December 23, 2022 marked a critical day for the emergency contraceptive levonorgestrel, more commonly known as Plan B. Since it was brought to the market, Plan B’s mechanism of action (MOA) has been the subject of much debate. The manufacturers of Plan B have long claimed that its primary MOA is delaying ovulation, thereby preventing pregnancy by ensuring that sperm and egg cannot come into contact. However, at the time of FDA approval in 1999, additional mechanisms for preventing pregnancy could not be ruled out – including those that would lead to an abortion. As a result, the possibility of an abortive mechanism has been indicated on Plan B’s drug label, making it a subject of controversy in the pro life community. However, after reviewing an application by Foundation Consumer Healthcare (the makers of Plan B), the FDA approved a change to the drug’s labeling material, removing abortion as a potential MOA for the first time since the drug’s initial approval.
Please read with discretion: This article contains discussion of sexual assault and abortion.
Could Changes to Plan B’s Drug Label Impact Catholic Healthcare for Victims of Sexual Assault?
According to the Decisional Memorandum, “Data are strong for a mechanism of action of delay or prevention of ovulation, and data are weak to speculative regarding any postovulatory mechanistic effects, such as on fertilization or implantation.” The Memorandum also contains a summary of the research submitted to the review team and of the team’s interpretation of that research. The FDA updated the Plan B information page on their website to state, in no uncertain terms, that in their professional opinion, Plan B is not an abortifacient.
For the majority of Catholics, the change in Plan B’s drug label does not have a particular impact. Because Plan B and generic forms of levonorgestrel are contraceptive, it is not permissible for Catholics to use within the context of consensual sexual encounters. As stated in the USCCB Ethical and Religious Directives for Catholic Health Care Services, “Just as the marriage act is joined naturally to procreation, so procreation is joined naturally to the marriage act.”
However, when it comes to contraception use there is one critical exception: instances of sexual assault.
Directive 36 of the same USCCB document states, “Compassionate and understanding care should be given to a person who is the victim of sexual assault. . . . A female who has been raped should be able to defend herself against a potential conception from the sexual assault.” Because sexual assault is not a consensual, unifying act, emergency contraception (EC) is permissible.
The USCCB document goes on to clarify that “if, after appropriate testing, there is no evidence that conception has occurred already, she may be treated with medications that would prevent ovulation, sperm capacitation, or fertilization. It is not permissible, however, to initiate or to recommend treatments that have as their purpose or direct effect the removal, destruction, or interference with the implantation of a fertilized ovum.” In other words, a method that prevents conception – but does not cause an abortion – may be used to treat a victim of assault.
Because the MOA of Plan B included the possibility of abortive action, its applicability for treating victims of assault according to the USCCB directive has, to date, been unclear. As a result, Catholic healthcare settings have differed in their policies regarding its use.
A 2005 nationwide survey of Catholic hospitals revealed that, of the 597 hospitals surveyed, 23% said that they would provide EC only to assault victims and 55% said that they would not provide EC under any circumstance. In order to mitigate the possibility of the drug having an abortive effect, other Catholic hospitals implement the “appropriate testing” prerogative in the USCCB directive by developing protocols to test for pregnancy or ovulation prior to dispensing Plan B. These protocols are not universally applied, however, as individual hospitals decide which protocols to use and how.
The FDA’s assessment of Plan B’s MOA has the potential to provide needed clarity in understanding the drug’s applicability to caring for victims of assault. If this new assessment is accepted by Catholic physicians, this would open the door to creating a standard of care for such cases within Catholic healthcare.
However, this outcome appears, at present, unlikely.
Many Catholic Physicians Remain Uncertain About the MOA of Plan B
As new studies exploring Plan B’s MOA have been published, the predominant interpretation among the authors has been that Plan B is not an abortifacient.
Studies of Plan B’s efficacy in preventing ovulation (its proposed primary mechanism), as well as studies of endometrial lining and hormonal changes following Plan B administration, led those scientists to the conclusion that Plan B acts by inhibiting or preventing ovulation, but would not affect a baby’s implantation in the uterus if conception did occur. In assessing the scientific literature, the FDA came to the same conclusion.
However, several Catholic physicians have voiced concerns over these studies, highlighting the studies’ limitations and offering alternative interpretations. One 2017 analysis of the scientific literature, published in the journal for the Catholic Medical Association (CMA), asserts that Plan B may not be as effective at preventing ovulation as it is marketed to be, and that it may indeed cause changes that would impact a pregnancy post-fertilization (i.e. that there is a possibility of having an abortive effect). A 2014 publication written by Dr. Kathleen Raviele, an OB/GYN and former president of CMA, emphasized that Plan B’s effectiveness at delaying ovulation is greatly diminished in the 1 to 2 days immediately prior to ovulation – calling to question whether the pregnancy prevention rate of 7 out of 8 women (as stated on the Plan B website) can be fully accounted for by ovulation delay.
Because of these lingering questions, the CMA issued a statement in 2015 that, as an association, it does not recommend Plan B for use as EC in cases of rape. The FDA’s decision to change Plan B’s drug label has not changed that opinion.
In an interview with Dr. Raviele, she explained that “[t]he FDA did not make that decision based on any new research” that fully addressed the CMA’s concerns. The National Catholic Bioethics Center (NCBC) released a statement in February of this year, echoing Dr. Raviele’s words. The NCBC said that “the FDA did not address all factors relevant to how LNG-EC can impact human life after fertilization” and that the organization would “maintain its longstanding position that Catholic health care institutions and professionals should ensure with moral certitude (that is, by excluding any reasonable doubts), at a minimum, that LNG-EC [Plan B] is not dispensed when it could not prevent ovulation but may well cause the death of an embryo.”
Notably, Catholic physicians may not be completely united in the CMA’s assessment of Plan B’s MOA.
Regarding the 2015 CMA statement, Dr. Raviele stated, “I can guarantee that many members may not agree with it . . . but the CMA has always been faithful to the Magisterium and this statement is in keeping with our mission.”
A 2022 publication in the CMA journal also argued that Catholic hospitals’ differing policies towards Plan B administration demonstrate that “reasonable disagreement exists among thoughtful Catholics on this issue.” In a follow up interview on this article, author Dr. Brummett elaborated on this thought, saying, “Whether there is ‘sufficient’ scientific evidence to ‘establish’ that [Plan B] has no abortive MOA depends upon what one believes to be at stake ethically speaking. For example, if you have heartburn, and I offer you a home remedy that I have seen work in a few friends, you might be open to trying it on the basis of that anecdotal evidence. However, if one believes that abortion is the murder of an innocent human life and therefore absolutely evil, then one's standard for ‘scientific proof’ might be very difficult, or even impossible, to meet. One might always demand another study, on another population, under another set of conditions in order to be satisfied.” Because further clinical studies would also be considered unethical to Catholics, differences in opinion in Catholic healthcare over Plan B’s MOA may never be fully settled.
While Plan B May Not be Universally Adopted in Catholic Healthcare, Other Avenues of Care are Available
While Plan B may not be able to be universally adopted in Catholic healthcare settings, it is still possible for Catholic physicians to provide compassionate care for victims of assault.
In the CMA 2022 article, Dr. Brummett and his colleagues argue that individual physicians should be allowed to follow their own conscience, calling for “Catholic leadership at hospitals that prohibit emergency contraception for rape victims to accommodate physicians who wish to provide levonorgestrel as a matter of conscience.” Permitting physicians within a Catholic hospital setting to draw their own conclusions from the scientific literature and to make care decisions accordingly has the potential to help resolve the conflict.
However, Dr. Raviele explained that one caveat to this approach is ensuring that physicians are able to balance their interpretation of scientific literature with ethical decision making. As she puts it, “The most important thing is that the physician’s conscience is well formed, and in many cases a physician’s conscience is not well formed.” As an alternative for physicians in Catholic hospitals that do not dispense Plan B, Dr. Raviele also suggested conducting a conscientious referral to a pharmacy, where Plan B is available over-the-counter.
Dr. Raviele’s 2014 article also highlighted another potential treatment option for victims of assault, which may have a higher certainty of preventing conception without causing abortion if taken before ovulation. Meloxicam, a non-steroidal anti-inflammatory drugs (NSAID), is a partially selective COX-2 inhibitor and an effective anovulant, preventing ovulation in 91% of women according to a 2010 study. A 2022 study also demonstrated no significant difference in endometrial line striping, indicating that implantation may not be significantly affected. Scientific exploration of meloxicam as an EC method remains preliminary. Nevertheless, it may be worth exploring as an alternative.
For Catholic Doctors, Providing Compassionate Care to Victims of Assault is a “Landmine of Conscience”
For Catholic doctors, providing compassionate, conscientious care to victims of sexual assault often calls for making difficult decisions between opposing goods. It involves looking carefully at the science of the treatments available, and balancing the interpretation of that data with moral imperatives.
It is, in Dr. Raviele’s words, a “landmine of conscience.” But, no matter the challenges, it is a landmine worth walking into.