Inconvenient Contraception

Last week, birth control for college students got cheaper. An "affordable birth control" provision in the 2009 appropriations bill, which President Barack Obama signed last Wednesday, restored an incentive for drug makers to offer college health clinics discounts on the pill (the longstanding incentive had been inadvertently eliminated in a 2005 deficit-reduction bill). Still, even when it's cheaper, birth control will continue to be two things: inconvenient and thoroughly tied up with the medical system.

A trip to the doctor. Time off from work. A waiting room. A pap smear. A co-pay (assuming you're insured, of course). A trip to the pharmacy. Another co-pay. Then, finally, your birth control: 28 little pills, packaged in foil and plastic, standing between you and a pregnancy you don't want.

If you are one of the 11.6 million women in this country who relies on the pill to prevent pregnancy, this scenario, or some variation on it, has played out in your life again and again. It may not have to be this way.

"A pap smear is important. The pill is important. There's not really a connection between the two," says San Francisco gynecologist Dan Grossman. "It's a very paternalistic attitude to say, as a physician, we have to hold women's pills hostage -- you can't get your contraception until you get your pap smear."

England's National Health Service recently announced that later this year it will launch a pilot program to allow young women in two London neighborhoods to buy birth control over the counter after a brief consultation with a pharmacist. The London program is modeled after a pilot program that was conducted in Washington state between 2003 and 2005, in which 26 pharmacists throughout Seattle safely provided hormonal contraception -- the pill, patch, or ring -- to almost 200 women without a prescription. A similar study is being planned for California.

Now, a group of doctors, pharmacists, researchers, and advocates have received a grant from the Hewlett Foundation to fund a working group that studies the feasibility of making oral contraceptives available over the counter: as easy to purchase as aspirin. According to the reproductive-health think tank the Guttmacher Institute, nearly half of women will experience at least one unintended pregnancy by the time they're 45, and almost a third will have had an abortion. Part of the reason for this, those in the working group say, is that the barriers to birth control are simply too high.

"It's harder and harder to access contraception care if you want it, here in the U.S.," says Grossman, who is a senior associate at the nonprofit research organization Ibis Reproductive Health, which coordinates the Working Group. "Non-use of contraception is going up among people who don't want to be pregnant, especially among vulnerable populations, like poor women and women of color." The group's hypothesis is simple: If birth control were easier to access -- fewer medical gatekeepers, less inconvenience, and lower cost -- more women would use it. If more women used it, there would be fewer unintended pregnancies.

Fair enough. But is it safe? What effect would a switch to over-the-counter status have on poor women's access to the medication? And if women were no longer required to get birth control from their doctor, would they still go for their annual exams?

The pill has been exhaustively researched, and most doctors agree that it poses almost no risk of serious side effects for the vast majority of healthy young women. But estrogen (one of two main ingredients in most forms of the pill) can slightly increase risk of heart attack or stroke among older women who smoke and women who have high blood pressure, diabetes, and a handful of other conditions -- so doctors prescribing birth control have long screened for these conditions.

"I think the doctor's got to be a gatekeeper," says Michael Cackovic, an instructor of obstetrics and gynecology at the Yale School of Medicine. The doctor should "not necessarily decide who gets to be on the pill and who doesn't but [should] at least make sure patients understand the risk. I have prescribed [the pill] to patients that are smokers and over 40, but after we've had the conversation."

Grossman instead argues that a clearly worded and easy-to-understand label is enough to let women screen themselves. "If you go through the list of all of the medical conditions that can make pill use dangerous, everything on that list except for [high blood pressure] is information that we get from a woman's history -- from what she tells us," he says. "You don't need a doctor to determine whether you have them." As for blood pressure, "educating women and making that service available," in places like self-screening kiosks in pharmacies, might be a better approach than requiring a doctor's visit as a prerequisite, he says.

"I'm personally convinced that there are not safety issues in taking oral contraceptives over the counter," says Sharon Camp, president and CEO of the Guttmacher Institute and a member of the Working Group. "For most of the people in the reproductive-health field, the issue of safety is probably not the biggest one. It really is, will an over-the-counter product be affordable for women who now get low-cost or reimbursed drugs? That remains to be seen." Camp's concerns stem from an earlier fight for over-the-counter access to emergency contraception, also known as Plan B.

Most insurance plans -- including most state Medicaid programs -- only cover prescription drugs. So when the Federal Drug Administration (FDA) finally approved the Plan B switch in 2006, millions of women suddenly found that the medication was no longer covered. At the same time, without insurance companies to bargain it down, the price of the medication jumped from roughly $27 to as high as $50.

"If we don't address that, but [if] we make the pill available over the counter, we will have made it more accessible to women who already have good access to health care, and less accessible to women who don't," says Amy Allina, program director at the National Women's Health Network and a member of the Working Group.

The Guttmacher Institute recently released a policy brief that said that at least 4.2 million women use visits to publicly funded family-planning clinics as their primary source of medical care. Clinics like Planned Parenthood become what the brief called "safety net providers." What would happen if they disappeared? "You don't want to say that you're requiring women to come in and get pills on prescription as a way of forcing them to get health-care services," Allina says. "But if women aren't coming into the clinics otherwise, and don't get those services, that's not good for them and eventually could lead to the loss of the clinics."

Still, an application to the FDA to make the over-the-counter switch is more of a long-term goal than an immediate plan. Grossman is hoping for 10 years, and part of the goal of the Working Group is to identify all the outstanding questions and answer them with research. Before it would approve a switch, for instance, the FDA would require "labeling comprehension" studies, to make sure the average user would be able to understand the instructions on over-the-counter packaging. They would also perform "actual use studies" to see if women would follow the instructions in the real world. Some of the research is either ongoing or being planned. "One of the lessons that I feel like we learned from the long battles over emergency contraception at the FDA," Allina says, "[is] that, if we ask the kinds of questions that we may think are above and beyond what the FDA should require, but are the questions that people in the community are concerned about -- and we can answer them -- it makes it easier to get past the political opposition."

But the precautions may not even be necessary. The Obama administration's proposed overhaul of the health-care system might make for an entirely new playing field by the time enough research has been conducted to actually move the process forward. Perhaps, in 10 years, poor women will have affordable and accessible access to health care, leaving Working Group members and other reproductive-health advocates to weigh the proposal on its merits alone.

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