In Our Control (33 page)

In all of the ideological scrambling over emergency contraception, one of the FDA’s most basic criteria—how well emergency contraception works—has been pushed to the corners of the conversation. Indeed, while EC boasts hearty safety statistics, serious questions remain about how well it actually prevents pregnancy. For activists who support greater access and education around Plan B and other EC methods, the hope surrounding the drug is multifaceted. First and foremost, they hope that it will help reduce teen pregnancy rates and unwanted and unplanned pregnancies in the larger female population. In the United States it is estimated that 3.5 million unplanned pregnancies occur each year,
⁵⁷
30 percent of them in teenagers.
⁵⁸
Before the battle over OTC status, some scientists and population experts estimated that that this number could be reduced by half if emergency contraception was broadly used.
⁵⁹
With several years of use, studies were unable to demonstrate a significant reduction in unwanted pregnancies between women with increased access to the drug and those who needed to go through doctors. The question remains: do unwanted pregnancies remain high because EC doesn’t work as well as medical experts believe, or is it because even patients who can procure the drug don’t use it?

While certainly some women remain unaware that a postcoital option exists, they are increasingly the minority. One trial found that “some 64 percent of reproductive-age women surveyed in 2004 said that there was something women could do to prevent pregnancy following sex, and 75 percent of those women mentioned emergency contraception.”
⁶⁰
Studies show that awareness of the drug has exploded, due in part to heavy media coverage of controversies surrounding its status. So why are so few young women taking advantage of backup contraception?

When I talked to a group of college women at a small school in the Northeast, they were informed about the availability of Plan B as an option and very clear about the willingness of their school health services to provide it. One girl explained to me that she has taken Plan B a couple times despite using both condoms and the pill: “I take Microgestin and my boyfriend uses condoms every time. But once or twice the condoms have broken, or I’ve forgotten to take my pills. So, yeah, then we’ve used the morning-after pill.” Perhaps low use is simply a process of education, and with a few more years of increased availability, more women will opt to turn to EC in unanticipated situations.

Much seems to hang on how patients interpret the word “emergency.”
⁶¹
While there isn’t currently a limit on how often the drug is used, EC is intended to be employed only when other strategies have failed. A frequent argument against the easy availability of emergency contraception—one of the few to be voiced by those on both sides of the political spectrum—is that it might encourage people to rely on less effective methods of birth control or even engage in high-risk behaviors like unprotected sex with the belief that the potential consequences of these lapses can be accounted for after the fact. A deep concern on the part of conservative opponents seems to be that knowledge of Plan B will lead men to pressure female partners into condomless sex. Some cite studies that show a return to unsafe sex practices following the development of powerful drugs to treat AIDS in the 1990s.
⁶²
Most studies suggest that these fears are unfounded, and that the availability of these drugs doesn’t lead to riskier behavior.
⁶³
However, at least one study has indeed found that EC knowledge can lead some to take more chances. In my conversations, a theme that emerged again and again was that the women who were informed about EC were more likely to be using other contraceptive methods and were among the most educated and motivated when it came to protecting their health.
⁶⁴
Far from taking a devil-may-care approach to contraception, these women were doing everything they could think of to prevent pregnancy
and
sexually transmitted diseases.

Efficacy still dogs the drug, and even large meta-analyses fail to find a reduction in pregnancy even when EC is readily available.
⁶⁵
One source of concern is that access studies, which fail to demonstrate a reduction in unplanned pregnancies, do show that women with greater access to EC
are more likely to take it.
⁶⁶
So if more women are using the drug, why aren’t pregnancy numbers down? Two different but deeply related efficacy issues are up for discussion here: the first is the ability of the pill to prevent pregnancy in an individual woman, and the second, its ability to reduce pregnancy on a population level.

Official efficacy rates suggest that EC reduces the risk of pregnancy substantially. One estimate figures that if one hundred women engage in sex without protection in the second or third week of their cycle, eight will become pregnant. Another study finds that with combined Emergency Contraception Pills (ECPs: pills that have both estrogen and progestin), only two will become pregnant (a 75 percent reduction) and with progestin-only pills, only one woman will conceive (an 89 percent reduction).
⁶⁷
Other figures are not so optimistic, figuring efficacy as low as 49 percent.
⁶⁸
Writing in the journal
Contraception
, Elizabeth G. Raymond, Jennifer Liku, and Eleanor Bilma Schwarz note that estimates placing efficacy in the 80 and 90 percent range are “probably false,”
⁶⁹
and figure the real reduction is closer to 50 percent, noting that “a robust estimate of the efficacy of emergency contraception is not currently available.”

Why is it so hard to tell how well EC works? These authors note the difficulty of mounting a trial to assess this, citing, among other problems, ethical concerns with creating controls. In other words, scientists can’t ask a group of women who have engaged in unprotected sex not to take the drug or give them a placebo, so getting good comparative data is tricky.

What seems undisputed is that for individual women, taking emergency contraception provides some real, if variable, protection against pregnancy. Though use is still relatively low—one British report estimates that only one in ten women wishing to avoid pregnancy turn to emergency contraception when they are at risk
⁷⁰
—it is safe to say that EC is a valuable resource that women should be able to access at will.

From Emergency to Everyday Use: Should the Pill Go Over the Counter?

The fortunate lack of a safety disaster in the Plan B experience has renewed old controversies about whether traditional birth control pills
should follow emergency contraception over the counter. Some countries, including Spain and Russia, already offer the Pill without prescription.
⁷¹
Other nations, including the United Kingdom, have been cautiously piloting programs to test the safety and feasibility of such a move.
⁷²
By late 2008, two London districts had received permission to offer OTC birth control pills.
⁷³
The program will work through something called patient direction, in which a doctor can authorize a pharmacy to provide pills without prescriptions to a certain group of patients. Women will still need to have their blood pressure checked and their medical information reviewed to ensure that they don’t have compelling contraindications.

Momentum for making the change away from prescriptions built in 2008 when the prestigious medical journal the
Lancet
recommended that offering the Pill directly to consumers would cut ovarian cancer risks. In the dramatic article scientists estimated that in the fifty years the Pill had been available it may have prevented as many as one hundred thousand deaths.
⁷⁴
The authors concluded, “This latest study raises the question again of whether oral contraceptives should be made more widely available to women to protect them from ovarian cancer. We believe that the case is now convincing. Women deserve the choice to obtain oral contraceptives over-the-counter.”
⁷⁵
Learning a lesson from the history of emergency contraception, advocates of nonprescription pills realized they needed a health imperative to spark acceptance of this controversial, if not new, idea. Much like the relegalization of contraception in the United States from the 1920s to the 1960s, as well as the initial legalization of the Pill, the case for access has been couched in terms of disease prevention rather than female sexual empowerment.

Other experts are quick to point out that neither the evidence nor the issues are so clear cut. Rosanna Capolingua, the president of the Australian Medical Association, says efforts to remove prescription requirements from the Pill will not advance women’s health: “We’ve known about the link between ovarian cancer and the Pill for some time, but it [the Pill] inherently has other risks and so that’s why it’s important that it’s prescribed by a doctor who can assess a woman’s particular circumstances.”
⁷⁶

In other words, prolonged hormonal contraception is more complicated than EC. It requires more understanding and knowledge of an individual’s health issues and can have more serious outcomes if used
incorrectly. More conditions make the Pill a bad idea, and there are a greater number of problems that need to be constantly monitored by a doctor.

And so the role of doctors as administrators of women’s health again comes to the fore. Access to hormonal contraception has long been a powerful incentive for women to maintain regular relationships with health care practitioners. Many public health care experts fear that removing the requirement that the Pill be prescribed would eliminate many women’s most powerful motivation for having yearly Pap smears, HPV tests, and other evaluations that can be powerful indicators of wellness or infection. Indeed, whatever ovarian cancer prevention might be achieved through increasing access could easily be eliminated by increased cervical cancer if women fail to have their yearly exams.

When I spoke to Amy Allina of the National Women’s Health Network, a grassroots women’s health group in Washington, DC, that takes no money from drug companies or device makers (and that therefore tends to be able to criticize potentially dangerous drugs more frankly), she told me that while the network’s position on over-the-counter OCs “has evolved slightly” over the years, what hasn’t changed is the feeling that the benefits of increased access to the Pill should outweigh the risks of women taking the drug without expert medical advice, if such a change is to happen.
⁷⁷
It is likely that when women take the Pill without consulting with a doctor or nurse, women who shouldn’t consider hormonal options—particularly those with increased cardiovascular risks or undiagnosed diabetes—will take the drug.

The problem, Allina explains, is that it turns out that doctors don’t have a great track record with filtering out women who shouldn’t be on the Pill. So even if they
do
consult with a doctor, women who should not be prescribed the Pill often are. In fact, studies suggest that when women are handed a list of health considerations and given the opportunity to self-educate, they do a better job than doctors at spotting potential health red lights (the only place where this doesn’t seem to be true is with undiagnosed hypertension). Unfortunately, the ability of women to self-educate and administer medicines is largely left out of the conversation.

So is the problem that women who want hormonal contraceptives can’t get them? Dr. Sarah Jarvis of the Royal College of General Practitioners in
the United Kingdom argues that the problem for most women is not access to pills, but rather adherence to daily regimens: “Compliance is low with oral contraceptives. In one study of women using oral contraception, 47 percent missed one or more pills per cycle, and 22 percent missed two or more.”
⁷⁸
In other words, the problem isn’t that women can’t get pills—it’s that they can’t seem to take them correctly. But a survey in the United States suggested a contrary position: 41 percent of those surveyed who were not currently using oral contraceptives said they would start if they were able to get the drug without going through a doctor.
⁷⁹

While many women may like the idea of bypassing medical professionals on their path to reproductive independence, economic issues may preclude this reality for a large number of people. Granting oral contraceptives OTC status would mean that they would no longer be covered by insurance. This would pose a serious problem for low-income women and at least an inconvenience for others. And it would be difficult to send one pill over the counter without allowing others to follow. The reason for this is that so many oral contraceptives are “me too” drugs—pills that are similar enough to existing drugs that they have used existing safety data to gain FDA approval. If one company received permission to market their pill over the counter, any other pill that used the same safety data for green-lighting would have to go over the counter as well.

Because of this, those wrestling with the OTC issue suggest that perhaps progestin-only pills (POPs) should go over the counter and combined pills (those with estrogen and progestin) remain with prescription status. This way, those who rely on insurance to pay for pills could get them, and those who wanted to buy them in a drugstore without a prescription could also be accommodated. This isn’t a perfect plan. Because POPs are newer, we have a lot less information about their efficacy and their unique concerns. Sending POPs over the counter creates a risk of “classing” the pill and creating a situation where women who would need to rely on POPs would be stuck with a product about which we have less knowledge.