On Plan B: a Dart for Dr. Manny

A physician toes the party line on emergency contraceptives, and science takes a hit

Leave it to Fox News Channel’s Dr. Manny (Alvarez) to scare the audience away from open and honest discussion about emergency contraception. In his April 5 column on foxnews.com, Alvarez, FNC’s senior managing editor for health news, characterizes the recent court order to make Plan B One-Step available over the counter for women of all ages as “highly dangerous.”

Is it? Now, if all you watch and read is Fox, you are terrified, and left with little reason to learn more about this ruling, this issue, or this product. (You likely also wouldn’t know that Fox used images of the wrong product in its April 5th broadcast, too. While reporter Julie Banderas spoke about the relevant “Plan B One-Step” product, B-roll of an older two-pill version of Plan B ran on the split screen. This is important because Alvarez and other outspoken opponents argue that young women can’t understand how to use Plan B One-Step safely. It’s pretty simple, though: You take a single pill within three days of unprotected sex.)

To help clarify the situation, here are brief summaries of the ruling, the issue, and the product, brought to you by extensive—and mostly balanced—national media coverage:

The Ruling

Back in 2009, Margaret Hamburg, the commissioner of the Food and Drug Administration (FDA), recommended making Plan B One-Step available to women of all ages. She agreed with the agency’s Center for Drug Evaluation and Research that the pill was that “safe and effective and should be approved for nonprescription use for all females of child-bearing potential.” In late 2011, though, Kathleen Sebelius, the Health and Human Services Secretary, overruled the recommendation, a decision she defended as based on science but “widely interpreted as political,” as The New York Times put it, “because emergency contraception had become an issue in the abortion debate and allowing freer access for adolescents would prompt critics to accuse the president of supporting sexual activity for girls of that age”—this in the middle of the election campaign.

But last week, a federal judge vacated Sebelius’s decision, in rather strong language:

“The decision that the agency was forced to make, contrary to its own policies and judgment, is not entitled to any deference. Indeed, it is hardly clear that the Secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.”

Until the judge ruled, Plan B had been available without a prescription to women 17 and older. As with Sudafed, they just had to ask for it from the pharmacy. It was available only by prescription to those 16 and younger. But now that Sebelius’s heavy hand has been slapped, the FDA has 30 days to make any brand of emergency contraception—or only Plan B One Step, if it chooses—available without a prescription on pharmacy shelves, like Tylenol or Band-Aids.

The administration can appeal the ruling, and the Justice Department, according to NPR and numerous other reports, released a statement saying it is “reviewing the appellate options and expects to act promptly.”

The Issue

The fight to bring Plan B out from behind the pharmacy counter and out to the open shelves has been going on for more than a decade. It has always involved consumer and professional medical groups, the manufacturer, the FDA, and the White House (both under the Bush and Obama administrations). Recent coverage by Reuters, The Washington Post, The Christian Science Monitor, and The Wall Street Journal offer succinct but thorough explanations of the cascade of regulatory and legal milestones. The Chicago Tribune ran a great timeline based on the Reuters piece and additional reporting.

The Product

Misinformation about Plan B and other emergency contraceptives is everywhere. This has helped propagate the fallacy that emergency contraceptives are the same as abortion-inducing drugs, such as RU-486. And, in turn, misinformation has helped groups in opposition to wider access of Plan B appeal to their base.

Plan B is nothing exotic. It is simply a higher dose of levonogestrel, the same hormone used for regular birth control pills and works similarly. It prevents pregnancy by preventing or slowing ovulation or by preventing a fertilized egg from implanting in the uterus. Researchers emphasize that this is its primary mechanism of action, but make mention of the remote possibility that it may also prevent implantation of a fertilized egg.*

Other, and perhaps more sinister, misinformation concerns Plan B’s safety and efficacy. Opponents love to scare the public into thinking the drug causes serious side effects that can cause long-term harm to women and their fertility. Here’s Alvarez’s take:

There are side effects with Plan B, which include nausea, headaches and menstrual changes. While menstrual change in a 13- or 14-year-old girl is very common, if you introduce Plan B into the equation, it could make the effects even worse. Plan B can stop a period from happening all together, or prompt a lengthy menstrual cycle—which has complications unto itself.

Most people don’t consider nausea, headaches, and menstrual changes to be “highly dangerous” side effects and neither does ACOG, the American Congress of Obstetricians and Gynecologists. And amenorrhea—the absence of menstruation—can be associated with plenty of other conditions common to young girls and teenagers, including athletics-induced estrogen depletion.

Alvarez also disregards the fact that this isn’t just about pre-teens or teenagers; it’s about all women of reproductive age. Just ask Susan Wood, the FDA official who, in 2005, resigned her post in disgust over the Bush administration’s kicking the can down the road on this issue. She described an experience in a Washington Post Wonkblog Q&A on April 6th in which she (not a teenager) tried to find a pharmacy on a Saturday night where she could show proof she is over 17 and buy Plan B.

To get this product I had to travel to three pharmacies, embarrass myself, get carded, and meanwhile at all three places I didn’t need the pharmacy to be open to buy condoms, spermicide or a pregnancy test.

Inhibiting informed discussion of emergency contraception inhibits ways to help girls and women use it safely and effectively. As Susan Wood explains, the FDA can require manufacturers to change product labeling to include explicit, easy-to-understand instructions and recommendations for parental, physician, nurse, or pharmacist consultation. (Pharmacists, not to be overlooked, are trained in patient consultation for all kinds of products, both Rx and OTC. Emergency contraceptives are no different.)

Alvarez’s outrage continues:

I mean, a school nurse can’t even give an aspirin without parental consent, and yet a federal judge says it’s okay for a 13-year-old to get emergency contraception without anyone saying anything about it? That’s absurd.

While he’s on the subject of aspirin, where’s the outrage? Here are some common side effects: nausea, vomiting, irritation of the stomach lining. And some less common aspirin side effects: ulcers, seizure, anal bleeding, and death. Aspirin is available to 13-year-olds who can buy it and other drugs in the pharmacy whenever they want. Any ER nurse or physician will confirm that there are infinitely more overdoses of aspirin, Tylenol, and Benadryl than there are of contraceptives, emergency or otherwise.

* Correction: In the original version, this piece said Plan B works either by slowing ovulation or by preventing a fertilized egg from implanting in the uterus. Further reporting—prompted by a sharp-eyed reader—shows that researchers believe that preventing implantation is only a remote possibility as a secondary way the pill works. We regret the error.

Sibyl Shalo Wilmont covers healthcare policy issues for The Second Opinion, part of CJR’s politics and policy desk, the United States Project. Follow the project’s work on Twitter @USProjectCJR and follow her @nursesibyl.

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Sibyl Shalo Wilmont is a healthcare journalist and emergency department nurse with insider experience in the pharmaceutical industry, academic medicine, and patient advocacy. She is a graduate student in Hunter College's dual-degree Master's in Community/Public Health Nursing/Master's in Public Health program. Follow her on Twitter @nursesibyl. Tags: , , ,