Birth control pills over-the-counter: debate evidence, not politics

I've waited to address this sensitive topic until after the midterm elections, when political slogans such as the phony "war on women" and trumped-up threats to religious liberty were discarded like so many campaign posters. It was curious to see the American College of Obstetricians & Gynecologists (ACOG) and Planned Parenthood attacking Republican Senate candidates for supporting over-the-counter birth control pills without a prescription - a position that, if the pills were free or the candidates were Democrats, they would probably have cheered. (When the American Academy of Family Physicians quietly supported oral contraceptives over the counter earlier this year, it was careful to specify that such purchases be covered by health insurance.)

As outlined in a 2012 ACOG opinion paper, the rationale for granting over-the-counter status to birth control pills goes something like this: unintended pregnancies are common; visiting a doctor for a prescription is inconvenient and unnecessary; oral contraceptives are safer than many medications already available without a prescription; women can screen themselves for contraindications; and women wouldn't stop seeing doctors for other preventive services. There are, however, very few studies that actually support these arguments; much of the literature simply surveys what other countries do regarding contraceptive access and assumes that outcomes are better (or at least not worse). And surprisingly, there's no research whatsoever that shows making oral contraceptives over-the-counter reduces unintended pregnancies.

This hypothesis would be relatively straightfoward to test in a randomized clinical trial. Enroll, say, five hundred non-pregnant, sexually active, pre-menopausal women without contraindications to oral contraceptives who don't want to become pregnant in the next 12 months. Randomly assign half of them to receive birth control pills without a prescription at a convenient pharmacy, and assign the other half to obtain contraceptives the usual way, by requesting a prescription from their family doctor or gynecologist. After a year, compare the numbers of unintended pregnancies and adverse events (deep venous thromboses, strokes, sexually transmitted infections) in each group. Other outcomes could include contraceptive adherence, appropriate use, and use of recommended preventive health care such as immunizations and screenings.

Why hasn't this study been performed already? Some physicians have told me that this question doesn't need to be studied because it's obvious that over-the-counter access to contraceptives would lead to fewer pregnancies. Others have insinuated that even asking the question is "anti-woman" and insensitive to the long history of gender bias in health and men using fertility to control and oppress women.

I say bull. This isn't only a political question, it's also a scientific one. Otherwise, why stop at putting oral contraceptives over the counter? Why not, for example, make it easier for millions of women and men with poorly controlled ("unintended") high blood pressure to treat themselves by making anti-hypertensive drugs over-the-counter? In fact, self-monitoring and self-titration of blood pressure medications is a strategy that is being seriously considered in high-risk populations. A recent randomized trial published in JAMA compared this strategy to usual care in five hundred primary care patients with hypertension and a history of stroke, coronary heart disease, diabetes, or chronic kidney disease. After 12 months, the mean blood systolic blood pressure of the intervention group was 9 points lower than that of the control group, with no difference in adverse events.

The outcome of the hypertension study wasn't obvious. It might easily have gone the other way. And for that reason, it was a question that deserved to be rigorously studied. Similarly, over-the-counter birth control need not be an evidence-free debate. Regardless of where you stand on this issue personally or politically, it's time to stop with the slogans and inform the discussion with science.