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You Can’t Have it Both Ways: The Interpretation of Catholic Health Policy and the Consequences for Pregnant Women

12:46 pm in Uncategorized by RH Reality Check

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

Republished with permission from Reproductive Health Matters.

“There is only one way to be sure a woman’s life is at risk, that is, after she dies.” — Christian Fiala, 2012

 

A view of Galway Hospital and parking lot

Savita Halappanavar died at Galway University Hospital.

In 1987, the year the first Safe Motherhood Initiative was launched by the World Health Organization (WHO), there were more than half a million maternal deaths annually. The women who were dying were often anonymous and their deaths never recorded or studied. They were mainly from poor and often rural backgrounds in developing countries, such as India. A study in India published in 1999 comparing 100 maternal deaths in a Rajasthan hospital in 1983-85 to 100 in 1994-96 found that: “Most of the women who died in hospital in 1994-96 would have died at home in the earlier decade.”1 What had changed was that they had reached a hospital and were therefore no longer anonymous, but they were still overwhelmingly women living in poverty with little or no access to skilled pregnancy and delivery care. 

Contrast this with the death of Savita Halappanavar on 28 October 2012, a dentist from a privileged background in India, who miscarried 17 weeks into a very wanted pregnancy and died in the maternity ward of a hospital in Ireland, a country with a very low maternal death ratio.2 Savita’s death was anything but anonymous; her name and photograph circled the globe within days of her death and sparked street demonstrations and protests, not only across Ireland but also in many other parts of Europe and in India. Six weeks later, articles and blogs about her death continued to be published in many countries, demands by her husband for a maternal death audit were headline news, and the Irish government has been forced to consider the effects of her death for the law, health policy and the Constitution of Ireland. 

Savita’s death became iconic for a number of reasons. First, preventing maternal deaths has been a global priority since 1987 when the first WHO Safe Motherhood Initiative was launched. Since 2000, reducing maternal deaths by 75 percent by 2014 has been the main target of Millennium Development Goal No.5, and since 2010 it has been one of five main goals of the UN Secretary-General Ban Ki-Moon’s Global Strategy on Women’s and Children’s Health. Hence, maternal deaths have started to be a news item globally, with journals like Reproductive Health Matters carrying studies and the media in many countries where deaths remain frequent, reporting successes and failures to reduce deaths, and individual stories regularly.

Secondly, holding governments accountable for their failure to provide the required services, both antenatal and delivery care and emergency obstetric care, to prevent avoidable maternal deaths has become the subject of public protests by women’s rights advocates, of court cases, including in India, and of hearings by human rights bodies, particularly CEDAW, examining individual cases and making policy recommendations to governments.3

What was different about Savita’s death, however, was the fact that it was also about whether and when to terminate a pregnancy when it is not viable and the woman’s health and life are at risk, and how that intersected in Savita’s case with individual health professionals’ interpretation of Catholic health policy and the law on abortion in Ireland. 

As a committee of the Irish Parliament considers proposals to offer limited legal abortion in Ireland, this paper explores how these issues came together around Savita’s death, the interpretation of Catholic health policy and the consequences for pregnant women.

Preventing maternal deaths as global policy

Maternal deaths, especially in countries where they remain frequent, are getting more and more media coverage. The Millennium Development Goals have made countries with continuing high maternal mortality ratios4 conscious of their shortcomings, and civil society organizations are beginning to pursue justice and even compensation in individual cases. 

In India, for example, a petition for legal redress was filed in the Delhi High Court in the case of Shanti Devi, who died in childbirth in January 2010 after two high-risk pregnancies in which she received delayed and insufficient care. With the first of these two pregnancies, she fell down the stairs and afterwards could no longer feel the baby moving. Induction of the pregnancy was delayed until she required intensive care which, when she finally received it, was inadequate. With her health still very precarious, she became pregnant again six months later, went into labor prematurely at seven months, delivered the baby at home without a skilled birth attendant or any medical assistance, and within an hour after delivery, began hemorrhaging and died. This case ensured that the Court took into account not just the individual death but also the constitutional and human rights obligations of the central government of India.5

Some communities where women are at high risk because of the lack of routine and emergency obstetric care are also beginning to protest against maternal deaths. One such event took place in Uganda where, in May 2011, hundreds of concerned citizens and health professionals stormed the Constitutional Court in Kampala, Uganda, protesting the deaths of women in childbirth, in support of a coalition of activists who took out a landmark lawsuit against the government over two women who bled to death giving birth unattended in hospital.6

Another example from India comes from Barwani district, Madhya Pradesh, India, where there were local protests against 27 maternal deaths in the period from April to November 2010. In January 2011, an NGO fact-finding team found an absence of antenatal care despite high levels of anemia, absence of skilled birth attendants, failure to carry out emergency obstetric care in obvious cases of need, and referrals that never resulted in treatment.7

Events like these are making the governments concerned highly sensitive to criticism. As an upper middle-class woman, Savita Halappanavar would have been highly unlikely to die in India from the appalling treatment experienced by Shanti Devi or the tribal women in Barwani. Yet, ironically, the Indian government was among the first to criticism those in Ireland who failed to prevent Savita from dying. For example, India’s ambassador to Ireland said that Mrs Halappanavar may be alive if she had been treated in India.

Emergency obstetric care, termination of non-viable pregnancies and Savita’s death

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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.”

Here We Go Again: House Proposes Slashing International Family Planning Programs and Reinstating Global Gag Rule

11:57 am in Uncategorized by RH Reality Check

Written by Chloë Cooney 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 recent arrival of Chinese human rights advocate Chen Guangcheng has focused the world’s attention on the scourge of coercive reproductive policies in some countries. Now more than ever, U.S. foreign assistance should be directed toward those working to advance human rights. Yet, once again, the House Appropriations Committee voted to let politics interfere with lifesaving health care for women.

Last week, the House Appropriations Committee proposed to cut funding for international family planning programs and impose harmful restrictions on women’s access to essential health care — including the global gag rule and prohibiting U.S. contributions to UNFPA, the United Nations Population Fund. 

While this trifecta of funding cuts and restrictions now seems par for the course in the House, it comes in striking contrast to new evidence released the day prior by leading health organizations. A report from the World Health Organization (WHO), United Nations Children’s Fund (UNICEF), UNFPA, and the World Bank, once again confirms that birth control and reproductive health services are essential to saving women’s lives around the world. Thanks to these interventions, the report finds, maternal deaths declined by nearly 50 percent over the last 20 years.

As the report’s authors state, “[W]hen governments take a strategic approach to the safe motherhood challenge — by deploying trained midwives, ensuring adequate essential supplies, making family planning accessible and providing timely obstetric care to women with complications, we are getting results.”

In other words, evidence shows that family planning prevents the needless deaths of women worldwide.  One would think this would be cause to sustain or even increase U.S. investments in these programs.

Unfortunately, the House bill contains $149 million in funding cuts and would roll funding levels back to 2008 levels. These cuts would result in nearly eight million fewer women being able to access birth control, 745,000 more unsafe abortions, and nearly 6,000 more maternal deaths, according to recent Guttmacher Institute analysis.

In an effort to find common ground and protect women’s health, Representatives Nita Lowey (D-NY), Rosa DeLauro (D-NY) and Barbara Lee (D-CA), each offered amendments to the bill that would allow continued support for targeted programs. All three were voted down by the House majority (with Republican Representatives Charlie Dent (PA) and Rodney Frelinghuysen (NJ) crossing the aisle to support all three).

That the House majority rejected all three of these compromise solutions reveals the extreme nature of their views and the lengths to which they will go to avoid working with UNFPA.

Critics of the agency claim that UNFPA’s work in China reinforces the Chinese government’s harmful one-child policy and the illegal practices of forced abortion and coerced birth control reported in some localities. In fact, as the Bush Administration’s own specially appointed fact-finding team confirmed, UNFPA’s work to promote voluntary family planning programs empowers women and families and works toward eliminating coercive practices. If we are serious about promoting a rights-based approach to reproductive health in China, we should be supporting UNFPA, not vilifying it.

The House proposal serves as an opening offer in the congressional debate over the FY13 budget.  This week, the Senate Appropriations Committee is presenting and debating their version of the bill, which increases support for international family planning without attaching restrictions that would undercut these efforts. The impact of the decisions made by this Congress will be felt in the lives of women and families around the world.

Pregnancy-Related Death and Illness Among Adolescents & Young Women: A Preventable Tragedy

11:02 am in Uncategorized by RH Reality Check

Written by Imane Khachani for RHRealityCheck.org – News, commentary and community for reproductive health and justice.

This article is published in honor of International Women’s Day, March 8th, 2010.

Approximately 99 percent of the 529,000 annual deaths related to pregnancy and childbirth occurs among women living in low and middle-income countries. Their lifetime risk of maternal death is 1 in 76 live births, compared to 1 maternal death in 8,000 live births in high-income countries. Describing the situation by the word “inequality” would seem indecently euphemistic. But there is another inequality, that of the brunt borne by young women and girls due to pregnancy- and childbirth-related mortality and morbidity, one that public health research, policies and programmes have failed to address.

The World Health Organization (WHO) affirms that while adolescent pregnancies represent approximately 10 percent of all births worldwide–the large majority occurring in low- and middle-income countries–they account for more than one-fourth of the overall burden of disease from pregnancy and childbirth. The 2004 State of the World Population report’s conclusion on that matter is categorical: pregnancy and childbirth are the leading cause of death among adolescent girls and young women in low- and middle- income countries. But the number of deaths alone does not reflect the full scale of this tragedy, another indecently euphemistic word to describe the situation. In fact, for every adolescent girl and young woman who dies from pregnancy or childbirth, 30 more face complications leading to severe morbidities, including injuries, infections, and lifelong disabilities.

So why adolescent girls and young women particularly?

Physiology plays a major role. The birth canals and pelvic structures of adolescent girls are still developing, and their physical immaturity greatly increases the risk of obstructed and prolonged labour, major causes of childbirth-related death and chronic disabilities, including obstetric fistula. Difficult labors put girls at higher risk of post-partum infections and sepsis, other major causes of childbirth-related deaths in low- and middle-income countries.  Poor nutritional status, anaemia, malaria and other conditions further contribute to poor pregnancy outcomes. Additionally, approximately 3 million adolescent girls and young women undergo unsafe abortions every year and face a much higher incidence of complications from unsafe abortion compared to older women.

All of the above causes of deaths and illness are preventable and avoidable.  Dramatically reducing these deaths and illnesses would require concerted efforts to address the multiple, complex and intertwined social and economic factors that hamper access by adolescent girls and young women to information and comprehensive quality healthcare.

Among these factors are child marriage and social pressure to bear children immediately after marriage; lack of access to education and economic resources; lack of access to comprehensive sexual and reproductive health care services and supplies; laws and user-fees restricting access to these services, particularly  contraceptives and safe abortion services and counselling; failure of the available services and healthcare providers to respond to the specific needs of adolescent girls and young women.  These act in synergy, leading to disastrous pregnancy and childbirth outcomes for adolescent girls and young women. 

So where should we start?

Operational research is an essential first step. Better documentation of these issues is critical to determining exactly who, where, when and why adolescent girls and young women are dying or facing severe pregnancy and childbirth-related complications. Maternal Deaths Reviews (MDR) are an effective tool to ensure accurate reporting on pregnancy and childbirth mortality and to provide effective guidance to policy makers for the implementation of cost-efficient interventions. MDRs need to be more youth-sensitive and need to include effective mechanisms to report on the major causes of adolescent girls and young women pregnancy and childbirth related mortality, particularly that related to unsafe abortion. Meaningful community participation – particularly that of adolescents and young people – in the review and development of such tools is crucial.

Legal Action also is strongly needed, particularly to eradicate child marriage, eliminate all the barriers that prevent unmarried adolescent girls and young women from accessing sexual and reproductive health information and services, and make abortion a legitimate right for all women, regardless of age.

Operational research and evidence-based programming need to consider adolescent girls and young women as a special group, outside the usual “15 to 49” age range into which they are placed.  We need to consider the diversity of this group and take a focused but comprehensive approach to meeting the various and varying needs of adolescent girls and young women.

Last, but definitely not least, further funding specifically allocated to initiatives serving adolescent girls and young women’s sexual and reproductive health needs is needed, without creating further verticalisation of programs but with a clear distinction in terms of the populations targeted, the nature of the intervention(s), and management, monitoring and evaluation processes from broad maternal mortality programmes.

Adolescent girls and young women need to become a priority in public health research, legal reforms, development strategies and public health expenditure. Only that way, can our societies overcome these “indecently euphemistic inequalities."