A recent ABC news piece and two new journal articles (in The Lancet and Obstetrics and Gynecology) have drawn attention to an emergency contraception drug that is not currently available in the U.S. but apparently has been submitted to the FDA for review.

Emergency contraception pills (EC) currently available in the U.S.  are intended to be taken within 72 hours (3 days) of unprotected intercourse or contraceptive failure.  The drug new drug, ellaOne (ulipristal acetate), can be taken within 120 hours (5 days), providing a longer period in which to prevent pregnancy. [It's worth noting here that women have long been advised that existing EC options can also be taken up to 5 days after intercourse, although that's not the "official" approved recommendation on the drug inserts].

Anti-choice groups such as the American Association of Pro-Life Obstetricians and Gynecologists argue that the pill could cause abortions and be an OTC abortion pill in the U.S., using a definition of “pregnancy” that includes a non-implanted fertilized egg, a definition that is generally not medically or scientifically accepted. These arguments were also presented during debate over the approval of Plan B.

The Lancet study compared ulipristal acetate (30 mg) with levonorgestrel (1.5 mg, the drug in Plan B) among adult women in the US and UK seeking emergency contraception within 120 hours of unprotected intercourse.

The women were followed for pregnancy outcomes, and both drugs significantly reduced the expected pregnancy rate, with the outcomes demonstrating that ulipristal was not inferior to levonorgestrel at preventing pregnancy.

The researchers also looked at rates of pregnancy among those 203 women who received one of the drugs 72-120 hours after unprotected intercourse. They found reduced rates of pregnancy: 0 in the ulipristal group, and 3 pregnancies in the levonorgestrel group, a statistically greater reduction in the ulipristal group (although a couple of changes either way might make a big difference in this result).

The second study, in Obstetrics and Gynecology, also looked at efficacy of ulipristal acetate over various time periods, up to 120 hours, and seemed to demonstrate continuing efficacy beyond 72 hours.

Both studies were funded by the company that owns ulipristal acetate.

A librarian note: searching PubMed for ulipristal acetate only returns a few citations; a search for “CDB 2914″[Substance Name] OR “CDB-2914″ OR “ulipristal acetate” OR “ellaone” is more comprehensive.

A forthcoming article in the journal Contraception, “Pregnancy coercion, intimate partner violence and unintended pregnancy,” looks at whether adolescent and young women have experienced birth control sabotage, pregnancy coercion, and/or physical or sexual violence.

Researchers from UC Davis conducted a survey of 1,278 16-29 year old women seeking care in five California family planning clinics in 2008-2009. The participating women were Hispanic (30%), Black (28%), White (22%), Multiracial (7%) and “Asian/other” (13%). Pregnancy coercion was defined as being told not to use birth control by a partner, threatened with physical harm if they did not agree to get pregnant, being forced or pressured to become pregnant, having hidden birth control because of fear that the partner would become upset, or being told that the partner would have a baby with someone else or leave if they did not become pregnant.

Birth control sabotage was defined as having a partner take off a condom while having sex, put holes in a condom on purpose, take away birth control, or forced sex without a condom.

Participants were also asked about their lifetime histories of physical and sexual violence and history of unintended pregnancy.

The key findings:

• 53.4% reported having experienced partner violence
• 40.9% had experienced at least one unintended pregnancy
• 19.1% had experienced pregnancy coercion
• 15.0% had experienced birth control sabotage

The authors also reported that women who had experienced partner violence in the past were also more likely to have experienced pregnancy coercion or birth control sabotage (35% of those reporting violence compared to 15% of those not reporting violence). Women who had experienced reproductive control (coercion or sabotage) were also more likely to have experienced an unplanned pregnancy. When looking at the data by exposure to partner violence, reproductive control was associated with unintended pregnancy only among those who were exposed to partner violence.

Although the authors looked at lifetime exposures and so could not look at associations within specific relationships or the order of these events in time, one co-author of the study suggested that the associations may “explain why unintended pregnancies are far more common among abused women and teens.”

The researchers conclude that:

Comprehensive screening in clinical settings for the prevalent experiences of pregnancy coercion, birth control sabotage and partner violence should be considered a priority, particularly in the context of family planning and related programmatic efforts to reduce unintended pregnancy. Such screening may facilitate the critical work of addressing barriers to contraception among affected women and girls so as to reduce their elevated risk for unintended pregnancy.

The lead author of the study was also one of the researchers for a smaller study of intimate partner violence and birth control sabotage that we reported on in 2007.

[Note: Although I was able to get a copy of the article, it is not yet readily available online. I'll try to add a link if an abstract/full text becomes available.]

Publicado por Rachel / del orginial en inglés: March 24, 2009

OBOS is committed to expanding our audience and in this spirit we’ve asked former board member Moises Russo to translate into Spanish several of our blog entries. We hope to translate more entries in the coming year.

En OBOS estamos comprometidos a expandir nuestra audiencia de lector@s  y en este espíritu le hemos solicitado a Moisés Russo, ex-miembro de la Junta de OBOS, que traduzca al español varios de los blogs que tenemos en la página electrónica. Esperamos continuar con dichas traducciones durante este año.

Buenas noticias vía The New York Times:

Un juez federal le ha ordenado a la Administración de Alimentos y Comida (FDA) el día lunes que haga la píldora anticonceptiva del día después “Plan B” disponible sin prescripción médica a mujeres jóvenes desde los 17 años de edad.

El juez falló que la agencia había cedido en forma inapropiada a presiones políticas de la administración Bush el 2006 cuando estableció el límite en los 18 años de edad.

La agencia tiene 30 días para cumplir con la orden, en la cual el juez también instó a la agencia a considerar remover todas las restricciones a las ventas de Plan B sin prescripción. El medicamento consiste en dos píldoras que previenen la concepción si son tomadas dentro de las primeras 72 horas luego de una relación sexual.*

Nancy Northup, Presidenta del Centro por los Derechos Reproductivos, el cual demando a la FDA en representación de organizaciones de mujeres e individuos, llamó el fallo del juez “una completa reivindicación del argumento que los defensores de los derechos reproductivos han estado haciendo por muchos años, que en administración Bush era la política, y no la ciencia, la que guiaba las decisiones en temas de salud de las mujeres.

“Plan B” ha estado disponible en los Estados Unidos desde 1999, pero inicialmente solo con prescripción médica. Hubo que esperar hasta el 2006 para que la FDA aprobara las ventas sin prescripción médica a mujeres desde los 18 años de edad, lo cual significa que debe estar en stock detrás del mostrador en las farmacias y que las mujeres deben mostrar un comprobante de su edad. Esto lo hace difícil  para que algunas mujeres, incluyendo a inmigrantes sin documentos, puedan obtener las píldoras en forma fácil cuando las necesitan.

En su fallo de 52 páginas, el Juez Edgard R. Korman de la Corte del Distrito Federal en Nueva Cork concluyó que “no hay ningún propósito útil que esté siendo cautelado si se continúa la privación de acceso a Plan B a mujeres de 17 años sin prescripción médica”, y que “tanto los oficiales como personal de la FDA han estado de acuerdo en que mujeres de 17 años pueden usar “Plan B” en forma segura sin prescripción médica”.

Korman dijo que la decisión de la FDA “no fue el resultado de un proceso de toma de decisiones razonado y de buena fe dentro de la agencia”. El juez citó a oficiales de la FDA por comunicarse en forma impropia con oficiales de la Casa Blanca  sobre “Plan B” y llenar el panel de expertos a cargo de analizar el medicamento con personas que tienen visiones en contra del aborto. La FDA también ignoró las conclusiones sobre seguridad del medicamento a las que llegó de su propio panel asesor.

En un artículo publicado la semana pasada en el Huffington Post, Northrup resume el bizantino trayecto de la aplicación del estatus de venta sin prescripción a “Plan B”, y describe lo que se conoció durante el juicio:

Meses de testimonios en el caso federal han dejado al descubierto una red de engaños tras bambalinas, repleto de oficiales de alto nivel en la FDA doblegándose a influencias políticas externas, eludiendo las regulaciones de la agencia, para finalmente conspirar para otorgar solamente acceso restringido a “Plan B”.

Testimonios judiciales revelaron que un oficial confesó a uno de sus colegas que tuvo que rechazar la solicitud de “Plan B” por miedo a perder su empleo. Otro le dijo a un colega que el plan era que la agencia pospusiera cualquier decisión sobre el medicamento todo el tiempo que fuera posible y, si se vieran forzados a actuar, aprobar el medicamento con una restricción etaria, todo para “apaciguar a los votantes de la administración [Bush]”.

Susan Wood, la anterior directora de la FDA para asuntos de salud de las mujeres, que renunció el 2005 como protesta a las demoras en aprobar “Plan B”, le dijo al Times ahora hay una nueva oportunidad de “restaurar la integridad científica de la FDA”.

Además: ¿Necesitas información sobre Anticoncepción de emergencia, o si tu farmacia más cercana la tiene en stock? Revisa el “Sitio Web de Anticoncepción de Emergencia”, un recurso independiente, con revisión de pares administrado por la Oficina de Investigación sobre Población de la Universidad de Princeton y por la Asociación de Profesionales en Salud Sexual y Reproductiva.

Via AirForceTimes I learned that the Compassionate Care for Servicewomen Act [S 2904/HR 4386], a bill that would require emergency contraception to be made available at all military health care treatment facilities, was introduced in mid-December by sponsors Al Franken (D-MN) in the Senate and Michael Michaud (D-ME) in the House.

NARAL Pro-Choice America praised the bill, noting the bill’s potential affect on women serving overseas, stating, “Sen. Franken’s bill is based on the principle of fairness: Women in the military serving overseas should be able to access EC the same way women stateside do.”

The bill has been referred to the Senate Committee on Armed Services. A similar bill was introduced in 2007 but failed to make it out of committee.

The blogger at Lettuce Spray called the Senate Committee on Armed Services about the legislation (something she also encourages others to do), and learned that “the committee has not yet scheduled anything for January, and are not scheduled to start any hearings until after January 20th. As soon as a hearing date is set (if at all) it will be posted to their website.”

The current issue of the journal Obstetrics & Gynecology includes an article on the risk of bone mineral density loss in users of contraceptive shots (DPMA, or brand name Depo Provera). As we mentioned in a previous post, the drug comes with a box warning that “Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.”

The current study compared women who used DMPA for at least 24 months and had less than 5% vs. at least 5% bone loss to attempt to identify any characteristics that might be associated with a higher risk of bone loss.

The authors report that being a current smoker was associated with higher bone loss, while higher calcium intake (at least 600 mg/day) and having ever delivered a child were associated with lower levels of bone loss. Age, race or ethnicity, previous contraceptive use, and body mass index did not appear to be associated with higher bone mineral density loss.

Although only the abstract of the article is freely available, ScienceDaily provides an additional summary.

In other bone-related news, NPR published a piece this week, “How A Bone Disease Grew To Fit The Prescription,” which describes Merck’s approach to marketing the drug Fosamax, including its efforts to push smaller, cheaper machines to perform bone density scans (and for Medicare payment for the scans) and to expand the “osteopenia” diagnosis.

However, as the piece notes, “There are no long-term studies that look at what happens to women with osteopenia who start Fosamax in their 50s and continue treatment long-term in the hopes of preventing old-age fractures. And none are planned.”

The story and accompanying transcript provide a fascinating look at the marketing of a drug, from the perspective of a former Merck rep who believed he was helping save women from fractures through his marketing efforts, to criticisms of that work as “a plot to misdiagnose American women,” and the debate over whether women with slightly decreased bone density should be medicated at all.

ABC News has an interesting article up on the withdrawal symptoms some women are reporting after stopping Depo-Provera (medroxyprogesterone acetate), an quarterly injectable progesterone-only contraceptive method.

An internet search on Depo withdrawal turns up multiple online postings, suggesting that some women are concerned about or report experiencing a number of symptoms, including nausea, breast tenderness and fatigue.

As the piece indicates, there is not currently a lot of understanding of these withdrawal symptoms; a quick search of the medical literature doesn’t turn up much on the topic. One woman in the article reported that her physicians “shrugged their shoulders” in response to her complaints, and there is uncertainty as to whether cessation of the drug itself causes the symptoms in some women, or if perhaps the drug had been masking some symptoms that return once the injections are stopped.

A physician interviewed for the article used one of my least favorite analogies – comparing women’s bodies to a car to be worked on. Dr. Louis Weinstein, head of obstetrics and gynecology at Philadelphia’s Thomas Jefferson University Hospital, said: “It’s like you don’t know why your car won’t start. Most of [the symptoms] have nothing to do with Depo-Provera. There may be a lot of other things going and to blame that on Depo-Provera is just not fair. We don’t know.”

While existing labeling for the drug does not address potential withdrawal symptoms, it does include (in addition to other side effects) a boxed warning on potential adverse effects on bone mineral density:

Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Depo-Provera Contraceptive Injection during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life. Depo-Provera Contraceptive Injection should be used as a long-term birth control method (e.g. longer than 2 years) only if other birth control methods are inadequate.

Have you taken Depo and then stopped? If you have, please let us know your experience in the comments.

Serra Sippel, CHANGE; Aziza Ahmed, Harvard School of Public Health; Grace Sedio, Bomme Isago Association (Botswana); Sergia Galván, Colectiva Mujer y Salud (Dominican Republic); Massachusetts Representative Kay Khan; Dr. Fisseha Mekonnen, Family Guidance Association of Ethiopia

by Kimberly Whipkey, Center for Health and Gender Equity

“At Colectiva Mujer y Salud, we view each woman as a complete person. If a woman comes seeking an HIV test, we will make sure she also receives information about contraception, screening for gender-based violence, education about her sexual health and a better understanding of her rights.”
– Sergia Galván, Executive Director, Colectiva Mujer y Salud, Dominican Republic

Reproductive health care that is comprehensive, accessible and woman-centered is far from a common reality — anywhere in the world. Global women’s health advocates are campaigning for a more holistic approach that better serves women and their families.

In mid-October, the Center for Health and Gender Equity (CHANGE) invited reproductive health experts from the Dominican Republic, Ethiopia and Botswana to participate in CHANGE’s Reproductive Justice Ambassadors Tour. The tour made stops in Boston, Philadelphia and Washington, D.C., to meet with NGO leaders, activists and key decision-makers.

At each venue, experts discussed why investing in comprehensive sexual and reproductive health and rights is critical at this moment, and they offered suggestions on how the United States can strengthen human rights-based care overseas that breaks down the divisions among HIV/AIDS, reproductive health, and maternal and child health.

The three health experts — Dr. Fisseha Mekonnen Alemu, Grace Sedio and Sergia Galván — offered hope that it is possible to provide comprehensive and rights-based care, even in the face of poverty, a weak health infrastructure and social, political and legal environments hostile to reproductive rights. The obstacles, however, are formidable.

Dr. Mekonnen, executive director of the Family Guidance Association of Ethiopia, discussed his country’s dire maternal health statistics. Only 6 percent of pregnant women have a skilled attendant at delivery, and an estimated 100,000 Ethiopian women suffer obstetric fistula — an entirely preventable condition. Rural women have little or no access to modern health care. And 30 percent of women who die as a result of pregnancy or childbirth do so as a result of unsafe abortion.

Women living with HIV in many countries face layers of stigma and discrimination. Grace Sedio, project officer at Bomme Isago Association in Botswana and member of the International Community of Women Living with HIV/AIDS, spoke about HIV-positive women — especially those who are pregnant— being blamed by public officials in Botswana for spreading the virus. They are often treated as vectors of disease rather than as women with reproductive health needs and rights.

While Sergia Galván, executive director of Colectiva Mujer y Salud in the Dominican Republic, provides comprehensive care through her feminist health center, serious challenges to attaining critical reproductive health services remain. Legislators recently ratified an article within Constitutional reform that prevents liberalization of abortion laws, which currently prohibit abortion under any circumstance. The Constitutional changes were largely influenced by ideological opposition to abortion from conservative factions, including the Catholic Church.

“One Cardinal said he would rather see two deaths [the woman and the embryo or fetus] than one abortion,” Galván said at a Congressional briefing in Washington, D.C.

For eight years under President Bush, the global gag rule stifled NGO advocacy around safe and legal abortion, creating a vacuum in the Dominican Republic that helped enable the Constitutional reform. So, whether a woman is raped, a victim of incest, or suffering life-threatening complications of an ectopic pregnancy, she cannot legally access abortion care, and the situation is unlikely to change anytime soon.

The Ambassadors often highlighted how decisions made in the United States have had major impacts in their countries. They also offered suggestions for how people in the United States can promote reproductive justice globally. For example, Congress is in the early stages of re-writing the Foreign Assistance Act of 1961, which governs how foreign assistance is spent.

One immediate action step is to contact your members of Congress and urge them to support the inclusion of comprehensive reproductive health. For more information, we encourage you to read CHANGE’s new report: “Investing in Reproductive Justice for All: Toward a U.S. Foreign Policy on Comprehensive Sexual and Reproductive Health and Rights.”

At an NGO breakfast meeting in Philadelphia with the Ambassadors, a participant said, “At our health center in Philadelphia we view every woman as an opportunity.”

So, too, should U.S.-funded domestic and international programs see each woman as an opportunity to provide comprehensive and rights-based health services — and an opportunity to improve the health of women worldwide.

Kimberly Whipkey is a senior associate for advocacy and outreach at the Center for Health and Gender Equity in Washington, D.C.

Almost six months after receiving FDA approval as an HIV-prevention method, the FC2 female condom is now available in the United States.

The formal announcement was made in Atlanta last week at the Southeastern Urban Initiative for Reproductive Health Summit, a coalition of reproductive health advocates. The summit was hosted by SisterSong Women of Color Reproductive Health Collective.

The FC2 female condom is a second generation product developed by the Chicago-based Female Health Company. Currently available only to state health agencies and nonprofit organizations, the FC2 will be sold in CVS stores in the Washington, D.C. area starting in December, FHC’s senior strategic adviser Mary Ann Leeper told Reuters.

Washington, D.C. health officials released a report in March showing that at least 3 percent of District residents have HIV or AIDS — a rate that is on par with Uganda and some parts of Kenya.

Female Health Company is looking for a marketing partner to help promote FC2 directly to consumers.

“We need the other company to really make a dent into the consumer market,” said Leeper.

According to the Centers for Disease Control and Prevention (CDC), over the past two decades, the percentage of women among all people living with HIV in the United States has increased from 8 percent to 27 percent. African American women account for 66 percent of new AIDS cases among American women; they are 21 times more likely to contract HIV than white women, while Latino women are five times more likely.

“America’s HIV epidemic isn’t going away. In fact, it’s getting worse, and African American and Latino women are disproportionately impacted,” said Dazon Dixon Diallo, founder and president of SisterLove, a grassroots service organization that supports HIV/AIDS prevention and reproductive health programs for women in the Atlanta area. “It’s time to provide women in heavily impacted communities with expanded access to affordable women-controlled options, and the female condom becomes that choice. Women will use it if they have it.”

Female Health Company says the FC2 is thinner and quieter than its predecessor, the FC1 female condom. The FC2 is made of synthetic nitrile, a latex alternative, so it’s safe to use with both oil and water-based lubricants. Here’s information (pdf) about how to insert the condom. There’s also an animated video demonstration. More resources from FCH are available here.

FC2 may be purchased from the company’s two public sector distributors: Total Access Group, Inc. and Global Protection Corporation.

FHC has also launched a new site, www.fc2femalecondom.com, which includes tiered pricing information for ordering female condoms directly (minimum of 25,000). The maximum price of 82 cents per condom is 30 percent less than the price paid for FC1. A retail price has not been determined.

Though female condoms are not popular in the United States, the FC2 has been available in other countries since 2006. The U.S. Agency for International Development had lobbied for the FDA’s approval — a lengthy and expensive process – so it could be purchased for U.S.-funded global HIV-prevention programs.

Earlier this year, Audacia Ray, program officer for online communications and campaigns at the International Women’s Health Coalition, described other female condom prototypes that are being actively tested and promoted outside of the United States, especially in Africa.

A new report released by the Massachusetts Department of Public Health Family Planning Program and Ibis Reproductive Health examines the barriers low-income Massachusetts women face in accessing contraception services since Massachusetts implemented a universal health care bill.

The bill, enacted in 2006, allows low-income residents who are not eligible for Medicaid or Medicare and don’t have insurance through an employer to join one of four government-subsidized private insurance plans. In addition to these government plan options, low-income women without health insurance can also access contraceptive and reproductive health services at sliding-scale fees through family planning clinics and community health centers.

To document the perspectives of low-income women about these services and identify barriers to services (comparing access before and after reform), the researchers reviewed the four public plans to determine how readily a user could understand them and get needed coverage information, surveyed family planning agency staff and conducted in-depth interviews with family planning and clinic staff, and held focus group discussions with low-income women.

Among their findings:

• There was no central source of information on contraceptive coverage that would allow a woman to compare whether her method would be covered by each of the four government plans. Although each plan provided information on all drugs covered, it was difficult to search and use.
• Providers and women both generally reported easy access to contraception before and after reform, but some women reported experiencing barriers to accessing contraception using a prescription at pharmacies. In some cases, this was because of the pharmacists’ lack of information about the plans’ coverage, and in others there were barriers for the women of time, information, location, and cost. For example, the plans apparently only allow one month of oral contraceptive pills to be filled at a time, creating time/access barriers for some women.
• Women and providers felt that some populations – especially immigrants, young women, those with unstable employment or income, and those experiencing life changes – had been “left out” of the benefits for reform, citing problems of  ineligibility, changing eligibility, and confidentiality.
• In general, women needed more information about contraceptive coverage, how to enroll, and how to document their eligibility for the government plans.

The authors made a series of recommendations, such as better educating providers and pharmacists about coverage under the government plans, developing more user-friendly information about coverage (especially of contraceptives), better supporting family planning clinics, and improving contraception coverage and access (such as allowing receipt of multiple months of hormonal contraception at one time, like 90-day or mail-order options provided by many insurers). Because Massachusetts is currently a unique model for health care reform, these findings may provide points of consideration if a public option is part of the national health care reform.

For more health reform-related discussion, see Christine’s posts on the Healthcare System.

The Dallas Morning News has an article on young people’s access to contraception in that state, which explains that:

Texas, a leader in teen pregnancy and the state where more teens give birth to subsequent children than in any other, maintains one of the most restrictive policies in the nation for minors to obtain prescription birth control. Not even young parents in Texas can get birth control without their own parents’ permission at nearly a third of the family planning clinics on contract with the state health department.”

(emphasis added, hat tip to the National Partnership for Women and Families)

The Des Moines Register has a great recent commentary from Sally Pederson and Joy Corning, former lieutenant governors of Iowa in which they respond to Rush Limbaugh’s apparent statement that “reproductive health care is abortion.” They list numerous other types of needed care for women’s reproductive health, discuss health care reform, and observe that “this kind of outrageous and polarizing language gets the listeners’ attention, but undermines the health care of millions of women and the thousands of health centers that serve them.”

If you tried taking the survey about emergency contraception and found it closed this weekend, it’s because the limit for the basic plan was reached.  The survey site has been upgraded, so please give it another try. Thanks!

And if this is the first you’re hearing of it, read our previous post about the book that Heather Munro Prescott, a history professor at Central Connecticut State University, is writing on the history of emergency contraception and how she could use your input.

Have a few moments to take a survey about emergency contraception?

Heather Munro Prescott, a history professor at Central Connecticut State University, is writing a book on the history of emergency contraception, and she’s looking for input from women who have used EC — as well as input from their partners, health care providers and activists. Prescott is especially interested in hearing from women who used EC in the 1960s, 1970s and 1980s.

Yes, emergency contraception has been around for decades, though most of what we know about EC is connected to the FDA’s recent approval of over-the-counter access to Plan B, a progestin-only pill available to women as young as 17 without a prescription. It reduces a woman’s risk of pregnancy by up to 89 percent when taken within 72 hours of unprotected sex (research indicates Plan B can be taken up to 120 hours after, but the pill is more effective the sooner it’s taken).

Other types of EC are described at the Emergency Contraception website, an independent, peer-reviewed resource operated by the Office of Population Research at Princeton University and the Association of Reproductive Health Professionals. The website also links to Prescott’s survey.

Prescott, who  blogs at Knitting Clio – where you’ll find posts on medical history, disability studies and numerous other topics — outlined her project in an email to Our Bodies Ourselves:

This book will describe the history of emergency contraception from the 1960s until the present and place this story within the larger context of women’s health activism in the second half of the twentieth century. A major focus of the book will be the role women patients played in the dissemination of this technology. This project will show women not only as test subjects for this new method of birth control but also as active health care consumers.

In order to capture women’s experiences with emergency contraception, this project will use data from a survey administered through Survey Monkey: http://www.surveymonkey.com/s.aspx?sm=JNOZJvreEmADWmzx7I1wGg_3d_3d

While I’m covering the entire history of emergency contraception, my replies thus far have mostly been from women and men whose experience with ECP has been very recent. Therefore, I’m especially interested in getting responses from the earlier history of emergency contraception (aka the ”morning-after-pill”) in the 1960s, 1970s and 1980s.

Sounds like a great project, so if you have experience with EC, take the survey, or share the link.

Most users of hormonal birth control have heard warnings that the drugs may increase risk of blood clots. Two new studies in the journal BMJ examine this risk, and attempt to characterize the amount of risk by how long women were on the drugs and the type of hormone. In general, they find the highest risk when women first start taking the pill, decreased risk with decreased dose, and a lower risk with levonorgestrel than with other progestagens.

The first, a case-control study conducted in the Netherlands, compared 1,524 pre-menopausal women who had experienced a deep vein thrombosis or pulmonary embolism with 712 women who had not (the control group). All of the participants completed a questionnaire on risk factors for venous thrombosis such as family history, pregnancy, and oral contraceptive use, and were further interviewed about their oral contraceptive use.

The researchers report a fivefold increase in risk for venous thrombosis associated with oral contraceptive use. The also found different levels of risk by the type of contraceptive in use – compared to women who did not use the drug, those using a contraceptive containing levonorgestrel (the most frequently used in the study) had an almost fourfold increase in risk (odds ratio 3.6). Risk also appeared to increase 5.6-fold for those containing gestodene, 6.3-fold for drospirenone, 6.8-fold for cyproterone acetate, and 7.3-fold for desogestrel. Risk seemed to increase with higher dosages, and to decrease over time – women had the greatest risk as new users in the first 3 months (odds ratio 12.6) which declined to the average 5-fold increased risk after one year.

The second is a cohort study using registry data to track Danish women over time for various types of thromboses and oral contraceptive use. The paper uses “woman years” as a measure of the participants and explains that the study covered 10.4 million woman years of observation (2 years of observation of 5 people, for example, would be 10 person-years). They report that “The overall absolute risk of venous thrombosis per 10,000 woman years in non-users of oral contraceptives was 3.01 and in current users was 6.29.”

These authors also found decreased risk over time, with the highest risk in the first year, a decreased risk with decreased estrogen dose, and a higher risk with contraceptives containing desogestrel, gestodene, or drospirenone were associated with a higher risk of venous thromboembolism than those containing levonorgestrel.

The BMJ issue also includes an editorial on the studies – which notes that while the absolute risk of blood clots is low, providers may need to consider these findings in selecting contraceptives with individual patients – and links to a recent review of different contraception options for women.

Back in April, the Washington Post reported on a Fairfax, Va., high school honor student who received a two-week suspension and was recommended for expulsion for — wait for it — taking her birth control pill.

In the era of zero-tolerance, many schools have rules prohibiting students from possessing over-the-counter and prescription drugs. In Fairfax, the penalties are stiff:

In Virginia, school systems must comply with state code regarding prescription medications and illegal drugs on campus. Students face expulsion if they bring to school any “controlled substance” or addictive drug regulated by the federal government. “Imitation controlled substances,” which could include virtually any prescription pill, are subject to the same hefty repercussions. Local school boards can give a lighter punishment after a review.

A small portion of school health clinics across the country distribute birth-control pills to teens. But in Fairfax, even carrying the pills in a backpack is counted among the most serious offenses in the Student Responsibilities and Rights handbook.

In a 2008 survey, a little more than a quarter of Fairfax teenagers, and 44 percent of 12th-graders, reported being sexually active, according to the Post. And 10 percent of those who said they were sexually active reported not using contraception the last time they had sex.

Deb Hauser of Advocates for Youth, a Washington, D.C.-based organization that focuses on adolescent sexual health, put it best when she said: “To put birth control in the same category as illegal drugs or handguns stigmatizes responsible behavior.”

But leave it to Stephen Colbert to fully contextualize the punishment alongside America’s war on drugs. The student, Freesia Jackson, 17, is a terrific sport in this segment, which aired last week. Fallopian dopers, beware …

If you’re somewhat confused about who can get what forms of emergency contraception and how, you’re not alone. Recent decisions and approvals related to age, dose, and a generic version make the availability details somewhat baffling, but I hope the following will shed some light on the matter.

Earlier this year, a judge ordered that Plan B be made available over-the-counter (OTC) to women 17 and older, rather than the previously set age limit of 18. At that time, the FDA explained that they would not appeal the decision because it was consistent with the scientific findings on the drug, stating that: “…the FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”

However, it wasn’t immediately clear whether the manufacturer had asked for such approval or when it might be issued. The FDA website now indicates a label change meaning that “both Plan B One-Step (see below) and Plan B will be available without a prescription to women 17 years of age and older.”

Last month, a generic version of Plan B (levonorgestrel, to be marketed under the name “Next Choice” according to a company press release) was approved by the FDA, “by prescription only for women ages 17 and under.” While you may assume that the “by prescription only” line is meant to remind us that Plan B has only been available OTC for women 18 and older, that’s not the case. As the FDA’s release notes, “No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.”

Will the generic version be available to women 18 and older on Aug. 24? We don’t quite know yet. It has been suggested that women older than 17 could get the generic version prescribed as an off-label use, but that would of course require a visit to a clinician.

Finally, a 1.5 mg one-pill version of the drug (Plan B One-Step) also has just been approved by the FDA. The older Plan B requires users to take  one 0.75 mg pill within 72 hours after intercourse and a second 0.75 mg pill 12 hours later. The new Plan B One-Step means a woman will only need to take one pill. It will follow the same (but new!) rules as regular Plan B, with OTC access for women 17 and older, and prescription access for younger women.

In summary, and as best I can tell, here’s the availability breakdown right now: