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The Power of Pills: Putting Abortion Back in the Hands of Women Around the World

4:02 pm in Uncategorized by RH Reality Check

Written by Leila Hessini and Alyson Hyman for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

A collection of different pills

As governments force clinics out of business, pill-based abortions offer freedom of choice to women.

Unwanted pregnancies are a fact of life. Globally, nearly a fourth of all pregnancies are unplanned and 22 percent of pregnancies end in abortion. Women experience unwanted pregnancies because they have forced sex, (worldwide, one in three women are survivors of sexual violence), they don’t have access to contraceptives, or they simply didn’t plan on becoming pregnant.

Women who have unwanted pregnancies should be respected and their rights to choice upheld. However, in many countries, government policies, and societal practices do not uphold women’s right not to continue a pregnancy and women with unwanted pregnancies are forced into motherhood. Certainly this is evident in the United States; just before the new year, the governor of Virginia quietly signed legislation designed to close abortion clinics in the state. These laws are punitive, restricting women’s reproductive autonomy and freedom and creating categories of who can and can’t obtain abortions.

Fortunately for women, pills have changed the landscape of abortion. Abortion with pills, also known as medical abortion (MA), provides a safe, low-cost and easy to use method to terminate pregnancies. In addition to being safe and effective, medical abortion has changed the dynamics of who can provide abortions, where women get them, and who has control over the process. Evidence shows that those closest to women — community health workers and midwives — and women themselves can be trained to use abortion pills to safely terminate a pregnancy, thus giving women back the control of their own bodies. In fact, it was women in Brazil who first discovered the potential of misoprostol (cytotec) to safely end an unwanted pregnancy and who shared this knowledge through their social networks.

In order for women to benefit from the potential of medical abortion, however, they must be active participants in decisions related to where drugs are distributed and for what cost, what information is shared and by whom, and what social and medical support is needed.

Last month, Ipas hosted a meeting — “In Women’s Hands: Increasing Access to Medical Abortion Drugs and Information through Pharmacies and Drug Sellers” — in Nairobi, Kenya, that brought together 66 participants from 11 countries to discuss these important issues. Participants included a Kenyan hotline program manager, president of the Ugandan Midwives Association, several pharmacy managers from South Africa, and a Nepali senior public health officer in the Ministry of Health and Population, to name a few. The broad swath of countries and professionals represented illustrates commitment to a movement — to give women control of their reproductive lives, particularly through abortion with pills. In different countries, women, advocates and providers have developed innovative strategies to meet this goal.

In Tanzania, the Women’s Promotion Centre founded its own small pharmacy in a rural community as an alternative model for supporting women’s access to safe motherhood and abortion. This effort was born out of the “fire of anger about unnecessary deaths and suffering of women and… passion to save mothers’ lives in Kigoma,” said Martha Jerome of the Centre. Because no pharmacies were selling the lifesaving drug misoprostol, they founded a pharmacy to provide the drug themselves. They trained staff to provide counseling and support and they formed an alliance with like-minded doctors to help women with any complications. They also supply contraceptives as well as other medicines. The competition that resulted from their lower prices has driven down the cost from other private drug sellers, making these medicines more affordable for women who need them.

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Texas Abortion Drug Bill Could Mean More Side Effects and Higher Costs

12:51 pm in Uncategorized by RH Reality Check

Written by Mary Tuma for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

CORRECTED December 20, 2012, 12:41PM ET: This story originally said the mifepristone drug label was last revised in 2005. In fact, minor revisions were made to the label in 2009, but the FDA’s protocol for using the medication wasn’t changed.

Published in partnership with The American Independent.

A GOP lawmaker is looking to make Texas the latest state to restrict the use of abortion medications in a way that some experts warn could increase the drugs’ side effects while making them more expensive.

Anti-choice activists and legislators can’t enact an outright ban on abortion-inducing drugs like mifepristone (formerly known as RU-486). Instead, they have sought to force doctors to strictly adhere to U.S Food and Drug Administration guidelines that appear to be significantly out of step with the current scientific understanding of how the medications should be used.

Lawmakers have passed abortion drug restrictions in Arizona and Ohio, overcoming legal challenges. The Oklahoma Supreme Court recently ruled that similar legislation in that state was unconstitutional. A North Dakota bill is currently tied up in litigation.

In Texas, state Sen. Dan Patrick’s bill, which mirrors model legislation drafted by anti-choice group Americans United for Life, would require doctors who prescribe an abortion drug to follow the protocol outlined in the official drug label approved by the FDA. He introduced similar legislation in 2011 — with the AUL’s support — but it didn’t pass. Patrick also authored the state’s controversial pre-abortion sonogram law.

In most state’s, doctors aren’t required to abide by the FDA guidelines. And since the FDA only regulates the drug market and not the practice of medicine, “off-label” treatment isn’t against federal law either. In fact, the FDA itself notes that physicians may prescribe a medication off-label as long as they are well informed about the product and “base its use on firm scientific rationale and on sound medical evidence.”

AUL insists that off-label use of mifepristone “can be deadly.” While Patrick did not respond to interview requests from The American Independent, he “said the intent of [the bill] is to improve the doctor-patient relationship” in an email to the Texas Tribune. But the legislation’s strict adherence to the FDA guidelines worries reproductive health care advocates and medical experts. They say a substantial body of recent research shows that the mifepristone drug label is outdated, potentially creating unnecessary burdens, financial costs, and health risks for women.

During a medical abortion, mifepristone is given to the woman at the clinic. The second round of medicine, misoprostol, is taken a day or two later to help end the pregnancy.

The FDA guidelines say that women should take 600 milligrams of mifepristone. But 2012 World Health Organization guidelines recommend a lower dose of mifepristone. Citing several studies, the report states that “200 mg of mifepristone is the dosage of choice, since it is as effective as 600 mg, and reduces costs” when it is followed by a dose of misoprostol.

Some of the language in Patrick’s bill is ambiguous, but it appears that it would also require women to receive their second dose of abortion pills — the misoprostol — in the presence of her doctor rather than at home, where it is typically taken. A number of reproductive health advocates find that rule troubling.

According to the National Abortion Federation, the majority of women who take mifepristone will abort within four hours of using misoprostol. Because of this, most women choose to take the misoprostol dose in the comfort of their own home due to painful side effects such as cramping and excessive bleeding that can also occur within the first few hours. Nausea, vomiting, and fever are among the other side effects women may experience, according to NAF.

“Women want to plan for the expelling of this fluid and blood tissue at their own time and they want to be in a comfortable place,” said Elizabeth Nash, state issues manager with the reproductive health and policy-based Guttmacher Institute. “So you can understand why a woman would want to take the medicine at home, especially if she has a fair distance to travel, which could happen in a place like Texas.”

The FDA guidelines and, apparently, Patrick’s bill do not give women the option of taking the second drug at home.

But the medical consensus has evolved in recent years. Unlike the old FDA guidelines, the 2012 WHO guidelines say that “[h]ome use of misoprostol is a safe option for women.”

Similarly, abortion drug guidelines set forth in 2005 by the American Congress of Obstetricians and Gynecologists say that the lower 200-milligram dose of mifepristone is as effective as the higher, FDA-approved dosage and that “multiple large studies in the United States have demonstrated that a patient can safely and effectively self-administer the misoprostol … in her home.” The ACOG guidelines note that the alternate drug regimens were developed in an effort to “reduce side effects” and “make medical abortion less expensive, safer, and more rapid.”

Dr. Mitchell Creinin, who worked on the ACOG guidelines and currently chairs the Department of Obstetrics and Gynecology at the UC-Davis, says the FDA-approved regimen is “outdated” and that the “vast majority” of providers follow the updated protocol.

The FDA guidelines don’t just stipulate when and where the woman can take the abortion drugs, but how. Misoprostol is only approved by the FDA for oral use, says Creinin, whereas research has shown that ingesting a higher dose of the medicine buccally (placing the pill in between your teeth and cheek) or vaginally can, in some instances, decrease side effects and work faster and more effectively — especially as the pregnancy advances.

According to ACOG, the new protocol is effective for women who have been pregnant for up to 63 days; by contrast, the FDA guidelines limit the use of mifepristone to the first 49 days of pregnancy.

The proposed law could also place significant financial and logistical burdens on women. At roughly $100 for each 200-milligram pill, the FDA’s higher mifepristone dosage is expensive. Moreover, Texas already mandates an ultrasound at least 24 hours before an abortion, so the legislation would actually require four separate trips to the doctor (for the ultrasound, the mifepristone, the misoprostol, and a follow-up visit.)

Texas OB-GYN and abortion provider Dr. Bernard Rosenfeld says the FDA guideline requiring women to take the misoprostol in a clinic was meant to standardize a variable in the trial and that several subsequent studies have shown women can safely take it at home.

Rosenfeld, who has practiced medicine for more than three decades, says the rule goes against “good medical practice” and advises all his patients to take the pills at home.

“There is zero medical basis or benefit to take the pills in the clinic,” he said. “To make a woman come back to the doctor’s office and then find a way to get back home after taking the drug is really just mean and cruel and puts them at medical risk.”

“It’s really just meant to give women a hard time,” he added.

The bill also compels doctors to create a contract with another physician who promises to treat the woman should an emergency arise from the drug. The doctor must have “active admitting, gynecological and surgical privileges at the hospital designated to treat the emergency.” But because some women, especially those in rural areas, may have to travel far to receive an abortion, the hospital in which the admitting doctor works may not be the closest to the woman in the event of a medical emergency.

“Living in a small, rural town can be really problematic for a woman seeking an abortion under these rules,” said Nash. “This part is not well thought out. It does not think through what actual steps will be best for the patient.”

The legislation seeks to penalize doctors who do not follow the requirements. According to the bill, the Texas Medical Board may take disciplinary action, such as revoking a medical license, or assess an administrative penalty, which can mean a fine of up to $5,000 if a doctor fails to comply.

‘More dangerous and more expensive’

Anti-choice lawmakers promote the use of outdated FDA rules when it comes to abortion-inducing drugs as a way to stigmatize doctors, says Nash.

“Whenever you invoke the FDA guidelines you are essentially making it wrong to do something that doesn’t abide by them. But in reality, what we are talking about is off-label protocol that is less expensive and has fewer side effects,” she said.

Anti-choice advocates disagree. Dr. Donna Harrison, a pro-life doctor and director of research and public policy at the American Association of Pro-Life Obstetricians and Gynecologists, says the rigorous FDA process should be followed.

“The FDA guidelines are the only real safeguard for the American people,” she said.  ”So when you go off-label with the drug, you are experimenting on women.”

But doctors in many medical fields routinely prescribe off-label drugs. A 2006 study found that an estimated one-in-five drug prescriptions were off-label.

A 2007 study found that 79 percent of pediatric patients discharged from the hospital received off-label drugs. Off-label drugs are also commonly used in cancer treatments. According to a 1997 survey of 200 cancer doctors conducted by the American Cancer Society and the American Enterprise Institute, 60 percent of them prescribed off-label drugs to patients.

“Off-label use is pretty much the mainstay of how we use medicine in the U.S.,” says Creinin, pointing to everything from birth control regimens to anxiety medication. “Just because a drug is approved by the FDA doesn’t mean there aren’t better ways to use it after approval. Research continues on the drug and finding new uses and assigning different dosages is normal.”

“The bill is really about trying to make providers look as though they are not following the rules when in fact, [the more recent protocol] is just as safe and effective and actually has additional benefits,” said Nash.

Creinin is skeptical of legislators’ intentions.

“The question here is: why would lawmakers, who say they are looking out for the health and welfare of their constituents, want to legislate that women must follow the label when sufficient medical literature shows the old guidelines are more dangerous and more expensive?” he said. “What they’re really trying to say is that they know more than the doctor – but they really need to be getting out of this business.”

‘No medical benefit whatsoever’

Dr. Lisa Perriera, a fellow with Physicians for Reproductive Choice and Health in Ohio, is familiar with the legislation. She says that after her state passed its own law in 2004 restricting use of mifepristone, she began to see unfortunate consequences. For example, patients have reported back that after receiving their misoprostol dose in the clinic, they begin to experience uncomfortable side effects while driving home from the clinic.

“We have patients that have to travel as far as five hours in a car while the abortion process starts – that’s just not fair,” said Perriera.

Based on her experience, Perriera says the legislation has not deterred her patients from having abortions; it has simply affected how they have them. As a result of the seven-week gestational limit, more of them have switched to surgical abortions.

“Some women want to have abortions naturally, without medical instruments, but this bill would eliminate that option for them,” she said. “Legislating the way women have to take their medicine is taking choices away from them.”

In the end, the rules have made it “more inconvenient for patients and more costly,” said the Ohio physician.

“It is also forces women to undergo more visits for no medical benefit whatsoever,” said Perriera. “So this is really not about their health and safety.”

Missed Your Period? Don’t Want to be Pregnant? There is an App for That

11:12 am in Uncategorized by RH Reality Check

Written by Karin Gardiner for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

“To avoid judgement and fear, it is always useful step into the shoes of another person. I invite you into mine.”

Colorful window display lists drug prices.

A Mexican pharmacy window

So begins the journey of a 19-year-old Mexican named Claudia, protagonist of an inventive computer game.

¿No Te Baja? which translates as Missed Your Period? makes use of bright colors, engaging cartoon characters and relatable, non-technical, language to inform and guide users through the steps they can take to terminate a pregnancy using Misoprostol. The website takes the form of an interactive, Choose Your Own Adventure style game, where users click through to different scenarios that change according to their own personal situation and decisions.

Misoprostol, a drug used to treat ulcers, is easily available for purchase throughout Mexico, and, unlike in the United States, does not require a prescription. Use of Misoprostol to terminate pregnancy is widespread in parts of Mexico where abortion is illegal, but pharmacy workers often lack the knowledge of how the drug should correctly be administered — and criminalization means that helpful information is scarce.

Although abortion of up to 12 weeks of pregnancy is available on demand in Mexico City, the situation is quite different in the rest of the country. In fact, Mexico City’s 2007 legalization of abortion prompted a backlash from 17 other states, which passed amendments stating that life begins at conception, ushering in a much stricter enforcement of already existing anti-abortion laws.

Users of No Te Baja, through the actions of Claudia and her boyfriend, go through each detailed step of the process of self-administering a medication abortion: from the initial pregnancy test to the decision whether or not to involve the partner; the signs and symptoms of an ectopic pregnancy to calculating gestational age to indicate whether or not use of Misoprostol will be effective — and if it will be safe to self-administer.

The game advises that Misoprostol can be purchased in most pharmacies and that it may be sold under various other commercial names including Cytotec, Cyrox, and Tomispral.  Users receive detailed information on how to administer Misoprostol through the mouth or the vagina, noting that, in the event of having to seek medical attention, medical personnel would likely be able to detect the remnants of the pills inside the vagina — important information for women living in areas where they can be prosecuted for inducing an abortion.

The central Mexican state of Guanajuato, where hospital staff report suspicious miscarriages to the police, is one such place. The Nation described the state’s approach to dealing illegal abortion in a January 2012 article by Mary Cuddehe:

“The state has opened at least 130 investigations into illegal abortions over the past decade, according to research by women’s rights groups, and fourteen people, including three men, have been criminally convicted. Given Mexico’s 2 percent national conviction rate during its most violent period since the revolution, that’s a successful ratio.”

No Te Baja doesn’t end with the final dosage of medication: users (and Claudia) are informed of what signs to look out for that would require medical attention, and of how to tell if the abortion is incomplete. The final stages of the game offer information on how to avoid another unplanned pregnancy with detailed descriptions of different methods of contraception.

Photo by ArizonaGlo released under a Creative Commons No Derivatives license.

The Chilean Safe Abortion Hotline: Assisting Women With Illegal, But Safe, Misoprostol Abortion

1:04 pm in Uncategorized by RH Reality Check

Fuerza Chile!

(Photo: Majo's Photos/flickr)

Written by Emily Anne for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

The phone buzzes insistently and I scramble to answer it. Nervously, the woman on the other end explains that she has six pills of misoprostol, and wants to know how to use them to induce an abortion. I explain that according to the World Health Organization (WHO) the recommended dose is 12 pills spread over nine hours, dissolved under the tongue. I explain the symptoms, and how to recognize problematic bleeding or infection. But I can’t say much more, or ask her any questions about her health, because helping a woman to get an abortion is illegal in Chile, and if we were caught openly discussing it, both of us could be arrested.

After I finish explaining, there’s a long pause. Finally, she asks if there’s a doctor she can call if there’s a problem. This is perhaps the biggest concern for women who have abortions in Chile: a misoprostol abortion is very safe, but if something does go wrong, women may hesitate to seek treatment because they face up to three years in prison if they’re reported to the police. I assure her that as long as a woman puts the pills under her tongue, she’s safe — in an emergency room, a misoprostol abortion looks exactly like a miscarriage.

As part of Chile’s only abortion hotline, most of my conversations with women are like this. I have to follow a lawyer-approved script that keeps us just on the right side of the law. While it’s impersonal, it’s the only way we can actually reach women without putting our callers and ourselves at risk.

Chile is estimated to have one of the highest abortion rates in all of Latin America, but it has one of the strictest anti-abortion laws in the world. Abortions are banned under all circumstances, including saving the woman’s life. Naturally, this has forced women to seek abortions outside of the law — with varying levels of safety.

That’s why the Chilean safe abortion hotline was launched in 2009. It’s run by a national network known as Lesbians and Feminists for the Right to Information. The hotline is open 365 days a year, for four hours a day, on a completely volunteer basis. Women call from all over Chile, and they are offered information on the correct dosage and administration of misoprostol, its contraindications and side effects, as well as information on abortion law and legal rights. Since its launch, it has received more than 10,000 calls, up to 15 a day.

There are five hotlines like ours in Latin America (Chile, Argentina, Ecuador, Peru and Venezuela), and others around the world. Some are independent, and others work closely with organizations such as Women on Waves, which uses tele-medicine  to provide medical abortions to women in countries where it’s illegal.

Of the five Latin American hotlines, Chile’s faces the most constraints. We do have the right to share public information with the women who call us — but that’s about it. That means addressing women in the third person (“According to the WHO, a woman can….”), and not asking any questions. Cell phone minutes are expensive, and sometimes women run out of minutes before we finish explaining the procedure. If the line does go dead, we have no way of knowing if we’ll ever be in touch again. We also can’t provide any kind of counseling, and there’s not much we can do to address the social stigma of abortion. And as far as the pill itself is concerned, women are on their own.

Some women who call are already very informed about misoprostol, and looking for answers to very specific questions. Some are surprising: one woman called to ask if she could eat watermelon during the abortion (answer: yes!). Others have never even heard of misoprostol. Some have the full support of their partner, a family member, or a friend. But others call us in the midst of the abortion, because they are alone and are terrified that something will go wrong.

Some women are confident and matter-of-fact about their decision. Others call in tears, explaining that they can’t have a baby because they are already mothers, or are students, or have no support from their partner. Those are the calls that stick with us, because although we may believe that any reason not to have a baby is a legitimate reason, we can’t remove a lifetime of stigma and guilt in a five-minute phone call.

We can offer the information we do because it’s already available online from organizations such as the WHO, International Consortium for Medical Abortion, Ipas, and Women on Waves. Of course, for most women it’s not obvious where to find it, and there’s no guarantee they’ll understand the medical terms if they do. As an organization we have much more access to these resources. Some of us have been trained in misoprostol use by these international organizations. Some of us are health professionals. Some are involved in extensive activist networks, and have been able to share information and strategies with women around the world. These experiences allow us to take this public information, and present it in a way that’s accessible to as many Chilean women as possible.

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Abortion is Legal: So Why is Self-Abortion Care a Crime?

7:33 am in Uncategorized by RH Reality Check

Photobucket

Written by Susan Yanow and Steph Herold for RH Reality Check. This diary is cross-posted; commenters wishing to engage directly with the author should do so at the original post.

Last week, a 20-year-old woman in New York City was arrested on charges of “self-induced abortion” and faces first-degree misdemeanor charges.  Initial news reports indicate that she intentionally caused the miscarriage/abortion of her 24-week fetus.  The woman disposed of the fetus in what was probably the only way she could think of: wrapped in plastic bags and placed in the trash receptacle of her apartment building.

The prosecution of this woman echoes similar cases in Idaho, Massachusetts and South Carolina.  In spite of ever-increasing restrictions, abortion is legal through the second-trimester throughout the United States, although it is inaccessible to many women.  Yet if women safely end their pregnancies without medical supervision, they face criminal penalties.

The key word here is “safely.” There are many misconceptions about what happens during a non-surgical abortion.  In fact, abortion with medications (such as misoprostol alone or in combination with mifepristone) causes a miscarriage.  The symptoms of abortion with medicines in the first trimester are exactly the same as a miscarriage, and as safe.  Rarely do women who have a miscarriage need medical attention; the same is true for women having a medication abortion.

In the second trimester, the risks of a complication after a miscarriage, whether occurring spontaneously or provoked by medicines, is somewhat higher.  However, it is notable that the woman in New York City, like the women prosecuted in three other states, was in the second trimester and did not require any kind of medical intervention after her abortion.  We have to ask then – is the outcry when women choose to self-induce truly driven by the need to protect the health and safety of the woman?  Or is this another example of over-regulation because of the politics of abortion? Read the rest of this entry →

How the Ohio Court Decision on RU-486 Set Back the Clock on Fifteen Years of Medicine

6:57 am in Uncategorized by RH Reality Check

Written for RHRealityCheck.org by Editor-in-Chief Jodi Jacobson.

In 2004, the Ohio legislature passed a law barring use of RU-486, the combination drug used for early termination of pregnancy, unless it was prescribed strictly in accordance with official labeling by the Food and Drug Administration. The law never went into effect because of an injunction immediately sought and won by Planned Parenthood of Ohio and partner organizations in a suit claiming the law was unconstitutionally vague, lacked an exception to protect patients’ lives and health, and created undue burdens on a woman’s right to access abortion care by limiting their options and forcing many to undergo surgical abortion rather than early medication abortion.

After remaining under injunction as it wended its way through court for the past seven years, the case came before Ohio Federal District Court Judge Susan Dlott, who vacated the injunction and set the stage for enforcement of the law.

Both the law and the court’s decision ignore the medical and scientific evidence regarding safety of RU-486 and create a different standard for clinical delivery of an abortion drug than for other drugs approved by the FDA.  As a result, fewer women in the state seeking to end an unwanted and untenable pregnancy will be able to access RU-486 for early termination and will instead be forced to undergo surgical abortion instead. Moreover, those whose doctors can and do prescribe RU-486 will have to pay more, in some cases three times as much, for the drug: “Strict adherence” to the FDA labeling standards ironically requires administration of much higher doses of mifepristone than data collected since the original FDA approval show to be necessary and effective for inducing abortion.

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