Archive for the ‘Birth Control & Family Planning’ Category

April 3, 2014

Smoke and Mirrors and Women, Oh My

by Katherine L. Record

Last week, the Supreme Court attracted lots of attention when it heard arguments about whether a corporation can exclude mandatory preventive benefits from its employee health plan, based on a religious objection to certain types of healthcare.

This is a tale as old as time; religion has long been the basis for opposition to reproductive (i.e., women’s) health – including the preventive healthcare now in question, contraception.

Yet this argument has nothing to do with government infringement on the practice of religion.

In fact, the corporation, Hobby Lobby, covered two of the four contraceptive devices in dispute until its lawyers were actually arguing the issue in court, apparently to little detriment to the company’s faith in God. What’s more, Hobby Lobby’s 401(k) includes more than $73 million invested in the companies that produce these objectionable contraceptives (e.g., intrauterine devices, emergency contraception).

This has not stopped Hobby Lobby from arguing that the Affordable Care Act (ACA) is threatening its freedom, as a corporation, to practice religion.

This is a clever argument. We take religious freedom seriously, as we should. Masking coverage of FDA-approved contraceptives, as the ACA requires, as an infringement on faith is catchy. Nonetheless, it is nothing more than smoke and mirrors, which we, as attorneys, have a knack for creating.

Practicing law is often a matter of distilling a problem into sterile elements and stringing them together to form a line of reasoning that favors a given conclusion. Generally, this allows judges to apply the law with an even hand, no matter how complicated life gets.

Yet it also allows us to paint an issue as something it is not. This is particularly problematic when the issue is inequality, a concept lawyers have masqueraded for years (justifying slaves as property, segregation, limited voting rights, a narrow definition of marriage).

Last week we did it again.  Here’s the picture Hobby Lobby painted:

The ACA’s requirement that most health plans cover preventive services, including all FDA-approved contraception, violates the Religious Freedom Restoration Act of 1993 (RFRA). RFRA is a federal law that bars Congress from enacting a law that substantially burdens religious practice, even if it generally applies to all faiths, which passes muster under the First Amendment. In other words, RFRA creates more robust protection of religious freedom than the First Amendment.

Let’s break it down:

(1) RFRA protects the corporation’s right to practice religion just as it does a person’s right to practice (i.e., a corporation is a person, which is the case under the First Amendment, but has never been treated as such under this federal law);

(2) covering certain types of contraception substantially burdens this corporation’s religious practice; and

(3) the government does not have a compelling interest that justifies this insufficiently narrowly tailored intrusion into the company’s faith.

Sounds good, right?

It did to the Court. Last week, the attorney representing the United States and the Justices of the Court focused on this argument just as Hobby Lobby painted it, waxing poetic on statutory interpretation, principles of corporation law, the distinction between for-profit and non-profit tax status, and the intention of Congress as it existed in 1993 – when it enacted RFRA to protect a “person’s” right to religious practice.

All of this is irrelevant.

The legal profession is being dishonest by cloaking the real issue in legal doctrine. Hobby Lobby paints contraceptives as the Scarlett letter of the ACA, alleging that coverage of some types disrupts their Christian faith. Yet the ACA requires coverage of all FDA-approved contraception to protect women’s health – not to promote sex that does not produce offspring. In fact, 98% of sexually active Catholic women use contraception, yet the Catholic Church marches on.

As it turns out, healthcare is healthcare, even if you have a uterus.

Women who do not space out pregnancies are at higher risk for adverse outcomes – both for the mother and the child. Women who get pregnant accidentally – whether unintentionally or unwillingly, are more likely to give birth prematurely, to develop depression, to avoid prenatal care.

Moreover, some women require contraception for reasons entirely unrelated to conception (e.g., amenorrhea or menstrual irregularities, fibroids, endometriosis). And not all women can take the kind of contraception Hobby Lobby deems pious (e.g., an intrauterine device can be medically necessary if a woman cannot take the pill).

In short, women and children are healthier when medically indicated contraception is available – which is why contraception is a healthcare benefit. Requiring companies to offer the same level of healthcare to both female and male employees does not impede religious autonomy, it keeps the workforce healthy.

In June, the Supreme Court will issue a ruling couched in terms of religious autonomy. Yet it will not affect religious practice, Hobby Lobby’s or otherwise. Rather, the Court will determine whether an employer can charge women more than men for preventive services (i.e., provide comprehensive coverage for men and partial coverage for women). In other words, the Court is once again considering equality, masqueraded as a religious threat.

Are women sufficiently person-like to access the same degree of medical coverage as men? The Court very well might say no.

Fortunately, the law is not a foregone conclusion. Indeed, over time, the Court has reversed itself on matters once considered predetermined by our forefathers (e.g., the federal ban on gay marriage, criminalization of sodomy, and the status of black persons as, well, persons). Women might not be equal to men quite yet, but there is hope.

Katherine L. Record is the Senior Fellow at the Center for Health Law and Policy Innovation (CHLPI) at Harvard Law School and a member of the Our Bodies Ourselves board of directors. This post was previously published on Harvard Law School’s Petrie Flom Center Bill of Health blog.


March 28, 2014

Why Contraception is a Health Issue for Everyone

Photo “ritual” by Monik Markus used under CC BY-2.0 from https://flic.kr/p/8YaubV

Some of the media coverage of Tuesday’s arguments before the Supreme Courton the contraception mandate tended to pit women’s rights activists against social conservatives, making contraception seem like a lifestyle choice that only benefits some women — you know, the ones who have sex.

What often gets lost in the debate is why contraception is considered a preventive health issue — and why treating it as such is beneficial for everyone.

During the healthcare debate, the Department of Health and Human Services charged the Institute of Medicine (IOM) with reviewing preventive services that are important to public health and well-being, and recommending which ones should be considered in the development of comprehensive guidelines.

IOM came up with this evidence-based list of preventive services for adults and children, all of which are now covered by insurers with no required co-payment. Take a look at the IOM report, which explains the selection process.

For women, this includes annual well-woman visits, testing for STIs and HIV, support for breastfeeding, and screening and counseling for domestic violence.

It also includes FDA-approved contraception methods, as well as patient education and counseling on contraception. What makes contraception a health issue? Well, with all due respect to Mike Huckabee, it’s not about women’s libidos.

Here’s the deal: When women use contraception, they can avoid unwanted pregnancies and space planned pregnancies to promote optimal birth outcomes.

When a pregnancy is planned, women can start prenatal care, including increasing their intake of folic acid; work with their healthcare providers to address relevant medical conditions, as well as substance abuse; and take other steps that lead to healthier outcomes for both the mother and the infant.

Pregnancies that are unplanned are more likely to be affected by delayed prenatal care, maternal depression, low birth weight, poorer childhood physical and mental health, and other complications. Breastfeeding rates are also lower after unintended pregnancies.

Social conservatives should also take note that 40 percent of unintended pregnancies end in abortion. And there is an economic cost: Two-thirds of unintended pregnancies are paid for by publicly funded insurance programs, usually Medicaid. For more information, Guttmacher Institute has a terrific fact sheet on unintended pregnancies that explains the incidence rate, demographics, outcomes and costs.

When you look at the facts, contraception is smart public health policy.

Of course, for some women, birth control is essential for other health reasons, including acne, fibroids, endometriosis and to reduce problems associated with irregular or very heavy periods.

Despite the proven health benefits — and the benefits to society as a whole — Hobby Lobby and Conestoga Wood claim that the requirement to provide health insurance that includes no-cost contraception violates their religious freedom.

Not surprisingly, the Court’s three female justices were most skeptical of their position. As Jeffrey Toobin writes in The New Yorker:

After Paul Clement, the lawyer for Hobby Lobby, began his argument, twenty-eight of the first thirty-two questions to him came from Ruth Bader Ginsburg (four questions), Sonia Sotomayor (eleven), and Elena Kagan (thirteen). The queries varied, of course, but they were all variations on a theme. The trio saw the case from the perspective of the women employees. They regarded the employer as the party in the case with the money and the power. Sotomayor asked, “Is your claim limited to sensitive materials like contraceptives, or does it include items like blood transfusion, vaccines? For some religions, products made of pork? Is any claim under your theory that has a religious basis, could an employer preclude the use of those items as well?” Clement hedged in response. When Clement asserted that Hobby Lobby’s owners, because of their Christian values, did care about making sure that their employees had health insurance, Kagan shot back:

“I’m sure they want to be good employers. But again, that’s a different thing than saying that their religious beliefs mandate them to provide health insurance, because here Congress has said that the health insurance that they’re providing is not adequate, it’s not the full package.”

At Talking Points Memo, Sahil Kapur wrote:

The most forceful was Justice Elena Kagan, who repeatedly asked aggressive questions throughout the 90-minute argument about the legal dangers of exempting certain entities from laws on the basis of religion.

“There are quite a number of medical treatments that religious groups object to,” she said, positing that a ruling against the Obama administration could empower business owners to seek exemptions from laws about sex discrimination, family leave and the minimum wage. “You’d see religious objectors come out of the woodwork,” Kagan warned, arguing that it’s problematic for judges to test the centrality of a belief to a religion or the sincerity of beliefs that are invoked in court.

Much of the argument also centers around whether companies really have religious freedom, or if that really only applies to people — whether corporations count as “people” has been a major issue before the Court in the recent past. In “The Hobby Lobby Case Represents The Worst Kind Of Anti-Choice Arrogance,” Sarah Erdreich writes:

But even if the owners do have a religious commitment, Hobby Lobby is not pretending that it is a religion. It is a business. That any business should have power over what can literally be the life-and-death health decisions of its employees, well, that’s another issue for another day. But as long as Hobby Lobby sells its supplies to saints and sinners alike, it has no business questioning what its employees do when they go to see the doctor.

Access to birth control is important for everyone — for preventing pregnancies, and to allow women and families to best time and plan healthy pregnancies. Hopefully the male members of the Supreme Court will see it that way, too.

To catch up on the issue, check out this coverage:


January 17, 2014

The Real Danger of the NuvaRing

If you read the recent Vanity Fair article about NuvaRing contraception, “Danger in the Ring,” you could be excused for coming away with the conclusion that NuvaRing is deadly and should be yanked off the market immediately.

But hold on.

NuvaRing, a hormonal birth control that is inserted into the vagina, contains estrogen and etonogestrel, a form of progestin that’s different from what’s in the most common low-dose combined birth control pills. As the Vanity Fair article describes, it is also the subject of ongoing lawsuits about dangerous blood clots.

Marie Brenner’s article focuses heavily those lawsuits alleging harms from the device. What it doesn’t do is put the risk of harms from NuvaRing in the context of other hormonal birth control options, or discuss real magnitude of risk of any of these options.

All hormonal birth control with estrogen carries some risk of blood clots. These are referred to as venous thromboembolism, or VTE, and can be fatal. The risks of the most common combined oral contraceptives are quite small.

The latest FDA safety announcement (2012) estimates that for every 10,000 women taking birth control pills over the course of one year, between three and nine cases of blood clots may occur. In fact, the risks are thought to be higher during pregnancy (five to 20 cases per year for every 10,000 women), and much higher right after birth. By comparison, among non-pregnant women who do not take birth control pills, the number of cases per year ranges from one to five.

Some types of birth control, such as the newer types of pills (like Yasmin and Yaz) containing the progestin drospirenone, are thought to cause a greater risk. These pills have come under more scrutiny in Europe and the United States, with Europe taking a more active role in reviewing the risks. Some women’s health advocates, including Our Bodies Ourselves, have questioned allowing these newer pills to remain on the market because they pose a greater clot risk without offering any major benefits over older types of pills.

The factors to consider when weighing the risks and benefits of NuvaRing or other non-pill alternatives may be different, however, because non-pill alternatives offer more convenience and less chance of missing a dose.

Part of the problem in determining what’s “best” for any individual is the lack of clarity surrounding the increased risk that comes with using NuvaRing. Indeed, different studies have yielded different results: A BMJ study included in the Vanity Fair article found about a 90 percent increase in risk; a FDA paper reports a 56 percent increased risk; other studies have reported “similar” rates of venous thromboembolism between the ring and the regular oral contraceptives.

Looking at the BMJ study, which seems most alarming, lets consider the actual numbers. The researchers explain a 90 percent increased risk would result in 7.8 incidents of VTE per 10,000 exposure years. That means, for example, if 1,000 women each used NuvaRing for 10 years, there would be about 8 incidents of VTE among them in that decade (1,000 women x 10 years = 10,000 exposure years).

So, while different methods of hormonal birth control carry different levels of risk, in general hormonal birth control is very safe for most women. Of great concern, however, is that women aren’t given this information to help in their decision-making.

recent article in Huffington Post describes the FDA approval process for NuvaRing and alleges that Organon — the company that made NuvaRing, which pharmaceutical giant Merck now owns —  maneuvered to keep clot risk information off the product label. To date, the NuvaRing label does not feature the same “black box warning” that the birth control patch carries, which notes a higher risk than the pill. Instead, the NuvaRing product label simply notes that smokers who use the ring may have “serious cardiovascular events.” The NuvaRing website does include some information on comparing the risk to combined oral contraceptives, but the FDA-approved label does not make this as clear by not including it in the black box warning that carries the most important safety information.

Cindy Pearson, executive director of the National Women’s Health Network, and a strong advocate for close review of drug safety, has responded to the concerns:

The most heartbreaking part of the Vanity Fair article are the accounts of women who never knew that the contraceptive ring was delivered a higher dose of hormones and is slightly more risky than pills. No clinician should offer women these products without fully disclosing the risks, and encouraging women to try alternative, safer forms of contraception if they haven’t already done so.

Agreed. While the risk to an individual woman may be low with any of these birth control methods, women must be informed that newer options — including the ring, the patch, and the newer pills — may be more risky than older-style combined oral contraceptives.

In addition, health care providers need to stay on top of the evidence, and should make a point of discussing the benefits and the risks. All women should have the information they need to make good choices for their own health.

Related: Hormonal Contraception and Heart Risks


December 3, 2013

Science Says: Emergency Contraception Does Not Block Implantation of a Fertilized Egg

Last week, in a post about how some types of emergency contraception are less effective or ineffective in women weighing more than 165 pounds, we mentioned that the European equivalent to Plan B One-Step was getting a new label that will note the problem.

Let’s take a look at the other reason for the label change: European health officials have determined — and want to make clear — that the drug “cannot stop a fertilized egg from attaching to the womb.”

This is a big issue, as abortion opponents have long opposed EC on the grounds that it might prevent a fertilized egg from implanting in the uterus. U.S. labels of levonorgestrel-containing emergency contraceptive pills, such as Plan B, don’t directly refute the possibility.

But as The New York Times noted last year, recent science suggests that this is not the case; the pills work only by preventing ovulation and fertilization.

Last week, NYT reporter Pam Belluck noted how the FDA and other health agencies responded to the scientific studies:

References to the possibility of blocking implantation were then removed from the websites of the National Institutes of Health and the Mayo Clinic. And an F.D.A. spokeswoman, Erica Jefferson, said that “the emerging data on Plan B suggest that it does not inhibit implantation.”

On Tuesday, Ms. Jefferson reiterated that view. The drug agency has not moved to change the label, saying manufacturers must request a change. Plan B One-Step’s manufacturer, Teva Pharmaceuticals, declined to comment. It had previously said scientific evidence suggested that the pill did not disrupt implantation.

Although pregnancy is not medically considered to have begun until a fertilized egg has successfully implanted in the lining of the uterus, media coverage around this topic has often obscured this distinction and promoted a false idea that emergency contraception is the same thing as the abortion pill (RU-486) or abortion in general. Medical professionals generally assert that “emergency contraception is not effective after implantation; therefore, it is not an abortifacient.”

Effect on Lawsuits
Hobby Lobby is one for-profit corporation that filed suit to avoid complying with Obamacare coverage for contraception, claiming that forms of contraception that could interfere with the implantation of a fertilized egg are tantamount to abortion. The Supreme Court will hear the case, focusing on whether for-profit companies can be required to provide coverage that may conflict with the private religious beliefs of the business owners.

As Linda Greenhouse wrote in an op-ed about challenges to the contraception mandate under the Affordable Care Act, a coalition of medical groups, led by Physicians for Reproductive Health, filed a brief in the case, noting in part that “the weight of the scientific evidence establishes that the FDA-approved contraceptives and emergency contraceptive are not abortifacients.”

Read Greenhouse’s column for an excellent look at how the religious-based challenges represent a culture war on “modernity.” For more on the lawsuits, SCOTUSblog is a smart resource.

And we highly recommend the Emergency Contraception website for easy-to-understand fact sheets, such as this one: “Does emergency contraception cause an abortion?


November 27, 2013

Worried About the Effectiveness of Emergency Contraception Pills? Here’s An Alternative

Emergency contraception is tremendously important for women seeking to prevent pregnancy after unprotected sex. Activists and public health advocates have worked for years to make EC pills more readily available, and have been successful in getting pills such as Plan B available without a prescription or age restrictions.

Emergency contraception pills containing levonorgestrel (including Plan B) may not be right for every woman and situation, however. Though the pills can be taken up to five days after unprotected intercourse, the pills are most effective (95 percent) when taken within 24 hours and become steadily less effective as more time passes. A different type of EC pill — Ella, containing ulipristal — is thought to keep a pretty high level of effectiveness for the full five days.

News this week has raised another issue of emergency contraception effectiveness: EC pills with levonorgestrel seem to be less effective in women weighing more than 165 pounds, and lose their ability to work in women who weigh more 175 than pounds.

This loss of effect happens regardless of whether women are considered overweight or obese according to BMI charts, or are simply tall — despite headlines that almost exclusively focus on “obese women.”

As Linda Prine of the Reproductive Health Access Project said in an interview with NPR: “This is barely overweight. We’re talking about a BMI over 25. So this is probably more than half of American women. This medication would not work for them.”

The Food and Drug administration is reviewing whether makers of levonorgestrel-containing pills (Plan B, Plan B One-Step, Next Choice, My Way) should be required to revise their labels to include a weight warning. In Europe, the label for one identical product (Norlevo) has already been changed to warn about the loss of effectiveness.

The European label change is what prompted news coverage this week, though the study that informed the change was actually published in 2011.

For that study, researchers reviewed results from two prior randomized controlled trials to look for factors that could explain rates of emergency contraception failure. Not only did they find that overweight and obese women had much higher risks of pregnancy than “normal” weight women (anywhere from double the risk to more than four times greater), but women with a “normal weight” BMI women who are tall also have greater risks of pregnancy.

The authors note that additional research is needed to determine whether these women could be given higher doses of the drug for improved efficacy.

The researchers also found that while Ella (ulipristal) worked at higher weights than levonorgestrel-containing pills, it, too, lost some effectiveness with increasing weight. At about 194 pounds, ulipristal appeared to lose all effectiveness.

Women in need of emergency contraception do have another option, however: the copper IUD (Paragard).

IUDs are intrauterine devices that not only are considered 99.9 percent effective for emergency contraception, but they can remain in place for up to 10 years and are one of the most effective forms of contraception overall. While in the past doctors may have been reluctant to provide IUDs for younger women and women who have not had children, more current research suggests that their concerns about side effects were largely unfounded.

Copper IUDs work to prevent pregnancy by inhibiting fertilization, primarily by preventing sperm from reaching an egg. They may also help to prevent implantation of a fertilized egg, but they do not interfere with an established pregnancy. (It is important to remember that IUDs do not protect against HIV or other sexually transmitted infections, so barrier methods may be needed as well for protection.)

For more information, read more about the safety of prescribing the IUD for teenagers, along with this post on the pros and cons of IUDs. You can also read an excerpt from “Our Bodies, Ourselves” on emergency contraception, and visit the excellent Princeton/ARHP emergency contraception website for more on EC and body size.


November 4, 2013

The Ultimate Guide to the Legal Battle Over OTC Access to Emergency Contraception

In the October issue of the journal Contraception, authors from Harvard Law School and Brown University’s medical school trace the legal and political battles over non-prescription access to emergency contraception.

The authors date the legal dispute back to Jan. 21, 2005, when a coalition of organizations in favor of emergency contraception filed a lawsuit accusing the FDA of ignoring the science and safety and applying different standards to Plan B, a type of EC under review at that time, than the FDA applied to other drugs.

Of course, concern about access and the FDA’s process actually goes back further. Organizations had filed a Citizen Petition four years earlier asking the FDA to approve over-the-counter access. The FDA’s failure to respond to that petition, and rejection of the drug company’s application for OTC status, are what ultimately led to the 2005 lawsuit.

The article in Contraception covers the legal battles and notes the various ways the U.S. government interfered in the FDA’s decision-making. You might recall that politically motivated delays under the Bush administration led Susan Wood, a former assistant FDA commissioner for women’s health and director of the Office of Women’s Health, to resign in 2005.

“I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled,” she said at the time of her decision.

After President Obama took office, and amid hopes that sound policy would prevail over politics, HHS Secretary Kathleen Sebelius overruled the agency’s 2011 decision that Plan B could be made available without a prescription or age restrictions. Noting this and subsequent political interference, the authors comment:

The final resolution of this controversy offers an ideal vantage point to examine the vulnerability of the FDA to political influence. While the FDA has “consistently been named or identified as one of the most popular and well-respected agencies in government”, the ability of the FDA to resist political influence is more precarious than its apparent reputation might suggest. After all, the FDA is not an independent agency. Indeed, the FDA Commissioner serves at the pleasure of the President. What is more, the idealized notion that the science-driven decision-making process of the FDA is insulated from and resistant to the political discourse is incommensurate with precedent.

Yes, that’s lawyer speak, but what it translates to is this: The Plan B drama has shown us that the FDA cannot be relied upon to make purely evidence-based decisions. At any time, a presidential appointee (like Sebelius) might step in to overrule evidence-based decisions. And as we’ve seen with Plan B, the resulting legal battle and limited access to a needed drug can stretch on for years.

Without a doubt, as the authors note, “there can be little questioning the foot dragging and active role played by two successive presidential administrations in shaping the emergency contraception debate.”

Plus: For more on the history of the fight for OTC emergency contraception, view a timeline from the Center for Reproductive Rights, and the original Citizen’s Petition, and check out coverage at Our Bodies, Our Blog. Important posts for context include this item on  Sebelius overriding the FDA’s decision, Susan Wood’s response at the time, and more history of the battle for increased access to EC.


September 16, 2013

Headlines about the “Pullout Generation” Are Premature: Studies Show Multiple Methods of Contraception Use

A recent article in the journal Obstetrics & Gynecology has led to some catchy headlines calling today’s young, straight women “the pullout generation.”

The researchers looked at data from the 2006-2008 National Survey of Family Growth for 2,220 sexually active female respondents ages 15–24 years and found that almost 1 in 3 of those surveyed reported using withdrawal as a method of contraception during at least one month of the study. (It’s not clear how girls who were not having sex with male partners were included or excluded.)

What the study-inspired headlines don’t explain, though, is that very few of these respondents relied only the “pullout” method to prevent pregnancy – maybe even fewer than in older studies.

So it is really accurate to call today’s young women the “Pullout Generation?” Almost 9 out of 10 withdrawal users also used other methods, either simultaneously or at some other point in the study. And let’s not forget that 69 percent of those surveyed always used other methods, such as condoms and the pill.

Those who used withdrawal at any point were more likely to have unintended pregnancies, and more likely to use emergency contraception. While some coverage of the study has noted that those exclusively using withdrawal were “less likely” to get pregnant than women exclusively using other methods, the small mathematical difference isn’t considered meaningful.

When the CDC reported in 2009 on the sexual and reproductive health of young people ages 10-24 (covering the years 2002-2007), about 13 percent of unmarried, sexually active girls and women said they had used withdrawal the last time they had sex. This included those who had used withdrawal alongside another method. Thus, the reporting should have noted fewer than 13 percent were using *only* withdrawal.

In another report of contraception use by adolescents released in 2010, almost 11 percent of sexually active girls in 9th-12th grades reported using only the withdrawal method the last time they had sex. This study uses some data sources that overlap with the CDC’s report.

It’s not clear, then, that increasing use of withdrawal as a main method of contraception is actually “a thing.”

As Ann Friedman suggests in her column on the “Pullout Generation,” that doesn’t mean there isn’t legitimate interest in better and alternate birth control methods. In fact, Global Female Condom Day is today, which makes it the perfect opportunity to learn more about this woman-oriented, non-hormonal method.

For more information on withdrawal, including failure rates and things to think about, see Scarleteen and Bedsider. For more info on female condoms, read this excerpt from “Our Bodies, Ourselves” or our many blog posts on the topic.


September 11, 2013

New Book on Birth Control Overlooks Evidence

The new book “Sweetening the Pill: or How We Got Hooked on Hormonal Birth Control” by Holly Grigg-Spall has generated a lot of discussion and critical response — with good reason.

Grigg-Spall argues that the birth control pill is actually making us sick, and feminists don’t want you to know this.

As a feminist women’s health organization that puts a premium on evidence-based information, we disagree.

As noted in the most recent edition of “Our Bodies, Ourselves,” modern oral contraceptives, which are among the most intensely researched pills in history, are safe for most users. That’s not to say the pill is for everyone — as with any medication, some people’s bodies don’t react well — but in general the pill is an excellent option for many women.

Women who use oral contraceptives are at increased risk of having a blood clot; however, the overall risk is still very low (about six women in 10,000 over the course of a year). In fact, the risk is much higher for women who are pregnant or who have recently had a baby. In addition, the pill carries a number of long-term health benefits, including lowering the risk of ovarian and endometrial cancers.

Our Bodies Ourselves has consistently monitored the safety aspects of the pill and has been critical when the evidence has called for it. OBOS has, for example, helped to spread awareness about the safety concerns of newer drospirenone-containing contraceptive pills like Yasmin and Yaz, and has questioned the FDA’s review of these drugs, which carry higher risks for blood clots (about 10 women in 10,000 taking contraceptives with drospirenone over the course of a year) than older versions of the pill.

The National Women’s Health Network, which advocates for the FDA to take drospirenone pills off the market, has likewise has been a longtime advocate for cautious approaches to contraceptives. (Its co-founder, Barbara Seaman, literally wrote the book on safety concerns about early — 1960s — higher dose versions of the pill.) OBOS and NWHN share a common value as organizations in favor of evidence-based approaches to the risks of any drugs targeted to women.

Fortunately, numerous reviewers are calling out the problems with “Sweetening the Pill.” Lauren O’Neal writes that Grigg-Spall overlooks real benefits of the pill, while Jill Filipovic raises concerns about “scaring women away from highly effective forms of birth control with inaccurate claims.”

Grigg-Spall’s essentialist argument is also under fire. Over at Slate, Lyndsay Beyerstein asserts that “Sweetening the Pill” “offers an insultingly reductive account of what it means to be female:

“If we shut down the essential biological center of femaleness, the primary sexual characteristics, then can we say that women on the pill are still ‘female’?” Grigg-Spall muses, casting ovulation as the sine qua non of femaleness. If so, postmenopausal women, pregnant women, girls, ovarian cancer survivors, and transwomen aren’t really female.

It’s easy to write off Grigg-Spall’s inaccurate and reductionist account, but it’s worth noting that this perspective threatens to distract from the discussion that needs to be happening: Instead of promoting fear, women should be offered more evidence-based information on the benefits and side effects of all contraceptive methods, along with more comprehensive sex education and improved access to their method of choice.

To learn more about the pill, check out:

To learn more about safety issues related to pills containing drospirenone, see these previous posts:


August 30, 2013

Want to Reduce Unintended Pregnancies? Provide Health Education & Support

Almost half of all pregnancies in the United States are unintended. These pregnancies can result in worse health outcomes for both women and their babies, due to potentially poor health prior to pregnancy and delays in obtaining prenatal care and making changes such as quitting smoking.

For a new, small study published in the Journal of Midwifery & Women’s Health, researchers spoke to women in three Michigan neighborhoods characterized as low-income, urban, culturally/ethnically diverse, and medically underserved — basically the type of neighborhood where unintended pregnancy rates are higher than average.

The researchers conducted six focus groups with a total of 41 women, ages 18 to 44 years, who were either pregnant or had been pregnant within the last three years. They sought the women’s input on three important questions:

  1. What could be done to encourage women to recognize their pregnancies early (within six weeks from their last menstrual period)?
  2. What should be the primary action to help women recognize their pregnancy early?
  3. What are the most important things that could help women to be sure of their pregnancies early?

The women identified a few main themes and provided numerous suggestions for addressing these issues, including:

  • Promoting knowledge of reproductive changes in the body: Teach women about their female reproductive system and its cyclic changes, such as timing of ovulation, number of days in a cycle, and how to keep a menstrual calendar.
  • Promoting early testing or confirmation of pregnancy: Assist women to know symptoms of pregnancy and to recognize their pregnancies early through the use of home pregnancy test kits or going to the doctor or clinic to confirm a pregnancy.
  • Providing informational support: Provide a list of locally available pregnancy-related resources, such as clinics, prenatal classes, and educational sessions on women’s health.
  • Providing emotional support: Have a friend to talk with or have nurses, midwives, and other health professionals to go to for guidance during the preconception and prenatal periods.

While small, this type of study — and the prison health study we wrote about earlier in the week — are very much needed, because they ask the people most affected about their needs and experiences.

In this instance, community health workers (residents from each neighborhood employed to promote health and access to health care) were already familiar figures in these neighborhoods, and a participatory research model was employed that was sensitive to the residents’ needs. For example, the researchers provided transportation *and* childcare so the women could participate.

In their “implications for practice” section, the study’s authors urge future research along the themes the women identified. Teaching women about the menstrual cycle, along with the signs and symptoms of ovulation and pregnancy, can help women to take more control over their health and their lives.

As one woman in the study said, “I guess just being taught more in an individual sense of how to recognize things in your own body instead of being lumped, that it would be the standard, like I said earlier, 28-32 days. I mean, if women could really have that sense of, like, knowing how they are, it’s much easier to plan around that, or at least to be aware.”

The researchers also urge systemic approaches to reducing unintended pregnancy and the associated health effects, including comprehensive reproductive education (starting even before adolescence), policies that promote access to pregnancy-related resources and facilities, and access to early pregnancy testing.


July 24, 2013

Single-Size Diaphragm Now on the Market in Europe

SILCS diaphragm

Diaphragms are one of the least popular forms of contraception used by women, according to CDC data, but a new type of diaphragm aims to increase its appeal.

Diaphragms are a barrier method of contraception that block sperm from entering the cervix. They are typically used with added spermicide for extra protection against pregnancy.

Compared to hormonal contraception, the diaphragm has a higher failure rate – 6 percent of women who use it every time they have sex, with added spermicide, may experience an unintended pregnancy within one year, compared to less than 1 percent of women using the patch, pill or IUD correctly; the failure rate increases to 12 percent with incorrect or intermittent use, while the pill failure rate increases to 9 percent.

Some women prefer using a diaphragm because their bodies don’t tolerate hormonal contraception, or because they want a birth control option that can be used only when needed. Diaphragms can also be used as a back-up to condoms; they do not prevent sexually transmitted infections (STIs) on their own.

One drawback to diaphragms is the need to be “sized” by a healthcare provider for the right fit, and sometimes resizing is needed after giving birth or gaining or losing weight. Some diaphragms are made of latex, posing a problem for those with latex allergies or sensitivities.

A new diaphragm recently approved for use in Europe addresses these problems. The SILCS Diaphragm is designed to be one-size-fits-most, and it does not require resizing. It’s also made of silicone, which is expected to be more durable than latex and is less likely to cause skin reactions.

The SILCS diaphragm is the product of a collaboration between between PATH (a Seattle-based global health nonprofit), CONRAD (a reproductive health product development organization operated through Eastern Virginia Medical School), the U.S. Agency for International Development (USAID), and other partners.

PATH describes a user-centered design process for the new device, pictured above:

Over ten years, PATH and its partners led a user-centered design process involving input from women, their partners, and health care providers from five countries. This feedback ensured that comfort, ease of handling, and acceptability were built into the device from the beginning.

The diaphragm will initially be available in six European countries, marketed as the Caya contoured diaphragm. It is expected that the SILCS group will seek approval for marketing in the United States, as well as in low-resource settings around the globe. The ability to provide a diaphragm without sizing by a healthcare provider is expected to make this form of contraception more readily accessible to women worldwide.

This Bedsider feature also take a look at the SILCS diaphragm.


July 10, 2013

CIR Prison Investigation Opens Another Chapter on Sterilization of Women in U.S.

We learned this week of an appalling story involving coerced sterilization of women — an issue that never seems to disappear completely from view despite a long and painful history.

The Center for Investigative Reporting found that at least 148 female inmates in two California prisons were sterilized between 2006 to 2010 — and there may be 100 more incidents dating back to the late 1990s.

Due to supposedly strict limits on sterilization of inmates, state approval was supposed to be obtained prior to these procedures. CIR reports that not only were approvals not obtained, but former inmates report being coerced into agreeing to sterilization.

CIR reporter Corey G. Johnson writes:

The women were signed up for the surgery while they were pregnant and housed at either the California Institution for Women in Corona or Valley State Prison for Women in Chowchilla, which is now a men’s prison.

Former inmates and prisoner advocates maintain that prison medical staff coerced the women, targeting those deemed likely to return to prison in the future.

Crystal Nguyen, a former Valley State Prison inmate who worked in the prison’s infirmary during 2007, said she often overheard medical staff asking inmates who had served multiple prison terms to agree to be sterilized.

“I was like, ‘Oh my God, that’s not right,’ ” Nguyen, 28, said. “Do they think they’re animals, and they don’t want them to breed anymore?”

Pressure was applied particularly to women with multiple children, and doctors apparently tried to bypass the required approval process. CIR reports that when Daun Martin, the Valley State Prison medical manager between 2005 and 2008, became aware of the restrictions, she and the prison’s OB-GYN, Dr. James Heinrich, worked around them:

“I’m sure that on a couple of occasions, (Heinrich) brought an issue to me saying, ‘Mary Smith is having a medical emergency’ kind of thing, ‘and we ought to have a tubal ligation. She’s got six kids. Can we do it?’” Martin said. “And I said, “Well, if you document it as a medical emergency, perhaps.’”

The story prompted The Sacramento Bee to call for a full review into whether “anyone ought to have been disciplined,” and to “make sure all the necessary safeguards are now in place.”

Forced sterilization is unfortunately nothing new in the United States: 33 states at one time allowed it for “eugenic” purposes, often targeting people of color and people with mental illnesses.

The phrase “Mississippi appendectomy” has come to describe much of this abuse, referring to the sterilization of poor black women — especially in the South — who were sterilized without their consent and sometimes without their knowledge.

Back in 2002, Oregon’s governor issued an apology for forced sterilizations carried out on women who were in state care (including, according to one article, “wayward teenage girls”). North Carolina only formally repealed its last forced sterilization law in 2003. The Winston-Salem Journal did a detailed series on these abuses in 2002. West Virginia repealed a law allowing sterilization of those deemed “mentally incompetent” just a few months ago, and it just took effect.

While these states tend to claim that sterilization abuses stopped in the late 1970s, political fighting continues in many states about whether to compensate and how to recognize victims.

Where laws have ended forced sterilization practices, however, it appears that coercion has continued to thrive.

CIR asks that anyone with knowledge of the sterilization abuses in California prisons — whether as a victim, family member, or medical or prison employee — to share their experience via this form or to contact CIR’s Corey G. Johnson directly (916-504-4085, ext. 202 or cjohnson AT cironline.org).


June 28, 2013

Emergency Contraception Can Be Free, But it Takes Planning – And a Prescription

By Michelle Andrews, Kaiser Health News

Women of all ages will soon be able to pick up emergency contraceptive pills at pharmacies and other stores without a prescription or proof of age. What many may not realize, however, is that they can get the pricey pills free under the Affordable Care Act. Doing so, however, may take time and forethought.

“Women may be faced with a tradeoff between timeliness and coverage/cost,” says Adam Sonfield, a senior public policy associate at the Guttmacher Institute, a reproductive health research and policy organization.

When it comes to emergency contraception, timing is important. The pills, which delay or inhibit ovulation, generally need to be taken within three days of unprotected sex or they lose their effectiveness. (One prescription-only pill now available is effective for up to five days after a sexual encounter.)

Like other types of birth control, emergency contraceptives are required to be covered as a preventive benefit without cost sharing in health plans that aren’t grandfathered under the health law or don’t meet certain religious exclusions. But consumers can only receive reimbursement from their insurer for over-the-counter products if they get them through a prescription from a medical provider.

Since it can be difficult to get a prescription immediately, women’s health advocates suggest that women may want to get a prescription ahead of time, perhaps at an annual well-woman visit.

“Then you have it in hand, and you can just go to the pharmacy and fill it when you need it,” says Gretchen Borchelt, senior counsel at the National Women’s Law Center.

This month, the Obama administration announced it will no longer fight a judge’s order to make emergency contraceptives available to women of all ages over the counter without a prescription. Officials, including President Barack Obama, had argued that parents should be involved in their minor daughters’ health care, but the court disagreed. The decision was applauded by women’s health advocates.

There are a number of one- and two-pill brand name and generic emergency contraceptives on the market. The FDA last week approved an application for Plan B One-Step to make the drug available without restrictions over the counter.

Plan B One-Step, a popular emergency contraceptive, isn’t cheap. The product generally costs between $35 and $60, say advocates.

About half of all pregnancies in the United States are unplanned. Use of emergency contraception has increased markedly in recent years. Between 2006 and 2010, 11 percent of women between the ages of 15 and 44 said they had used emergency contraception, according to the Centers for Disease Control and Prevention. In 2002, the figure was 4.2 percent.

Young adult women between 20 and 24 were most likely to report that they had used emergency contraception; 23 percent said they had done so.

The administration’s decision to allow over-the-counter emergency contraceptive sales without age restrictions may have the most profound impact on teenagers. But even though they can least afford a $50 pill, privacy worries may stop young women who are on their parents’ health plans from trying to get reimbursed for it.

“They’d rather not go that extra step,” says Allison Guarino, 19, who finished her freshman year at Boston University this spring and volunteers in a program that teaches pregnancy prevention in Boston high schools. “They’ll just go to the pharmacy and purchase it, keep it a little hush hush.”

That’s not surprising, say experts. The number one reason teenagers give for not using contraception in the first place is that they’re afraid their parents will find out, says Bill Albert, the chief program officer for the National Campaign to Prevent Teen and Unplanned Pregnancy.

Even though these young women can consent to receive contraceptive services on their own, health insurers frequently send insurance “Explanation of Benefits” forms to their parents, the policyholders, describing the medical services covered family members have received.

Cost barriers will continue to be a problem for the forseeable future, but advocates suggest that will change.

Even if Plan B One-Step is the only product on the shelves for a time, “We know it’s part of a longer path to get more of these products available, and that the cost will come down eventually,” says Susannah Baruch, interim president of the Reproductive Health Technologies Project.

Plus: Read about efforts to encourage the FDA to make lower-cost, generic versions of emergency contraception available without age restriction, and view OBOS’s full coverage of emergency contraception.

Provided by Kaiser Health News, an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente. 


June 28, 2013

Ask the FDA to Approve *All* Emergency Contraception Pills for OTC Access

Many readers are already aware of the developments over the past few months regarding prescription-free access to emergency contraception,  including the FDA’s recent approval of Plan B One Step with no age restrictions.

While unrestricted access to Plan B One-Step is great news for women and girls needing timely access to emergency contraception, there are concerns that the cost — between $35 and $60 — puts it out of reach for many users. Unfortunately, the FDA’s approval focused specifically on that one product, and left out generic two-pill versions that would likely cost less.

In his response to the FDA’s plan, U.S. District Judge Edward R. Korman noted that he “did not order the defendants to make the brand-name Plan B One-Step available over-the-counter without age or point-of-sale restrictions,” but instead instructed the FDA “to make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions.”

Korman had allowed, however, that if the FDA believed there was a real difference between the newer one-pill and two-pill products, it could limit its approval to the one-pill form. The FDA did just that, citing the need for additional studies to determine whether women under age 17 could read a two-pill label and correctly take the pills 12 hours apart.

In his initial ruling, Korman said that such data was already available and there is very little risk in varying the 12-hour timing, but added that “if the FDA actually believes there is any significant difference,” it could just approve the one pill version. In his more recent response, Korman called the FDA’s claims “far fetched.”

Our Bodies Ourselves and other women’s health advocates disagree with the FDA’s finding, noting that there is a lack of scientific evidence for the distinction between the one-pill and the two-pill versions.

The National Women’s Health Network has posted a letter, which we encourage you to sign, asking FDA Commissioner Peggy Hamburg to remove  barriers to more affordable, generic EC products. It reads in part:

The FDA’s own scientists concluded that age restrictions were unnecessary for all EC products, and the medical community consensus supports that as well. We urge you to allow the makers of generic EC products to revise their labels to make them available without age or point of sale restrictions.

Leaving lower-cost generics behind the pharmacy counter will disproportionately affect low-income women, racial minorities, and younger women for whom cost is a greater barrier. Withholding more affordable generic options from women could contribute to persistently high unintended pregnancy rates in the United States as compared to other developed countries and to adverse health outcomes among vulnerable populations.

All women deserve access to emergency contraception. Please add your name to the FDA letter today!

Plus: For tips on saving money on the cost of OTC emergency contraception, visit the Emergency Contraception website, a project of the Office of Population Research at Princeton University and by the Association of Reproductive Health Professionals.

And, if you have health insurance coverage, learn more about getting a prescription for emergency contraception, which may reduce the cost to nothing.


June 26, 2013

Who (if Anyone) is Providing Teen Girls Information on Contraception and Safer Sex Practices?

The topic of sex education is often a controversial one, with much attention focused on how much (if any) education teens should receive. Implementation of abstinence-only approaches remains widespread, despite objections from health experts and evidence that comprehensive sex-ed is more effective at reducing teen pregnancy and sexually transmitted infections (STIs).

An article just published in the Journal of Adolescent Health explores the type of sex education teens report receiving, and from whom.

Most of the 2,001 teens ages 15 to 19 who took part in the national study describe themselves as white and living in the suburbs, and most of their mothers have at least some college education. The researchers only looked at teens with heterosexual experiences and make no attempt to address how their responses might differ from those of other teens from different backgrounds.

The findings, however, show some clear gaps in sex education. Among teen girls who were already sexually experienced, only about 2 in 3 had received any information on birth control from a parent (the results were about the same for STI prevention), while about 3 in 4 had received birth control information from a teacher.

Almost all girls (95 percent) reported receiving STI-prevention information from a teacher, but it’s not clear how many of those messages may have reflected abstinence-only education. About 1 in 5 girls had not received any birth control information from either parents or teachers.

Boys fared worse on this measure; more than 1 in 3 boys had never received birth control information from a parent or teacher, unless you count simply being given condoms with no additional information. Boys received STI-prevention information from parents or teachers about as often as girls did, and more of them got info from a healthcare provider when they had no other source, but the rates were still low.

Health care providers do not appear to be filling in the information gap for girls. Among the girls who had not received *any* birth control or safer sex info from parents or teachers, less than 1 in 10 got information from a health care provider. In other words, if girls aren’t getting messages about safer sex and contraception at home or school, they’re not likely to get it at all, even from their doctors and nurses.

The authors encourage improved distribution of sexual health information (SHI) in healthcare settings: “Because the majority of sexually experienced adolescents interface with the healthcare system, healthcare providers are missing many important opportunities to deliver SHI to this population.”

They do not provide any specific guidance for providers, but note that with expanded coverage for preventive and sexual health services under the Affordable Care Act, providers may have more opportunities to see teens and address this issue.


June 11, 2013

Obama Administration Will Stop Trying To Block Some Emergency Contraception Access

Best news all day: ”The Obama administration has decided to stop trying to block over-the-counter availability of the best-known morning-after contraceptive pill for all women and girls.”

The administration is withdrawing its appeal of a ruling that requires emergency contraception pills to be made available without prescription, regardless of age. This is good news for access to the one-pill form of emergency contraception.

In not-so-good news, the administration may still interfere with over-the-counter access to the two-dose form of the drug.

Although the previous ruling required that the two-pill form be made available even before the intended appeal was heard, the Justice Department’s letter indicates that it may still try to require additional data specific to safety of the often more affordable, generic two-dose form in younger adolescents before approving the change.

As SCOTUSblog explains, “the FDA is interpreting Judge Korman’s April order as giving it permission to choose between Plan B One-Step and the two-pill version so that just one of them would be open without restrictions to women of all ages.”

The Center for Reproductive rights, which has been heavily involved in the court cases around this issue, responded:

Now that the appeals court has forced the federal government’s hand, the FDA is finally taking a significant step forward by making Plan B One-Step available over the counter for women of all ages. But the Obama Administration continues to unjustifiably deny the same wide availability for generic, more affordable brands of emergency contraception.

Congratulations and thanks to everyone who has worked for more than a decade to call attention to this important issue. While more work is still needed to make emergency contraception fully accessible to women and girls when they most need it, this recent news puts us much closer to that goal.