Friday, December 5, 2014

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.


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