Analysis Contraception

What’s in a Label? Why the Package Insert for Plan B is Wrong… and Why It Matters.

Kelly Cleland

When you open up the box for your medication and unfold the package insert it all looks so...scientific. All of those chemistry diagrams, tables and warnings. You'd assume that labels for FDA-approved medications must be accurate and up to date, right? Think again.

This article is published as part of our 2012 Back Up Your Birth Control series.

When you open up the box for your medication and unfold the package insert it all looks so… scientific. All of those chemistry diagrams, tables and warnings. You’d assume that labels for FDA-approved medications must be accurate and up-to-date, right?

Think again.

The labels for the emergency contraceptive pill Plan B One-Step and its generic cousins, Next Choice and Levonorgestrel Tablets, do not reflect the most current evidence about how the product works. The Plan B One-Step label says:

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“Plan B One-Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium).”

This language was taken from the original Plan B label, approved in 1999, and reflects the understanding at the time of how Plan B might work. But the science has evolved considerably in the last 13 years.

Newer evidence, published since the Plan B label was approved, provides compelling evidence that levonorgestrel EC (LNG EC) works before ovulation, but not after. Two recent studies tested whether there might be an effect of LNG EC on the implantation of a fertilized egg. Together with over a dozen other studies on how LNG works, we now have strong evidence it has no effect on the implantation of a fertilized egg.

The two most recent studies included women coming to clinics for EC after unprotected sex, monitoring whether ovulation had occurred and recording which women took EC before ovulation and which took it after. In each study, none of the women who took LNG EC before ovulation became pregnant, but among those who took it on the day of ovulation or after, roughly the same number of pregnancies resulted that you’d expect to see with no use of emergency contraception. If LNG EC were effective in preventing implantation of a fertilized egg, the pregnancy rates for those women who took it after ovulation would surely be lower. (For the latest science on how EC works, read this statement from the International Consortium for Emergency Contraception and the International Federation of Gynecology & Obstetrics).

So why does it matter? The standard legal and medical definition of the beginning of pregnancy in the US is the implantation of a fertilized egg in the uterus. By that definition, even if LNG EC did interfere with implantation, it would not interrupt a pregnancy. But there have been aggressive efforts to legally define pregnancy as beginning with the fertilization of an egg, both at the state level in the United States (including a recent failed attempt in Mississippi to define a fertilized egg as a person, with full legal rights and protections) and in numerous cases in Latin America. Constitutional Courts in Ecuador, Chile, Argentina, Peru and Honduras have banned or severely restricted access to EC, based on the misunderstanding that LNG EC interrupts the implantation process. In many of these cases, the Plan B product label was offered as evidence. But a document that is based on incomplete or outdated science should not be offered as evidence of anything.

The intention of the FDA is to ensure that product labels include the most up-to-date science. An FDA guidance document for industry states:

“[O]nly reasonably well-characterized mechanisms should be described, and care must be taken to avoid speculative and undocumented suggestions of therapeutic advantages.”

The purported implantation effect of LNG EC is most certainly speculative, undocumented and not well-characterized. It is highly likely that the current evidence about how LNG EC works is sufficient for the FDA to approve a label change. But it is up to the company to request such a change – in the case of Plan B One-Step, Teva Pharmaceuticals.

For women who have had unprotected sex, and are holding out hope for a last chance to prevent pregnancy, LNG EC is an important option… and at this moment in history, at least one brand of LNG EC is available in most countries. But as it is currently written, the labels for LNG EC products are used to restrict access to EC for women who need it. Eventually, the label for the very product that women rely on to prevent pregnancy after sex might be the thing that makes LNG EC inaccessible. And that is why Teva, and all companies that market LNG EC products, should be invested in keeping their labels up-to-date.

Culture & Conversation Contraception

‘Carmichael Show’ Tackles Plan B Myths: ‘Stop Acting Like We’re Killing a Baby’

Cynthia Greenlee

It’s not the first time emergency contraception (EC) has made primetime, but NBC earns points for walking viewers through how to obtain and use EC, even if the episode conveys a mixed message about just how involved families should be in relatives' reproductive lives.

This piece is published in collaboration with Echoing Ida, a Forward Together project.

On the March 20 episode of NBC comedy The Carmichael Show, 20-something couple Jerrod (comedian Jerrod Carmichael) and Maxine (played by Amber Stevens West) have a “sexual accident”: The condom breaks.

That fictional contraceptive failure gives the show, now in its second season and already known for its lighthearted treatment of heavy topics, an entrée to counter notions that equate emergency contraception (EC) with abortion, distribute correct information about how EC works, and portray a Black family frankly discussing pregnancy options.

It’s not the first time EC has made primetime. For example, VH1 reality show Love & Hip Hop: New York cast member Tara Wallace has mentioned her use of Plan B several times, including during the show’s March 21 reunion. But NBC earns points for walking viewers through how to obtain and use EC, even if the episode conveys a mixed message about just how involved families should be in relatives’ reproductive lives.

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Shortly after Maxine and Jerrod discover their condom has ruptured, the two soon arrive at the conclusion that EC—sometimes called the “morning-after pill”—is their best bet. Neither wants a child right now.

Their discussion is sitcom-brief, and the couple maintains a respectful dialogue even as they mull over the prospect of an unintended pregnancy. Jerrod defers to Maxine’s wishes. She’s calm and has a plan: “I know we’re going to be fine, because we’re going to go to CVS and we’re going to get a Plan B pill.”

Jerrod replies: “You don’t know how happy that makes me. God, emergency contraception is always the answer,” suggesting that Jerrod is familiar with EC or may have had a partner use it before.

It’s a picture-perfect scenario with relatively little stress and a quick consensus. But perhaps Jerrod and Maxine are too ideal. Some studies show that young people struggle to find out information about EC. A study published in the March issue of the Journal of Adolescent Health found that among its sample of 13- to 24-year-old boys and young men, only about 40 percent had ever heard of emergency contraception. A 2014 survey from British sexual-health organization FPA found that 43 percent of girls and women ages 16-to-54 didn’t know where to get EC if they needed it. Education wasn’t a fail-safe way of getting EC information, though EC knowledge went up with age; only 17 percent learned about EC in school or college.

So Jerrod and Maxine may be in the sweet spot of young adulthood—where they are old enough to have obtained contraceptive knowledge, are mature enough to discuss it, have enough cash to pay for it, and are not too embarrassed to seek it out.

But before they can reach a nearby pharmacy, a sudden storm forces them to take shelter at Jerrod’s family home. His parents (played by David Alan Grier of In Living Color fame and longtime actress Loretta Devine) figure out something is amiss with their son and his live-in girlfriend. Jerrod reveals the news: The two young people are anxious because, just an hour before, they realized there was a slight possibility that they could be parents.

The announcement kicks mother Cynthia (Devine) into overdrive. Affectionate but controlling, she digs out her yellowing, decades-old wedding dress to woo the couple to the marital altar. She imagines aloud her joy at being a grandmother and the possible baby as a boy she’d name Jeremiah.

As the storm keeps the Carmichaels confined in their basement, the devoutly Christian Cynthia grows increasingly shrill as she begs Jerrod and Maxine not to “have an abortion.” When Jerrod’s former sister-in-law responds to Maxine’s SOS and arrives with her own Plan B stash, Cynthia grabs the pill, flushes it down the toilet, and tells Jerrod and Maxine that now they need a “Plan C.”

Both Maxine and Jerrod remain firm with Cynthia. Maxine states that a pregnancy doesn’t require marriage these days.

Most importantly, Jerrod refutes his mother’s anti-choice rhetoric and distinguishes between abortion and EC: “Ma, Ma, stop acting like we are killing a baby. We are not. We are killing the idea of a baby.”

It’s an awkward explanation that doesn’t do much to dispel Cynthia’s protests or challenge the language of “killing.” And given Maxine’s status as a therapist-in-training who favors talking things out in her trademark wonky, almost clinical way, it’s odd that The Carmichael Show doesn’t capitalize on the character’s dispassionate communication style to help its viewers understand what EC actually does.

Still, it’s probably too much to hope that a TV comedy get in the medical weeds and explain that EC works by stopping the release or implantation of an egg. EC prevents pregnancy from happening at all, whereas abortion ends an established pregnancy.

What’s most important is that the show conveys useful basic information about Plan B: that it must be used within 72 hours of unprotected sex for maximum effectiveness, that it’s available over-the-counter, and that it’s relatively inexpensive.

Indeed, it’s the cost—cited as around $40 on the show, though some EC brands can cost less or more—that fascinates his father, Joe. He echoes Jerrod’s sentiment that EC is a technological wonder; Jerrod had told Maxine, “I don’t care if they ever cure cancer, ’cause science has done enough. They cured pregnancy, and that’s a hard thing to do. It’s so amazing.”

For his part, Joe is learning about EC for the first time. “So this B plan, it stops anything before it gets started?” he asks. “Well, get out of here. How much does this scientific achievement cost? … 40 bucks? Man, something that amazing should cost like $7,000.”

Joe’s response opens the door for further discussion, and it’s not often that we get to see men, particularly Black men, on TV talk about their feelings on fertility and fatherhood. Joe admits that after hearing decades ago that Cynthia was pregnant for the first time, he drove around and cried in his pickup truck from simultaneous excitement and anxiety. His older son talks about his apparent low sperm count and his unfulfilled wishes to have children. And as Jerrod listens to this family free-for-all about whether he and Maxine should seek emergency contraception, he begins to think that maybe he doesn’t want children in the future, either. This revelation throws Maxine off guard because she knows that although a pregnancy is not a good idea now, motherhood is definitely on her bucket list.

While Maxine’s maternal aspirations temporarily ally her with Jerrod’s judgmental and difficult mother, it’s hard to know what the show’s producers intended when they made a contraception failure into a family affair. As Maxine and Jerrod beat back their family’s objections or answer questions, the viewer wonders if the point is that young people must know their bodies, their contraceptive options, and what’s best for them when loved ones disagree? That’s a message I can get on board with. Or is it that people like Cynthia, who eventually comes around and tells Jerrod she understands their choice, can be supportive of others’ reproductive decision making? That’s important as well.

Or is it that there should be more discussion about unintended pregnancy within families or more honest dialogue about planning the family you want?

If the producers wanted to instill that last message, I’m not convinced that having the family weigh in on a predicament like Maxine and Jerrod’s, in which the pair had already clearly come to a decision based on what works best for them, sends a message I want to hear.

With a family like the Carmichaels, viewers can see why Maxine wanted the Plan B to be hush-hush. Family influence is one thing. But that influence can become coercion, and flushing someone’s contraceptives down the toilet makes for plot tension on TV, but is undeniably un-funny in real life. And though the episode ended, it’s hard to imagine that, in an actual American family, the discussion would wrap up with such a neat resolution. The idea of an entire family weighing in on a couple’s contraceptive decision sounds more like a disaster than fodder for a laugh track.

CORRECTION: This piece was updated to clarify how emergency contraception works.

Commentary Politics

Yes, Progressives, There Is a ‘BernieBro’ Problem

Katherine Cross

Despite the testimonies of many who have been personally targeted by these individuals, a number of white leftist men have queued up to say that the whole situation is an exaggerated ploy manufactured by journalists in the pocket of Hillary Clinton.

For the past few months, would-be supporters of Sen. Bernie Sanders’ presidential campaign have been systematically harassing feminist and anti-racist activists who are even remotely critical of Sanders. These “BernieBros”—as they were originally dubbed, according to the Atlantic, by its associate editor Robinson Meyer—generally rely on two primary arguments. They claim that feminist concerns are a distraction from the work of “real” political change, and that voters and activists of color who raise questions about Sanders’ platform don’t know what’s good for them because Sanders represents the change they actually need. Eventually, Sanders himself responded to condemn the “bros,” saying “We don’t want that crap” in a CNN interview earlier this month.

And yet people still deny their existence, suggesting that Sanders was browbeaten into his declaration by a press corps running with a made-up story.

Despite the testimonies of many who have been personally targeted by these individuals, a number of white leftist men have queued up to say that the whole situation is an exaggerated ploy manufactured by journalists in the pocket of Hillary Clinton. The net effect of this, besides fomenting mistrust of harassment victims, is to absolve the left from any responsibility for its failings, and to pretend that our ideologies inoculate us from engaging in harm.

Recently, investigative journalist Glenn Greenwald doubled down on these ideas in an op-ed for the Intercept, arguing that the entire idea of “BernieBros” was constructed by Clinton supporters to scupper the Sanders campaign.

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Greenwald focused on trying to debunk the individual claims of harassment by writers like the New Yorker’s Emily Nussbaum, claiming that they were either exaggerating about the extent of it or misattributing abusive comments to Sanders’ supporters. He went on to suggest that “pro-Clinton” journalists cited each other’s thinly sourced claims about BernieBro harassment rather than verifying its existence.

Completely absent from Greenwald’s truculent analysis is any real discussion of the leftward critiques of the campaign from those who have found Sanders’ positions on racial and gender politics lacking for someone claiming to head a “revolution.” If he had included it, his article would’ve been impossible to write in its current form. He would have had to contend with a long history of anti-racist and feminist activists being antagonized by overly aggressive, mostly white Sanders supporters, going back far longer than Greenwald supposes—and the targets were not generally white women with press platforms, as he suggests, but often young activists of color.

No mention is made, for example, of the Black Lives Matter protests at Netroots Nation ‘15, which were aimed at Sanders, Gov. Martin O’Malley, and other presidential candidates for their lack of acknowledgement of police violence and mass incarceration; nor of the fact that Ta Nehisi-Coates, a radically minded writer and critic if ever there was one, criticized Sanders for not supporting reparations for slavery—and was inundated with BernieBros for his trouble, several of which he retweeted onto his Twitter timeline as evidence of a structural problem. One wrote: “Your credibility gone, you’ll forever be known as a #Clintonista/just another Village Idiot,” never mind Coates’ scathing critiques of Clinton’s support of carceral policies. Coates later told Democracy Now! that he is planning to vote for Sanders.

Nor is there acknowledgment of how tech journalist and legal analyst Sarah Jeong found herself swarmed by violently angry Sanders supporters after she tweeted criticism of Sanders’ record on race. Despite her position as a confirmed Sanders voter, the abuse—which included rape and death threats—became so noxious and torrential that Jeong had to lock her Twitter account. In his article Greenwald even cites Carl Beijer, a columnist for the Baltimore Post Examiner and one of the prominent leftist men ginning up and justifying harassment against her.

Jeong noted to Quartz that the elevated abuse she faced “is a foreseeable consequence” of people like Beijer “framing my harassment as a moral good.” One of Beijer’s comments on Twitter, posted in defense of a friend he claimed Jeong labeled a “shitposter,” read “you’re an unfunny bougie laughingstock & you failed the bar b/c you’re dumb.” His reply to Jeong’s general critiques of Sanders supporters (of which, I must remind you, she is one): “delete your account you bougie oaf.” I honestly didn’t think anyone used “bougie” as an un-ironic insult anymore.

The same genre of nonsense befell Jamil Smith, former editor at the New Republic, whose critical essay on Sanders was met with a flood of abusive derision that became outright racist. The now-deleted Twitter account of Portland4Bernie accused Smith of “race-baiting.”

Meanwhile, Elon James White, CEO of This Week in Blackness (TWiB!) Media, told the BBC: “I’ve gotten everything from ‘shill’, ‘paid infiltrator’, to flat out having somebody actually call me a N***** in the midst of this.” Imani Gandy, White’s co-host for the TWiB! Prime podcast and senior legal analyst for Rewire, has been facing an ongoing torrent of vitriol from Sanders’ supporters convinced she’s all but a paid-up Clinton staffer.

Even so, Greenwald maintains, “The reason pro-Clinton journalists are targeted with vile abuse online has nothing specifically to do with the Sanders campaign or its supporters. It has everything to do with the internet.”

First and foremost, this ignores the fact that most of the targets I’ve mentioned thus far are not pro-Clinton; they’re either undecided or equally critical of Clinton as they are of Sanders. But secondly, and even more importantly, if we think harassment is the inevitable consequence of online social interaction, it absolves us as individuals from doing anything about it. Even while admitting the abuse exists, Greenwald chalks it up to the inevitable actions of random trolls with no connection to any larger force in the world: the unavoidable waste product of online discussion. In a major article about abuse being faced primarily by women and people of color, Greenwald indulges in one of the most tired forms of apologia for harassment.

All this, in service of concocting a vision of a conspiracy against Sen. Sanders by plugged-in writers and journos who are secretly in the tank for Clinton. Apparently, it’s not harassment, it’s actually about ethics in journalism. Now where have we heard that before?

This rhetoric is by no means limited to Greenwald, however. An activist who spoke to Rewire on the condition that her name not be used described a sustained campaign of harassment and abuse by individuals in the progressive movement that began after Black Lives Matter activists protested at Netroots Nation last summer. Their actions shook up a presidential forum featuring Sanders and Martin O’Malley, provoking dismissive and bewildered reactions from the mostly white crowd, some of whom saw the Black Lives Matter protesters as “ungrateful” for Sanders’ putative radicalism. This was the immaculate conception of the toxic Sanders supporter, who continued to resurface through tweets and social media personas for months.

“Even raising questions is seen as a ‘coordinated attack’ on Sanders’ candidacy or all Sanders supporters,” the anonymous activist said. “These are not just Twitter eggs being annoying on public social media. These include prominent figures who are doing and saying abusive things elsewhere.”

Responses like Greenwald’s, she said, are “infuriating and galling. The victim-blaming is off the charts. Why is it so hard for them to accept that there are problematic people in their tribe?”

“If they care about the progressive movement, this is a terrible move,” she said. “Denying the existence of BernieBros is not helpful to the campaign. It’s shitting on victims. How dare they accuse victims of faking the harassment, being oversensitive, or confusing Republican fakers with Sanders supporters?”

“To their credit, Sanders campaign people are finally acknowledging the problem,” she said. “BernieBro ‘truthers’ aren’t helping them, and that’s also a disservice to all the Sanders supporters who are wonderful and thoughtful.”

“This should be irrelevant, but I’m not even backing either candidate yet,” she continued. “I’m ambivalent about both, although like most Dem voters, I would be happy with either candidate as the nominee. And no, I’m not on the payroll of any campaign or related organization. I just want the abuse to stop.”

Feminist writer Sady Doyle, who is an open and proud Clinton supporter, has also received a great deal of abuse for her trouble. Last week, she wrote with characteristic insight about progressivism’s longstanding inability to tolerate women who speak forthrightly on gender politics. She links the “BernieBro” phenomenon to the fact that progressive men prefer to focus on political struggles that do not personally implicate them, like class issues:

I don’t need to look to Bernie Sanders himself for the question of whether feminism is part of progress. I can get the answer when a young man who calls himself a “secular progressive, against bigotry of all kinds,” with a picture of Bernie Sanders as his banner image, Tweets to call me a “regressive feminazi,” and an example of “sheer female ignorance.” I can get the answer when Shane Ryan angrily asserts that sexism has no influence on this election, that any attempt to address or analyze sexism aimed at Hillary Clinton or her supporters is just an attempt to “turn the discussion away from the political, and toward the personal,” and that sexism, in fact, is not political at all: “Talk about sexism, and at the very least you aren’t talking about politics,” he writes.

This is the crux of the issue, I’d say, and why this is much bigger than Sen. Sanders or the 2016 election. For progressive and leftist men, class politics (and, occasionally, the politics of Western imperialism) often trumps all else, rendering them unwilling to see an intersectional approach as anything other than a narrow-minded distraction. To them, class politics are the fulcrum upon which all oppression is balanced. As they see it, if one were to knock out that fulcrum, all else will come tumbling down—never mind what happened in the Soviet Union.

As long as they pursue this political aim, nothing else matters to the same degree: not rape, not sexual assault or harassment, not the devaluing of women’s work, not online harassment’s unequal impact on women or people of color, not police violence, not de facto segregation or the erosion of voting rights legislation, not abortion, not forced sterilization.

There are a few things that must be said, however. First and foremost: “BernieBro” is a terrible term. For one thing, it obscures a dynamic where white women who support Sanders harass Black critics of all genders. Its jokey tone is also unequal to the seriousness of what it describes. There can be no doubt that the term creates confusion, and it has been deployed in ways that suggest it refers to all Sanders voters, which is both counterproductive and does violence to any empirical understanding of what’s happening here. Remember, this often involves Sanders supporters attacking their own.

Furthermore, it is equally true that Hillary Clinton and her more prominent backers have come to use a very reductive view of feminism in a toxic fashion, one that overwhelmingly centers the experiences of white women. We’ve just come off of a week where former Secretary of State Madeline Albright suggested that women who didn’t support Clinton were among those “going to hell” for not helping other women, and veteran activist Gloria Steinem argued that young women broke strongly for Sanders because “that’s where the boys are” (she followed this up by sharing a few transphobic chuckles with Bill Maher). To say this fell flat with young women—myself included—is an understatement.

Analyzing the origins of this nonsense merits a fuller discussion, some of which is thankfully being had elsewhere. Writer and activist Mikki Kendall, for instance, sees a correspondence between the racist rhetoric that mushroomed around Clinton’s campaign in 2008 and the millennial-baiting that’s now occurring. There is an unwillingness to admit the fact that young women are making genuine arguments against both the implications of such gaffes and the compromises Clinton herself has made throughout her career—supporting war, drone strikes, tough-on-crime policies, accepting the donations of America’s super-rich, and so on.

Clearly, Sanders supporters are not the only ones being reductive, nor are they the only ones refusing to prioritize issues in their support that affect people of color.

But it is important to point out that this does not cancel out or justify the ongoing problem with toxic Sanders supporters and the longstanding leftist faultline it reveals. Leftism harbors many an anti-feminist, and more than a few people who see movements like Black Lives Matter as an anti-revolutionary distraction. These individuals sneer at people for “voting against their interests,” a line used against Black critics of Sanders so frequently that New York Times columnist Charles M. Blow recently inveighed against the phenomenon, which he amusingly dubbed “Bernie-splaining.” Even I have had Sanders supporters tweet “but did you know he marched with MLK?” at me in earnest, after I suggested that the senator should keep improving his racial politics.

The people who throw around “bourgeois” and “liberal” as an insult to any political ethic or idea they dislike; who clamor for a violent revolution that never takes into account the needs of the actual working class or, say, people with disabilities; the folks who think that classism is the one oppression to rule them all; who think sneering at Walmart shoppers is radical praxis? They are an issue that will remain with us long after 2016 has come and gone. In the meantime, however, allowing the narrative of “rich white Clintonista journalists are inventing BernieBros” to go unchallenged merely contributes to a culture of disbelief and silencing around both the issue of online harassment and white, male hegemony in leftist spaces.

It has not escaped my notice, after all, that the people getting hit hardest by these waves of abuse aren’t white men. That means something we should be paying attention to.