Fight Birth-Control Battle Over the Counter

Bloomberg View , March 07, 2012

Anyone—a local teenager, a traveling businessman, a married mother of four, an illegal immigrant, even a student at a Jesuit university—can walk into my neighborhood CVS any time, day or night, and, for less than $30, buy a 36-count “value pack” of Trojan condoms.

That’s enough to last most Americans at least three months, according to Kinsey Institute surveys. If you want more, you can buy out the store’s entire stock. There’s no limit, and you don’t need to see a doctor for permission and a prescription.Contrary to widespread belief, there’s no good reason that oral contraceptives—a far more effective form of birth control—can’t be equally convenient.

True, making the pill available over the counter could reduce the amount of outrage and invective available for entertaining radio audiences, spurring political fundraising and otherwise amusing the American public. But the medical risks are quite low.

Partly because birth-control pills are available only by prescription, people tend to think they’re more dangerous and less well understood than they actually are. In fact, “more is known about the safety of oral contraceptives than has been known about any other drug in the history of medicine,” declared an editorial in the American Journal of Public Health back in 1993. That editorial accompanied an article arguing for over-the-counter sales.

Unlike most medications, the article noted, birth-control pills require no medical diagnosis: “A woman herself determines her need for oral contraception; she assesses her own risk of pregnancy...and the costs and benefits of both pregnancy and alternative contraceptions.” Nearly two decades later, birth- control pills look even safer than they did then, and recent research indicates that women are both able and eager to manage their own purchase decisions.

Requiring a prescription “acts more as a barrier to access rather than providing medically necessary supervision,” argues Daniel Grossman of Ibis Reproductive Health, a research and advocacy group based in Massachusetts, in an article published in September in Expert Review of Obstetrics & Gynecology.

Birth-control pills can have side effects, of course, but so can such over-the-counter drugs as antihistamines, ibuprofen or the Aleve that once turned me into a scary, hive-covered monster. That’s why even the most common over-the-counter drugs, including aspirin, carry warning labels. Most women aren’t at risk from oral contraceptives, however, just as most patients aren’t at risk from aspirin or Benadryl, and studies suggest that a patient checklist can catch most potential problems.

To further increase safety, over-the-counter sales could start with a progestin-only formulation, sometimes called the “minipill,” rather than the more-common combinations of progestin and estrogen. (Although we casually refer to “The Pill,” oral contraceptives actually come in about 100 formulations.)

Progestin-only pills, or POPs, have fewer contraindications. Unlike combination pills, they’re OK for women with hypertension, for instance, or smokers over the age of 35. The main dangers are fairly rare conditions such as breast cancer or current liver disease. “Not only are POP contraindications rare, but women appear to be able to accurately identify them using a simple checklist without the aid of a clinician,” declares an article forthcoming in the journal Contraception.

Aside from safety, the biggest argument for keeping birth- control pills prescription-only is, to put it bluntly, extortion. The current arrangement forces women to go to the doctor at least once a year, usually submitting to a pelvic exam, if they want this extremely reliable form of contraception. That demand may suit doctors’ paternalist instincts and financial interests, but it doesn’t serve patients’ needs. As the 1993 article’s authors noted, the exam requirement “assumes that it would be worse for a woman’s health to miss out on routine care than it would be to miss out on taking oral contraceptives.”

Going to the doctor is costly in time, money and sometimes in dignity. Not surprisingly, the prescription requirement deters use of oral contraceptives. In a 2004 phone survey, 68 percent of American women said they would start the pill or another form of hormonal birth control, such as the patch, if they could buy it in a pharmacy with screening by a pharmacist instead of getting a doctor’s prescription. Two-thirds of blacks and slightly more than half of whites and Latinas surveyed said they chose their current, less-effective method of birth control because it didn’t require a prescription.

Right now, the American women who have the most choice are those who live near the border with Mexico, where pharmacies sell oral contraceptives without a prescription, generally for about $5 for a one-month supply. A group of researchers including Grossman have conducted extensive interviews with more than 1,000 women who live in El Paso,Texas. Roughly half the women get birth-control pills from local clinics, often free, while the other half go across the border to pharmacies in Ciudad Juarez. The researchers find, not surprisingly, that those who cross the border have more ties to Mexico; 77 percent were born there, compared with 60 percent of clinic users. But there are also differences in priorities.

“Among pharmacy users, very large percentages noted both not having to go to a doctor to get a prescription and being able to send a friend or relative to pick up their pills as advantages of Mexican pharmacies,” the researchers write in a June 2010 article in the American Journal of Public Health. Clinic users, on the other hand, cite low cost and the availability of other health services.

In addition, the authors note, for many clinic users crossing the border to buy contraceptives “was neither convenient nor free of risk; more than half expressed a fear of being stopped by US customs upon their return.” Nonetheless, Grossman notes in an e-mail, the research “showed that US resident women are interested in OTC access when it’s convenient and available at a reasonable price.”

One result from the El Paso study surprised researchers. “Women who got the pill in clinics were significantly more likely to stop using it during the study—even though they still didn’t want to get pregnant,” Grossman says. That’s a big deal. In fact, he says, “my hope was that we would show that continuation was no worse for the OTC group, but in fact we showed it was better.”

This suggests that having to see a doctor to get a prescription renewed really does drive women away from oral contraceptives. “People rarely tell you, ‘I ran out and I was too lazy to get my prescription renewed,’” says Joseph Potter, a University of Texas demographer who worked on the El Paso research. “They say they quit because of side effects.” But the problem isn’t really laziness or, for that matter, out-of- pocket expense. It’s all the things that get in the way. Potter recalls an airplane conversation with a department-store executive who said that poor women weren’t the only ones to quit the pill because they couldn’t get to a doctor. She’d done the same thing, because she was busy.

The real question now isn’t whether allowing over-the- counter sales would benefit women and prevent unwanted pregnancies—the evidence is overwhelming that it would—but whether any pharmaceutical maker wants to change the status quo. For a pill already approved by the Food and Drug Administration for prescription sales, getting over-the-counter approval would require an estimated $10 million to pay for new studies. And, of course, there would be huge marketing costs to establish the new brand.

The company best positioned to make the switch is probably Johnson & Johnson, Its McNeil Consumer Healthcare division, most famous for Tylenol, has lots of experience marketing formerly prescription-only products, including Nicorette, Motrin and Pepcid. Most important, its drug Ortho Micronor is one of the few progestin-only pills already registered with the FDA. (Minipills are more common in Europe, but moving one of those drugs to the U.S. would require millions more in regulatory expenses just to get approval for prescription sales.)

Will J&J or another company take a chance on creating the Advil of oral contraceptives -- making a prescription product a touchstone consumer brand? Are there public policy changes that could encourage the switch? If you’re actually interested in preventing unwanted pregnancies rather than merely scoring political points, these are the questions you should be asking.