood. In medical terms, pregnancy begins when the embryo implants in the uterine wall. Thus when physicians and pharmaceutical companies claim that contraceptives do not cause abortions–as they often do in advertisements and other public pronouncements–they are technically correct.[3] However, this medical understanding of pregnancy fails to take into consideration that for 3-5 days prior to implantation there is a unique, living biological entity, a human being in its nascent developmental stages, present inside the mother’s body. It is precisely because the embryo is alive prior to implantation that the Catholic Church maintains that one is never morally permitted to do anything that would directly impede its normal development process.

What does all this have to do with mandated contraception coverage? A lot. The latest FDA-approved emergency contraceptive is ELLA or ulipristal acetate. ELLA, which can be taken up to five days following unprotected sex, is intended to function pre-conception by postponing follicular rupture and thus delaying the onset of ovulation. However, it can also function post-conception by altering the endometrium (the inner lining of the uterus) rendering it “hostile” to implantation.[4] In other words, if fertilization occurs following intercourse, a secondary mechanism of ELLA is to prevent the newly formed embryo from implanting in the uterine wall, a clear violation of Church teaching.[5] However, preventing implantation is not the only possible post-fertilization mechanism. ELLA is a “selective progesterone receptor modulator” which means it blocks with the action of progesterone, a hormone necessary for the continued growth of the embryo. Thus ELLA can potentially terminate an “already established” pregnancy, a situation where the embryos has already implanted in the uterus. Evidence for this claim comes from the European Medicines Agency which has demonstrated through multiple animal studies that ELLA is “embryotoxic in low doses” and that it causes abortion, realities that have caused the FDA to maintain that ELLA is contraindicated after implantation.[6] Finally, it is important to note that ELLA shares a similar molecular structure to RU-486 or mifepristone, the post-implantation abortion-inducing drug that the FDA specifically states “is used to end an early pregnancy.”[7] The reality is that ELLA does not function solely as a contraceptive (“contra-conception”), its mechanism can also be abortifacient.[8]

It should be noted that there are valid concerns that pre-implantation mechanisms are at work with other FDA-approved “contraceptives” as well. For example, the FDA label for Plan B, a widely marketed emergency contraceptive, explicitly states that the medication “may inhibit implantation by altering the endometrium.”[9] Despite this warning (as well as its various possible side effects), Plan B (levonorgestrel) is available over-the-counter to women 17 years and older,[10] not to mention in vending machines on various college and university campuses. Similar concerns arise with intrauterine devices or IUDs. As just one example, a 2002 study on the mechanism of these devices concluded that postfertilization effects (including the prevention of implantation) make “substantial and essential contributions to the effectiveness of all types of IUDs.”[11] Again, these realities raise serious questions about whether Plan B and IUDs are contraceptives or abortifacients.

But what about prescription birth control pills, the primary focus of this paper? Do they act solely as a contraceptive or can they also act as an abortifacient? The answer is not 100% clear and is, in fact, the subject of significant debate. While it is generally agreed that the primary mechanism of oral contraceptives (OCs) is suppressing ovulation and thus preventing fertilization, many medical professionals recognize the possibility of secondary, post-fertilization mechanisms as well.[12] One mechanism is that the pills can work to prevent an embryo from migrating from the fallopian tube to the uterus, resulting in a possible ectopic pregnancy or in the death of the embryo before it can implant in the uterus. A second mechanism is that OCs can cause the endometrium (the inner lining of the uterus) to become thinner, less glandular, and less vascular – in other words “hostile” to implantation. If an embryo is not able to implant due to these physiological changes in the uterus, it dies.

So do OCs function through one (or both) of these mechanisms and thus act as an abortifacient? The American Association of Prolife Obstetricians and Gynecologists states that while OCs could affect tubal transport and implantation, the scientific methods presently available to evaluate these post-fertilization effects are not sophisticated enough to be definitive.[13] However, scientific research has demonstrated the effects that oral contraceptives can have on the uterus. Anderson (et.al.) reported that low-dose combination oral contraceptives given in the 21-day active/7-day placebo regimen have been shown to “suppress” the endometrium. The researchers further reported that when biopsies were done on study participants, the samples taken from woman who had completed the study (those who were no longer taking the oral contraceptive) “demonstrated a rapid return to endometrial cycling.” Conversely, biopsies taken from study participants who were still actively taking oral contraceptive “showed primarily inactive or atrophic endometrium.”[14] Bulten (et. al.) reported that “atrophic or inactive endometrium” was present in the majority of the biopsies performed on women after 1 and 2 years of using a vaginal ring, a finding “in line with the fact that low-dose combined oral contraceptives are known to inhibit the normal proliferative changes in the endometrium.”[15]

While these and other scientific findings are highly technical, altering the uterus to impede implantation is a common mechanism cited in much of the popular medical literature as well. The website WebMD explains that hormonal contraceptives including the pill, patch, and vaginal ring function, in part, “by making the lining of the womb inhospitable for implantation.”[16] The Physician’s Desk Reference, which contains FDA-approved product information, has stated that while the primary mechanism of OCs is inhibiting ovulation, “other alterations include … changes in the endometrium which reduce the likelihood of implantation.”[17] Evidence of a possible abortifacient mechanism extends to the oral contraceptives themselves. A cursory review of the labels for seven current FDA-approved OCs reveals that six of them list “changes in the endometrium [that can] reduce the likelihood of pregnancy” as a mechanism of action.[18]

It is important to note that these scientific findings raise a separate, although closely-related, challenge. Walter Larimore and Joseph Stanford argue that because there is evidence to suggest that OCs (particularly progestin-only formulations) can have post-fertilization effects that lead to the loss of the embryo, physicians have a moral duty to inform their patients of this reality:

[W]e believe that the lack of information regarding postfertilization effects in patient information materials about OCs represents a potential failure to provide complete informed consent. Furthermore, if this mechanism of an OC violates the moral requirements of a woman, then failure to disclose this information seriously jeopardizes her autonomy. If information about the mechanism of an OC is deliberately withheld or misstated, then an unethical deception occurs. Failure to disclose information that might lead a patient to choose a different method of treatment is generally considered to be unethical.[19]

The question of contraception vs. abortion is highly relevant for legal reasons as well. In federal law, the Church Amendment (1973) protects the right of hospitals and individual health care providers to refuse to provide or participate in abortion and sterilization on moral or religious grounds, and it safeguards conscientious objectors from discrimination. As the 2011 Interim Final Rules require the provision of contraceptives with known abortifacient mechanisms, as well as sterilization, the HHS mandate is in direct violation of this amendment. The Weldon Amendment, which has been included in every Department of Labor and HHS appropriations bill since 2004, extends conscience protection to any individual or institutional health care entity that refuses to pay for or provide abortion coverage. Particularly relevant for this discussion, the Amendment specifically defines a health insurance plan as a health care entity.[20] Thus, according to Weldon, no health insurance plan can be forced to provide coverage for abortion, but this is exactly what the HSS mandate now does.

Conscience protection is not the only area where the HHS mandate runs afoul of federal law. The General Counsel of the United States Conference of Catholic Bishops (USCCB) argues that the contraceptive mandate violates the abortion and non-preemptive provisions of the 2010 PPACA or health care reform act. Section 1303 (b)(1)(A) of the act states that “nothing in this title

shall be construed to require that a qualified health plan provide coverage of [abortion] services … as part of its essential health benefits for any plan year.” Yet, as has been demonstrated, numerous FDA-approved contraceptives blur the line between contraception and abortion, a reality that caused the General Counsel to point out that there is no indication in either the text or the legislative history of the health care reform act that Congress intended to bar mandatory coverage of surgical abortion, but permit the mandatory coverage of medical (or drug-induced) abortion. In addition, Section 1303 of the PPACA states that it is up to the discretion of the health plan issuer to determine what will and will not be included in a particular plan with regards to abortion services. The Interim Rules violate this provision because the HHS has taken it upon itself to require that all forms of “contraception” be included in all health care plans. Third, the HHS mandate violates President Obama’s Executive Order 13535 of March 24, 2010.[21] This executive order, a necessary provision in securing the bill’s passage in the US House of Representatives, was the Administration’s public assurance that no part of the health care reform act could be construed to require abortion coverage. Once again, the HHS mandate, issued with the Administration’s full backing, is a direct violation of the President’s promise to the American people.[22]

As a final note to this section, it is important to recall that during the public debate over the health care reform legislation, President Obama repeatedly assured the American people that if they liked their current health care plan, “nothing will change.” The fact of the matter is that health care plans are changing, and it is not the individual policy holders who are forcing the change. Due to the unilateral decisions of HHS and the Administration itself, individuals and institutions with health care policies that presently exclude contraceptive coverage are faced with two options. They can choose (a) to abide by the mandate and act in violation of their individual and/or institutional consciences, or (b) to refuse to abide by the mandate and be subject to hefty federal fines. Regardless of the Administration’s promise, change is occurring in many people’s health care plans.

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