Archive for the ‘Public Policy’ Category

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 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.

June 7, 2013

New Developments in OTC Emergency Contraception Court Case

First, a quick refresher:

A couple of months ago a judge ordered that emergency contraception pills (like Plan B) be made available over the counter (OTC) without age restrictions. The U.S. Justice Department appealed that ruling, and asked for a stay so that OTC access wouldn’t take effect during the appeals process.

Around the same time, the FDA approved Plan B One-Step emergency contraception pills for purchase without a prescription for teens ages 15 and older.

On Wednesday, the Second Circuit Court of Appeals denied the stay for two-pill types of emergency contraception. This means that two-pill regimens should become available without prescription to women and girls of all ages even before the government’s appeal is resolved. The Court allowed the stay for one-pill variants of emergency contraception (e.g. Plan B One Step), and stated that the appeal process would be expedited.

Women’s health advocates have been fighting for more than a decade to make OTC emergency contraception a reality.

Nancy Northup of the Center for Reproductive Rights called Wednesday’s order “a historic day for women’s health,” adding: “Expanding access to this safe and effective way of preventing pregnancy after failed birth control or unprotected sex is the among the very best decisions our federal government can make for women’s health.”

Marcia Greenberger of the National Women’s Law Center remarked, “The Center applauds today’s decision, which underscores the simple fact that there is no reasonable basis for restricting access to this safe and effective birth control.”

The American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and Society for Adolescent Health and Medicine have collectively denounced the administration’s decision to appeal the ruling at all, and issued a strong statement rejecting limited access: “There is no scientific justification for a continued age restriction on emergency contraception. The Administration’s decision puts the health of adolescent girls at risk and is inconsistent with what we know about the safety and benefits of emergency contraception.”

It’s unclear what will happen next in the fight for more accessible emergency contraception. The Justice Department has stated only that they are reviewing the order. According to SCOTUSblog, the administration has the option of asking the Supreme Court to delay all parts of that initial order for OTC access without age restriction. NPR’s Shots explains that “some lawyers say the government might be able to appeal to the full 2nd Circuit. But more likely, if they insist on fighting, government attorneys would have to seek relief from the Supreme Court justice who oversees the 2nd Circuit — Ruth Bader Ginsburg.”

May 31, 2013

Reproductive Justice: The Movement Whose Time Has Come

The Reproductive Justice: Activists, Advocates, Academics in Ann Arbor (“A3 in A2″) conference taking place this week aims to foster learning, dialogue and collaboration around reproductive justice issues. OBOS Executive Director Judy Norsigian, one of the conference advisory board members, is leading a session on informed consent and moderating Friday’s final panel.

Until recently, the term reproductive justice was used mainly by a relatively small number of people involved with abortion rights and women’s reproductive health (read about its history at SisterSong). The phrasing is more inclusive than abortion rights and takes into account all aspects of women’s ability to control their own reproduction, including social inequalities that affect the ability and right to have or not have children and to parent children in healthy environments.

The term has been discussed, and debated, quite a bit lately. Over at RH Reality Check, Jon O’Brien, president of Catholics for Choice, recently argued why reproductive justice cannot be a substitute for the terms “choice” or “pro-choice,” prompting this response from reproductive justice activists (who, it should be noted, consider Catholics for Choice an ally). Their response notes in part:

Women of color struggled within the pro-choice movement to bring their needs to the forefront, and they also created new organizations built on a broad, intersectional analysis and understanding of reproductive rights and health. The shift from choice to justice does not, as O’Brien says, devalue the autonomy of women who face obstacles. Instead, locating women’s autonomy and self-determination in human rights rather than in individual rights and privacy gives a more inclusive and realistic account of both autonomy and what is required to ensure that all women have it. Advocating for reproductive justice was not counter-posed against being “pro-choice” or supporting abortion rights. Rather, reproductive justice re-framed and included both.

The push toward a more comprehensive understanding of reproductive rights has also been adopted by the Unitarian Universalist Association (UUA) of Congregations. Delegates at last year’s General Assembly meeting selected “Reproductive Justice: Expanding Our Social Justice Calling” as the 2012-2016 Congregational Study/Action Issue — meaning congregations and districts are invited to engage and reflect on it, in any way they see fit — and the subject will be the focus of this summer’s GA meeting.

Earlier this year, Billy Moyers invited Jessica González-Rojas, executive director of the National Latina Institute for Reproductive Health, and Lynn Paltrow, founder and executive director of National Advocates for Pregnant Women, to discuss the topic.

“What’s happened is that women are beginning to recognize that what’s at stake is more than abortion,” said Paltrow. “It is their personhood — their ability to be full, equal, constitutional persons in the United States of America.”

For more information: Check out the Reproductive Justice Briefing Book. Produced by the Pro-Choice Public Education Project, it offers a comprehensive look at a variety of topics, including sex education, abortion, adoption, pregnancy, disability, incarceration, immigrants, LGBT issues, race, and class.

May 24, 2013

What Women Need to Know About Health Care Reform and Insurance Coverage

In the Spring issue of Ms. magazine, Cindy Pearson, executive director of the National Women’s Health Network, outlines 10 Things Women Need To Know About Health Reform. Some final provisions of the Affordable Care Act are set to take effect in January 2014; Pearson explains how these affect women’s access to coverage, including protections against higher insurance costs for women.

For example, midwives and birth centers can now be covered by Medicaid, and Pearson provides important details on preventive health services now covered for women:

All insurers now have to cover well-woman exams (thanks to the lobbying efforts of women senators such as Barbara Mikulski), contraception and breastfeeding (even the expensive stuff such as IUDs and breast pumps), cancer screening such as mammograms and Pap smears, domestic-violence screening and STI counseling. If you’re working for Catholic Charities or a religiously affiliated hospital, however, don’t bother asking your HR department about any of this: The Department of Health and Human Services (HHS) has created a work-around so that the bishops don’t have anything to do with your contraceptive coverage.

The print article includes a sidebar (inadvertently left out of the online article) on the not-so-good news: the limitations of the ACA for immigrants and Native Americans, and the political struggles over Medicaid expansion. Check out the full print article for this information and more on enrolling for health coverage, the effects of the ACA on LGBT families, and other issues.

Want more details on health reform and women’s health? Kaiser Family Foundation has published a comprehensive fact sheet on women’s health insurance coverage and an issue brief on Medicaid’s role for women across the lifespan. Plus, you can take this quiz to test your knowledge on women’s health coverage.

The National Latina Institute for Reproductive Health has also produced a fact sheet outlining some of the good and not-so-good aspects of the Act.

Over at the National Partnership for Women and Families, you’ll find 10  Reasons the Affordable Care Act is Good for Moms — a look at how mothers and mothers-to-be, as well as sisters, daughters, grandmothers and aunts, are getting better access to quality, affordable health care — and a state-by-state analysis of how Medicare benefits women.

Below, nurses provide a quick, clear explanation of the Affordable Care Act.

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May 20, 2013

“Educate Congress” Accomplished: Every Member Now Has a Copy of “Our Bodies, Ourselves”

Our Bodies, Ourselves Goes to Washington

Every member of Congress has pages of accurate information on women’s health at their fingertips – more than 900 pages to be exact – now that they have the latest edition of “Our Bodies, Ourselves.”

Thanks to supporters of OBOS’s Educate Congress campaign – inspired by a road trip to deliver “Our Bodies, Ourselves” to then-Rep. Todd Akin – we hand-delivered or mailed the newest edition and a letter signed by prominent health policy experts to all members of the U.S. House and Senate.

Educate Congress launched with a simple premise: Everyone deserves access to accurate information concerning women’s reproductive and sexual health – especially those who write the laws.

Deliveries began Feb. 28, when I spent the day meeting with members on Capitol Hill. It was the day that the House finally passed the Violence Against Women Act, which made the trip particularly poignant.

Joining me were Christy Turlington Burns, founder of Every Mother Counts (EMC), and Erin Thornton, EMC executive director. We collaborated on scheduling and delivered EMC materials along with “Our Bodies, Ourselves,” including a special petition for women members of Congress congratulating them on their leadership role and asking them to affirm support of policies that protect the health and well-being of girls and women around the world, especially those that will reduce infant and maternal mortality rates.

Two National Women’s Health Network (NWHN) interns, Alysson Reddy and Grace Adofoli, provided invaluable logistics support and shoulder-bag transport of the rather hefty copies of “Our Bodies, Ourselves.” We received warm receptions not only from those who know the book and OBOS’s work, but also from members who want to be better prepared to address key reproductive health concerns.

Our first meeting was with Rep. Jim McGovern (MA), a consistent advocate of evidence-based policies. Christy and Erin presented a copy of EMC’s excellent documentary about maternal mortality, “No Woman, No Cry.”

Alysson and Grace helped me walk the corridors of three House office buildings in record time, with stops in the offices of Representatives Adam Kinzinger (IL), Steven Horsford (NV), Gary Peters (MI), Kay Granger (TX), Betty McCollum (MN), Chellie Pingree (ME), Michael Capuano (MA), Marsha Blackburn (TN), James Clyburn (SC), Jackie Speier (CA), Nita Lowey (NY), Anne Kirkpatrick (AZ), Joseph Kennedy (MA), and Cheri Bustos (IL).

The day ended on the Senate side, with visits to Senators Jeanne Shaheen (NH) and Elizabeth Warren (MA). Diana Zuckerman, president of the National Research Center for Women and Families (NRCWF), joined me in discussing women’s health with Sen. Warren and her chief of staff, Mindy Myers.

Time was running short, so Allyson and Grace returned later that week to deliver books and letters to Senators Mitch McConnell (KY), Rob Portman (OH), Carl Levin (MI), Mark Begich (AK) Charles Grassley (IA), Pat Toomey (PA), Jeff Flake (AZ), and Christopher Coons (DE).

OBOS has already received personal thank-you notes from several members of Congress who indicated that the book will be a useful resource. We’re confident it will be of value to staff members working on policy issues.

If you visit the D.C. office of your representative or senator in the coming months, let us know if you get a chance to ask about how “Our Bodies, Ourselves” might have been referenced. Establishing sound, science-based policy about reproductive health is no easy feat, but it will be all the more likely if each of us finds ways to promote this goal.

OBOS will continue to monitor where information interventions are needed. Please help fund our efforts to send books to state legislators, educational leaders, and other public officials.

* * *
Photo, clockwise: EMC’s Erin Thornton and Christy Turlington Burns, Rep. Gary Peters, OBOS’s Judy Norsigian, and NWNH interns Alysson Reddy and Grace Adofoli; Judy and Christy with Sen. Jeanne Shaheen; Judy, Sen. Elizabeth Warren and NRCWF’s Diana Zuckerman; Rep. Chellie Pingree; Judy and Christy with Rep. Jim McGovern (center). 

May 2, 2013

One Step Forward, Two Steps Back: The Week in Over-the-Counter Emergency Contraception

Plan B on a drugstore shelf in Canada.

Plan B on a drugstore shelf in Canada. Photo / Cory Doctorow

What a frustrating week in the ongoing battle over evidence-based health policy.

To the surprise and disappointment of women’s health advocates, the U.S. Justice Department on Wednesday filed an appeal to prevent girls under age 15 from gaining over-the-counter access to emergency contraception.

Approaching the date U.S. District Judge Edward Korman’s order making levonorgestrel-based emergency contraceptive pills (such as Plan B and Next Choice) available without restrictions would go into effect, the Obama administration also requested a stay pending appeal, meaning the judge’s order would not be implemented according to schedule.

The judge’s ruling last month was in response to the Center for Reproductive Rights’ renewed lawsuit seeking over-the-counter access to the morning-after pill.

Responding to the appeal, Nancy Northrup, CRR president and CEO, said in a statement:

Women who urgently need emergency contraception have been delayed in getting it or denied access entirely for more than a decade because of the political maneuverings of the last two presidential administrations. The federal court has made clear that these stalling tactics were based purely on politics, not science.

We are deeply disappointed that just days after President Obama proclaimed his commitment to women’s reproductive rights, his administration has decided once again to deprive women of their right to obtain emergency contraception without unjustified and burdensome restrictions.

In the appeal documents, the administration argues that the court overstepped its authority and improperly interfered with the rulemaking process; the judge should have instead sent the issue back to the FDA for further action.

“We aren’t focused in this appeal on the merits of the secretary’s decision,” a Justice Department official, who spoke on condition of anonymity, told The New York Times. “What we’re focused on is that the remedies that the judge ordered were beyond his authority.”

Ironically, overstepping is what many would argue the administration did in 2011 when HHS Secretary Kathleen Sebelius overturned a decision by FDA scientists to make the contraceptive pills available without restriction.

The administration also argues that since the actual plaintiffs in the case are all over age 15, and it’s not a class action suit, that no harm is done to the plaintiffs by granting the stay (see below). By making this argument, the administration avoids addressing the potential harm to girls who are prevented from accessing a drug both FDA scientists, and the judge, said should be available.

The administration claims that the public would suffer irreparable harm if the stay is not granted; if the ruling is allowed to go forward and later overturned, it would create confusion for women, who might “mistakenly believe that they can obtain the drug without a prescription or at certain locations where it used to be available, but is no longer.”

We’re also supposed to believe the appeal has nothing to do with politics. A Justice Department official told The New York Times: “This is a decision that the Justice Department is making in representing our client: FDA. This is not a political decision. It’s not had White House intervention or involvement. This in our judgment is the right legal step to take in this case.”

Meanwhile, FDA Approves Making Plan B Available to Teens Age 15 and Up
The decision to appeal came just one day after the FDA announced its approval of Plan B One-Step emergency contraception pills without a prescription for teens age 15 and older. The drug was previously only available without a prescription to women 17 and older.

It’s a great step forward; however, younger women, for whom access to a healthcare provider may be most difficult, are still left without prescription-free access to the drug, which must be used within a limited window.

The FDA adds to the burden by specifically requiring proof of age. From the FDA’s press release:

The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.

In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.

The ID/proof of age requirement is a big hurdle for many teens. Many states set an age requirement of 16 for a driver’s license or learner’s permit. Obtaining a state ID (related to driving or not) costs money, and hours for doing so are often limited. And undocumented teenagers are unable to obtain a legal ID at any age.

“While welcomed by some as an acceptable compromise,” said Nancy Stanwood, Physicians for Reproductive Health board chair-elect, the “FDA decision to approve the sale of emergency contraceptive Plan B One-Step to those 15 years and older with government-issued identification does little to improve real access for already-vulnerable women and young teens. Plan B has a time limit, and too many women in the U.S. have gone without it because of unfair, unnecessary, and medically unjustified barriers to access.”

Writing at ThinkProgress, Tara Culp-Ressler explains other reasons why the policy shift is still problematic, noting in part that it simply isn’t based on science, and the high cost remains a barrier.

The FDA’s ruling was in response to an amended application request by Teva Women’s Health, the company that makes Plan B One-Step, to make the drug available without a prescription to women age 15 and older. The FDA in 2011 denied Teva’s application to make Plan B One-Step available for all females of reproductive age. And still the debate goes on.

April 5, 2013

Study: Expand Abortion Access by Expanding the Types of Professionals Who Can Provide Care

In the United States, 87 percent of counties have no abortion provider, forcing some women to travel potentially long distances for reproductive health services, while others delay making a decision until later in the pregnancy, when an abortion is more costly and restrictions are more severe.

One way to increase access is to increase the range of providers who are permitted to do abortions, such as nurse practitioners, nurse midwives, and physician assistants.

Currently, non-physician clinicians can perform surgical (aspiration) abortions legally only in Montana, Oregon, New Hampshire and Vermont. In some states, these providers can oversee medication abortions, though that, too, has become a contentious issue as more legislatures seek to restrict women’s access to abortion.

Are laws requiring physicians to perform surgical abortions necessary, from a patient-safety perspective? Not according to a recently published study.

Tracy Weitz, director of Advancing New Standards in Reproductive Health, a collaborative research group and think tank at University of California, San Francisco, and Diana Taylor, ANSIRH’s director of research and evaluation, primary care initiative, set out to answer the question of healthcare outcomes and applied for a waiver of California legal statutes that limit surgical abortion to physicians. They note:

In 2008, 1.21 million abortions took place in the United States, with more 200,000 (18%) in the State of California. Nationally, 92% of abortions take place in the first trimester, but Black, uninsured, and low-income women have less access to this care. In California, only 87% of women using state Medicaid insurance obtain abortions in the first trimester. Because the average cost of a second-trimester abortion is substantially higher than that of a first-trimester procedure, shifting the population distribution of abortions to earlier gestations would result in safer, less costly care. Increasing the types of health care professionals involved in abortion care is one way to reduce this health care disparity.

For the purpose of the study, 40 certified nurse midwives, nurse practitioners and physician assistants in ANSIRH’s Health Workforce Pilot Project, who already had experience with medication abortions, were trained to perform surgical abortions. (ANSIRH’s Early Abortion Training Workbook, which is used in medical schools around the world, is also available online.)

The authors compared the outcomes of abortions performed by those medical professionals to outcomes of abortions performed by 96 physicians. Patients were not randomized to a provider type; they were asked if they would agree to have the non-MD provider on duty perform their first trimester abortion.

Complications were rare in general, with only 1.3 percent of the 11,487 abortions resulting in any type of complication. While the newly trained CNM/NP/PA group had slightly more complications than the group with abortions performed by more clinically experienced MDs, the difference was not considered significant.

The authors conclude that “only 1 additional complication would occur for every 120 procedures as a consequence of having an NP, CNM, or PA as the abortion provider,” and these would largely be minor complications, such as a low-level infection or bleeding that could be treated at home or at an out-patient clinic.

The study was published in the American Journal of Public Health. Based on the findings, the authors argue in favor of expanding the types of providers who can perform abortions:

The benefits of expanding access to abortion for California’s women outweigh the small initial difference in risk, particularly because it would likely move many second-trimester abortions into the first trimester, significantly decreasing the overall risk of complications, which increases with gestational age. Expanded access is also likely to afford more women the opportunity to obtain care without the additional indirect costs associated with traveling to a geographically distant abortion provider.

We would hope, after reading this study, that more state legislatures would consider removing restrictions on non-physician clinicians, but we know such a move would require great amounts of political will, as the trend in recent years has been to restrict rather than increase access.

March 21, 2013

Are Right-to-Know Breast Density Laws Good for Women’s Health?

There’s been much discussion lately about routine mammogram screening for breast cancer, including, according a new study, the very real psychological harm connected to false positive readings.

Complicating this information further is the issue of breast density. Dense breasts have less fat and more glandular and connective tissue. While some women’s breasts become less dense and more fatty as they age, other women’s breasts remain relatively dense.

Why does this matter? Having dense breast tissue makes it harder to obtain an accurate reading of mammograms. It also increases a woman’s risk of developing breast cancer.

However, questions remain about what women should do with that information. In fact, recent research suggests that actual risk of death from breast cancer is not increased for women with denser breast tissue.

Despite a lack of certainty about how dense breast tissue affects health outcomes, a handful of states have mandated that providers discuss breast density with women. On April 1, California will become the fifth state with a breast density notification law in place. Similar bills have been introduced in other states.

At the federal level, the Breast Density and Mammography Reporting Act was introduced in Congress in 2011, but never made it out of committee. It, too, would require that women be told about breast density, the correlation with cancer, and that they might benefit from supplemental screening tests.

It’s not clear, however, if additional tests would even help.

The authors of a recent commentary in the medical journal Radiology note that while explaining the increased risk of cancer to women with dense breasts “seems ethical, reasonable, and appropriate,” there is little known about what additional follow-up might help those women.

They conclude that “the advocacy push to legislate mandatory reporting of breast density and possible adjunct screening for all women with heterogeneously or extremely dense breasts is far outpacing the reporting of evidence that supplemental screening may provide better outcomes for these patients.”

They also raise concerns about invasive procedures: “Because some cancers detected at screening may not go on to cause symptoms or death, additional interventions performed on these excess cancers would only increase morbidity for these patients.”

These concerns are similar to those raised about routine mammography in younger women — that more testing may increase harm to women from extra procedures, while not actually increasing survival rates.

Breast Cancer Action addressed mandatory notification laws in late 2012, coming down against such legislation:

Unfortunately, the importance of breast density is still not well understood and as a result there is no clear action for women who receive this information. Breast Cancer Action believes that medical practitioners should discuss all aspects of a woman’s health with her and we do not believe legislation is the appropriate way to address the issue of breast density. We believe resources and energy are better spent on working for better medical care and understanding the ways to prevent breast cancer in the first place.

Laura Newman, a medical journalist, has also looked at this issue. Her Patient POV blog has a couple of clear, useful posts, including “Are Dense-Breast, Right-to-Know Laws Helpful?” and “Is the Bar High Enough for Screening Breast Ultrasounds for Dense Breasts?

Where does this leave women, especially those who may be told they have dense breast tissue as a result of one of these new laws? Unfortunately, there is no clear answer right now.

March 11, 2013

FDA Approves Silicone Gel Breast Implant Without Public Meeting

In late February, the FDA approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant for breast augmentation in women age 22 and older and breast reconstruction in women of any age.

It surprises us that the FDA did not hold a public Advisory Committee Meeting prior to approval. All we found was the press release, which notes the FDA based its approval on seven years of data from 941 women, a relatively small number:

Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection. In addition, investigators observed fissures (cracks) in the gel of some Natrelle 410 implants. This is a characteristic called gel fracture and is unique to this implant.

The issue was not reported in a six-year study of the Natrelle silicone gel implant, published in the August 2012  issue of  Aesthetic Surgery Journal.

That study was funded by Allergan (and led by a researcher who is a paid consultant, royalty recipient and stockholder in Allergan). Studies paid for by manufacturers are not uncommon, but it makes it harder to tell what sorts of biases there might be in the results. In this case, researchers noted that between 19 and 43 percent of women required additional surgery — the number varied by whether the implants were for augmentation, revision or reconstruction. The researchers also reported that between 5 and 14 percent of patients experienced an implant rupture.

The FDA also did not post approval documents online, so the seven-year data, which would possibly include newer research results, is not readily available to the public.

The FDA has long known about the temporary nature of silicone gel breast implants. In 2011, the FDA released a report on their safety, urging women to “assume that you will need to have additional surgeries” — a point the FDA reiterated in the press release announcing approval of the Naturelle 401:

“It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren. “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.”

Diana Zuckerman, president of the National Research Center for Women & Families, criticized the approval, questioning why a public meeting wasn’t held and noting that “Allergan has not done a good job of doing post-market studies once their implants have been approved.”

“It seems likely that the FDA decided it was better to hide this information than to make it public at a meeting where implant patients could talk about the health problems that have been caused by these implants,” wrote Zuckerman, who has written frequently about the safety of breast implants.

The FDA is requiring additional “post-approval” studies on several aspects of the Natrelle 410, including study of long-term outcomes in more than 2,000 patients followed over 10 years; rare adverse events in a study to include at least 11,500 women; collection of additional safety and effectiveness data; improvement of the format and content of the patient labeling; and analysis of implants that are removed and returned to the manufacturer.

The additional studies will help determine the risks of these implants. Unfortunately, the results won’t be known for years. In the meantime, women will have implants in their bodies  that have not undergone a rigorous review.

March 5, 2013

Europe Takes on Review of Birth Control Pills Containing Drospirenone

While most birth control pills currently available in the United States are safe for most women, some newer pills that contain the progestin drospirenone have come under scrutiny because of an increased risk of blood clots. Birth control pills containing drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, Yasmin, Yaz and Zarah.

The European Medicines Agency (EMA) announced late last month that it would take another look at so-called third and fourth generation oral contraceptives, including those with drospirenone, and consider whether use of these drugs should be limited.

The agency also plans to review whether current product information is enough to properly inform women and their health care providers of the risks. The agency has also said, though, “There is no reason for any woman to stop taking her contraceptive” — a rather confusing message for women wondering if they should switch to other types of pills.

The EMA previously reviewed whether this type of drug (specifically Yaz) could be marketed for use in preventing acne, but decided it could not based on concerns about the clot risk; it factored in that if women who no longer needed contraception or no longer needed the acne treatment continued on the drug, they would be exposed to unnecessary additional risk.

The U.S. FDA also did a review of pills with drospirenone, and is requiring language about the higher risk of blood clots to be added to the labels. As we noted last year, women’s health experts, including OBOS, have concerns about that review, and about leaving these pills on the market when safer alternatives exist.

That’s a key point in considering pills with drospirenone. While the risk of clots is small, we know the risk is higher with these pills than with other oral contraceptives. As one expert testified before the FDA, “I don’t usually vote against choices, but this time I did. And the reason is because on the benefit side, I didn’t see any improved benefit over the existing available choices.”

In the Women’s Health Activist newsletter in spring of 2012, Amy Allina, program and policy director of the National Women’s Health Network, wrote:

The question for a woman is, what should she weigh these risks against? As some have pointed out, the blood clot risks of pregnancy are greater than those of drospirenone pills. Is that the right basis of comparison? The Network does not believe it is. There are other, safer, ways women can avoid the risks of pregnancy – including contraceptive pills that don’t contain drospirenone. Drospirenone pills don’t provide a unique benefit over other available contraceptive pills. We’re also concerned that most women using drospirenone pills are unaware that other contraceptive pills are safer.

The NWHN has asked the FDA to remove these pills from the market. Allina wrote: “We believe that women who are looking for contraceptive options to help them postpone or prevent pregnancy should not be unnecessarily exposed to a higher risk of blood clots when there are safer alternatives with the same benefits available.”

February 28, 2013

Delivery of “Our Bodies, Ourselves” to Members of Congress Launches on Capitol Hill

Erin Thornton, Judy Norsigian, Rep. Jim McGovern, and Christy Turlington Burns

Last fall, following a sex-ed road trip with The Ladydrawers to deliver “Our Bodies, Ourselves” to former Rep. Todd Akin (of “legitimate rape” fame), Our Bodies Ourselves launched Educate Congress, a campaign to deliver the book to all members of Congress and key administration officials.

The basic premise: Everyone deserves access to accurate information concerning women’s reproductive and sexual health — especially those who write the laws.

Today OBOS kicked off delivery of the book, as Judy Norsigian, OBOS executive director and one of the original authors of “Our Bodies, Ourselves,” hand-delivered copies of the newest edition to about 20 legislators and staff members.

The point was made that the problem isn’t just poorly chosen words; rather, a lot more needs to be done to advance evidence-based health policy.

Norsigian walked the halls of Capitol Hill with Christy Turlington Burns, founder of Every Mother Counts, and EMC’s executive director, Erin Thornton. They submitted EMC’s petition to female members of Congress, asking them to support policies that protect the health and well-being of girls and women around the world, especially those that will reduce infant and maternal mortality rates.

Doing this on the day that the House finally passed the Violence Against Women Act made it particularly poignant.

NWHN interns Allyson Reddy and Grace Adofoli with Judy Norsigian and Rep. Chellie Pingree

Thanks to Allyson Reddy and Grace Adofoli, interns at the National Women’s Health Project, the book launch was a success. More books will be delivered in the coming weeks, until every member of Congress has, in their office, up-to-date information they can rely on when drafting bills that have a real impact on girls and women.

A big thank you to the supporters of Educate Congress! And a special shout out to fellow road-trippers Anne Elizabeth Moore, Rachel N. Swanson, Nicole Boyett and Sara Drake; Congress scheduler Christina Knowles; everyone who participated in the making of the Educate Congress video, especially Paul Noble and Anthony Cupaiuolo (bro!); and Malcolm Woods, who helped organize the Educate Congress launch at the National Press Club and kept the word going on Twitter (with the aid of “The West Wing” staff). All of you made this happen!

Erin Thornton, Christy Turlington Burns (holding the film “No Woman, No Cry”) Rep. Gary Peters, Judy Norsigian, Allyson Reddy, and Grace Adofoli

January 28, 2013

When it Comes to Abortion Rights, the Issue is Access

Although we celebrated the 40th anniversary of Roe last week, access to abortion is not only difficult for many women, but legislators are working to make it even more difficult.

On Saturday, Melissa Harris-Perry opened a discussion on her show with these remarks:

Before 1973′s Roe v. Wade, complications from abortion was the leading cause of death among women of childbearing age. This was especially true for women of color. As access to abortion once again narrows, it puts women’s lives in danger. So while much of the debate about reproductive rights is focused on the legal interpretation and the Constitution and the bodily rights of women, we can’t forget the basic issue of access. [...] Access is the frontier on which we need to be fighting. 

It was a great conversation (watch above if you missed it!), and we were thrilled to see Steph Herold, a New York Abortion Access Fund board member and a contributor to the new edition of “Our Bodies, Ourselves” (which we’re aiming to send to all members of Congress; learn more here), and Feministing editor Chloe Angyal taking part in the round table, along with The Nation editor/publisher Katrina vanden Heuvel and Demos senior fellow Bob Herbert.

Herold talked about the implications of the Hyde Amendment, which since 1976 has banned Medicaid coverage of abortion, and how that limits access for low-income women.

“We really believe that however people feel about abortion, politicians shouldn’t be be able to deny women health care coverage just because they’re poor,” said Herold.

As legislatures reconvene for the new year, we’re keeping an eye on proposed bills that further restrict access to abortion.

In the states:
Proposed bills in Arkansas would prohibit all abortions after 20 weeks, ban the practice of remotely prescribing medication for abortions (otherwise known as telemedicine), and ban abortion coverage in health insurance exchanges.

A bill has been introduced in Florida to ban all abortions except in medical emergencies and to sentence abortion providers (or those who assist or own/run clinics) with up to life to prison. The bill has failed in previous years.

The previously defeated personhood bill is back in Oklahoma.

You may have seen news of a New Mexico bill from Republican state Rep. Cathrynn Brown, which would make it a felony for a woman to have an abortion if the pregnancy resulted from rape or incest. The bill frames such abortions as “evidence tampering.”

Brown claims the bill is being misunderstood; at the very least, it’s poorly written, as it very clearly prohibits not only “compelling or coercing another to obtain an abortion” but also “procuring or facilitating an abortion.” The bill is reportedly being re-written; advocates should keep an eye out for clarification of the language.

Here’s another summary on more abortion restrictions being proposed around the country.

At the federal level:
Multiple bills have been proposed by Tennessee lawmakers to prohibit Planned Parenthood from receiving Title X family planning funding (here’s my personal take as a Tennessean).

A bill has been introduced to define “life” as starting at fertilization.

Other bills would require hospital admitting privileges nationwide for abortion providers (a medically unnecessary move intended to restrict access), and would criminalize people who take a minor across state lines to access abortion, including a sister or aunt as well as other relatives and friends.

January 16, 2013

When Pregnancy is a Crime: Arrests, Forced Interventions in the Name of Public Health

Although this January marks the 40th anniversary of the landmark Supreme Court decision legalizing abortion, we know that there is still much work to be done to ensure reproductive justice for all women.

The Guttmacher Institute reports that 2012 saw the second highest number of abortion restrictions enacted in a single year; the Center for Reproductive Justice addresses each state in this report.

Among the provisions ultimately defeated were “fetal personhood” bills in Mississippi and Oklahoma. But the notion that fetuses should be protected from the women carrying them has resulted in the restriction and punishment of women across America.

Lynn Paltrow, executive director of National Advocates for Pregnant Women, and Jeanne Flavin, a professor of sociology at Fordham University and chair of NAPW’s board, have put together an extremely interesting and important study: “Arrests of and Forced Interventions on Pregnant Women in the United States, 1973–2005: Implications for Women’s Legal Status and Public Health.”

Paltrow and Flavin (who is also the author of the 2008 book “Our Bodies, Our Crimes: The Policing of Women’s Reproduction in America“) tried to identify and examine U.S. cases from 1973, the year of Roe v. Wade, through 2005, in which a medical or government authority tried or succeeded in stripping a woman’s autonomy because of pregnancy. The study appears in the Journal of Health Politics, Policy and Law.

These cases could have involved threat of or actual arrest, incarceration, or increased prison/jail time; detention in a hospital, treatment program, or mental institution; or forced medical intervention. Descriptive detail of several cases is provided, along with summary statistics on the findings.

Looking at legal, medical and other sources, Paltrow and Flavin analyzed 413 cases, which they speculate are “a substantial undercount,” because cases were difficult to identify and some sources referred to additional cases.

The data reveals substantial racial, income and geographic disparities. While almost every state had multiple cases, the regions with the most were the south (56 percent) and midwest (22 percent). These cases disproportionately targeted black women (52 percent of cases overall, and 72 percent of cases in the south), and 71 percent involved low-income women (enough so that they qualified for indigent defense).

Most women who faced criminal charges were charged with felonies; a greater percentage of black women (85 percent) were charged with felonies than white women (71 percent).

The authors explore how these disparities are interlinked with disparities in drug laws, disproportionate application of criminal laws, and outdated stereotypes about cocaine use (such as the “crack baby” myth).

The vast majority of the cases — 84 percent — involved allegations of illegal drug use. In the remaining cases, “women were deprived of their liberty based on claims that they had not obtained prenatal care, had mental illness, or had gestational diabetes, or because they had suffered a pregnancy loss.”

Although concern for the health of the fetus/infant is typically offered as a reason for increased scrutiny or detainment of pregnant women, in 64 percent of the cases there was no reported health issue cited in the allegation.

Chillingly, most cases were reported by people in so-called “helping professions”: health care providers (41 percent), social workers (12 percent), and hospital, child protective services, or police personnel (17 percent). Health care providers reported black women at a higher rate (48 percent) than white women (27 percent).

As the authors point out:

Due in part, no doubt, to the strong public health opposition to such measures, no state legislature has ever passed a law making it a crime for a woman to go to term in spite of a drug problem, nor has any state passed a law that would make women liable for the outcome of their pregnancies. Similarly, no state legislature has amended its criminal laws to make its child abuse laws applicable to pregnant women in relationship to the eggs, embryos, or fetuses that women carry, nurture, and sustain. No state has rewritten its drug delivery or distribution laws to apply to the transfer of drugs through the umbilical cord. To date no state has adopted a personhood measure, and no law exists at the state or federal level that generally exempts pregnant women from the full protection afforded by federal and state constitutions.

In other words, nothing about existing law should make women subject to such persecution. They also note that public health groups have observed that targeting pregnant women may lead to women avoiding medical care or having unwanted abortions to avoid increased and punitive scrutiny.

Paltrow and Flavin also highlight these cases in the context of proposed personhood laws, which would give fetuses individual rights and potentially could lead to increased prosecutions of women. They authors note that they have identified “more than two hundred cases initiated against pregnant women since 2005 that also overwhelmingly rest on the claim of separate rights for fertilized eggs, embryos, and fetuses.”

Opponents to personhood laws have cautioned that such measures could lead to forced medical interventions on pregnant women along with possible punishment for miscarriages and stillbirths. While personhood proponents often dismiss these warnings as scare tactics, the research shows there is good reason to be concerned.

Paltrow and Flavin conclude with a call for change:

In light of these continued efforts and our findings, we challenge health care providers, law enforcement and child welfare officials, social workers, judges, and policy makers to examine the role they play in the arrests and detentions of and forced interventions on pregnant women. We call on these same people to develop and support only those policies that are grounded in empirical evidence, that in practice will actually advance the health, rights, and dignity of pregnant women and their children, and that will not perpetuate or exacerbate America’s long and continuing history of institutionalized racism.

Finally, our study provides compelling reasons for people who value pregnant women, whether they support or oppose abortion, to work together against personhood and related measures so women can be assured that on becoming pregnant they will retain their civil and human rights.

The whole article is well worth a read if you can get a copy. The abstract is freely available online.