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San Francisco Chronicle: Why can’t we prevent more childbirth deaths? Blame abortion politics

June 13, 2006 / ELISE / In the Media
MM-from-Chron-shadow

Dr. Malcolm Potts and Martha Campbell from Venture Strategies. They aim to “make mothers stronger.” Chronicle photo by Christina Koci Hernandez

 

Image-from-Why-cant-we-prevent-more-childbirth-deaths-sf-chron-story

Nana, 45, founder of Paw Bu La Ta Health Clinic in eastern Karen State, Burma, examines a patient. Photo by Janet Wells, special to the Chronicle

 

Bixby research on misoprostol was featured in the San Francisco Chronicle Magazine, June 2006

Why can’t we prevent more childbirth deaths? Blame abortion politics

By Janet Wells

There are 14 million obstetric hemorrhages a year, killing an estimated 128,000 women, almost all in the developing world, where most births happen at home without skilled medical care. Severe postpartum bleeding is the No. 1 cause of maternal mortality worldwide: One woman dies every four minutes.

Prevention is possible

Nana’s story is the kind that makes Berkeley residents Martha Campbell and Dr. Malcolm Potts throw their hands up in frustration. Not because it’s common. Because it’s unnecessary. There’s a cheap, easy-to-use, safe and effective drug to prevent and treat obstetric bleeding: misoprostol.

Without intervention, a woman with severe postpartum hemorrhage can bleed to death in three to four hours. The blood gushes out, “like cutting an artery” — a terrifying situation for the woman, and for any health practitioner, said Potts, a Cambridge-trained obstetrician and the Bixby professor on Population and Family Planning at the University of California at Berkeley’s School of Public Health.

Developed in the 1980s to prevent gastric ulcers, misoprostol is a hormone-like drug that stops the secretion of stomach acid. An Egyptian obstetrician working in London, Dr. Hazem El-Refaey, posited that the drug could work similarly on the uterus, making the muscle tissue contract, which stems bleeding.

“It is low cost, heat stable, could be given orally, rectally, vaginally. A dream product,” said Potts. “If you give a dose rectally and put your hand on the uterus after delivery, you can feel it contract within a minute or two.”

When asked if the drug might have saved the life of the village teenager, Nana nodded. “If had, not die.”

So why isn’t this drug in the satchel of every birth attendant in the world? Because misoprostol is also a cheap, easy-to-use, safe and effective drug that can induce abortion.

“Governments are reluctant to approve this drug because they are afraid people will use it to do abortions,” said Campbell, a political scientist and health policy expert who lectures at Berkeley’s School of Public Health. While misoprostol is registered worldwide as an ulcer drug, many countries — including Thailand and Brazil — have heavy restrictions on it because of its use in inducing abortions. In Burma and most of Africa, the drug is not available, except, perhaps, on the black market for prices out of most women’s reach.

Potts and Campbell, who are part of a growing cadre in women’s health who see misoprostol as a miracle drug for the developing world, are working country by country to take it out of the political realm. “Countries have made abortion illegal, and we’ve got to deal with that. But one of the things women use for an abortion is a rib of an umbrella or a bicycle spoke, and we don’t make umbrellas or bicycles illegal,” said Potts. “I think it’s immoral not to save women’s lives when they are dying from postpartum hemorrhage simply because they might use (a drug) for abortion.”

The proselytizers

Potts and Campbell, husband and wife as well as colleagues, are too genteel to see themselves as drug pushers. But get them talking about misoprostol, about women’s health, and it’s hard to get them to stop. Campbell headed the Packard Foundation’s population program in the 1990s and co-founded UC Berkeley’s Center for Entrepreneurship in Health and Development. An energetic 65-year-old, she is likely to invite anyone interested in misoprostol by the office for a chat. Potts, 71, teaches classes on contraception, AIDS prevention, international health and violence, and has amassed an impressive — and often controversial — array of accomplishments in women’s health. In 1965, he opened one of England’s first clinics offering contraception to unmarried women. He was the first medical director of the International Planned Parenthood Federation, from 1968-1980. He, along with inventor Harvey Karman, published the first papers on the manual vacuum aspirator, a tool still in use worldwide for abortions and incomplete miscarriages. Potts developed the first comprehensive study of maternal mortality in the developing world, which helped launch the worldwide Safe Motherhood Initiative in 1987.

Potts’ feminist sensibility extended to his work as a historian, as well. “Albert and [Queen] Victoria had a very passionate sex life so she was always getting pregnant to her fury,” said Potts, who wrote a book on the queen and the history of hemophilia. “She put all her own children out to wet nurses, and with a wet nurse, you ovulate very quickly. If she had breast fed, she would have had children much further apart.”

At their north Berkeley house one Sunday afternoon, Potts pulled out scrapbooks from four decades of work in public health. Campbell served green tea, setting the tray on top of magazines and journals like “Population and Development Review.” If asked, one or the other will root through an upstairs room to find a sample of misoprostol. Potts produced a framed black-and-white photo of a pretty, clear-eyed young woman taken in 1900. “My grandmother, who died in childbirth, most probably of postpartum hemorrhage,” he said.

In 2000, with the goal of using technology and research to effect change on a large scale, Campbell founded the nonprofit Venture Strategies for Health and Development. Coincidentally, misoprostol, made by Pfizer Inc. and marketed under the name Cytotec, came off patent that year, which meant it could be made in generic form, and sold for far less. Said Campbell: “My husband pointed out that misoprostol was a huge opportunity for women’s health.”

Getting around the “A word”

Building a case for worldwide acceptance of a drug that has not been approved by the U.S. Food and Drug Administration (or by any European regulatory agency) for postpartum hemorrhage is no small challenge. Especially when that drug is an abortifacient.

The drug used most commonly in the West for postpartum bleeding is oxytocin. Research has shown it to be slightly more effective than misoprostol — by 1 percent. But it has to be refrigerated and injected and costs more, making it impractical for the developing world.

There’s a plethora of evidence supporting misoprostol in the OB-GYN arena, including more than 200 peer-reviewed articles on its use, safety and efficacy. As a result, and because the FDA gives physicians discretion to use an approved drug for off-label use, misoprostol has become part of every OB-GYN department’s arsenal in the United States. It is used here to treat postpartum hemorrhage, to induce labor and to soften the cervix before some procedures and it is part of the medical abortion regimen.

Misoprostol is not risk-free. When used to treat postpartum hemorrhage, side effects can include nausea, vomiting, diarrhea, abdominal pain, chills and fever. Using the drug to induce labor presents an even more serious risk. Misoprostol tablets come in 200-microgram doses, but it takes only 25 micrograms to induce labor (as opposed to 1,000 micrograms to treat hemorrhage). One-eighth of the tablet is “just a speck,” Potts said. While there are now 100-microgram tablets available, and some institutions (such as Kaiser Permanente) cut and repackage them for specific OB-GYN uses, many health practitioners — especially in the developing world — still must resort to cutting the higher-dose pills by hand.

“It’s easy to overdose women,” Potts said. “This drug is so powerful if you give it while the baby is still in the uterus, it can rupture the uterus.” There have been cases of uterine rupture in connection with the use of Cytotec in the United States, and several infants have died in utero as a result, according to the FDA. In addition, there have been five deaths since 2003 in the United States linked to the FDA- approved medical abortion regimen, known as Mifeprex or RU-486 (mifepristone ends the pregnancy, and misoprostol causes the uterus to expel its contents). Four of the five women tested positive for a fatal bacterial infection, although neither drug in the regimen was contaminated, according to the FDA. The fifth death is still under investigation.

Overall, misoprostol’s safety issues have been few, given the drug’s widespread use. Its controversial status worldwide stems far more from its connection to abortion.

Just before the medical abortion regimen was approved in 2000, misoprostol’s manufacturer — at that time G.D. Searle & Co. — fired off a letter to thousands of obstetricians and gynecologists warning them against its unapproved use in pregnant women. Searle has since merged with Pfizer Inc., which has also taken pains to steer clear of the drug’s use in obstetrics. Pfizer, along with several other pharmaceutical companies, declined to manufacture the medical abortion regimen, according to a history of the abortion pill posted on the Legal Education Document Archive managed by the law schools at Cornell and Harvard universities. When the Danco Group was licensed to market the drug, the company shielded the name of the manufacturer willing to do the job.

But politics hasn’t stopped Pfizer from selling Cytotec. A Pfizer spokesman said the company doesn’t “report out sales, it’s so small,” and indicated that it was “somewhere south of about $180 million” annually. (The company’s cholesterol drug Lipitor, by comparison, racked up sales of $12 billion last year.) Pfizer had no statistics available on how much of the drug is sold for off-label use. But more than one doctor made the observation that while there are newer, perhaps better drugs to prevent gastric ulcers, misoprostol is still the top choice for several obstetric indications, and is the only FDA-approved choice to complete the medical abortion regimen.

Some in women’s health circles think misoprostol should be promoted for abortion. While it is less effective than the dual medical abortion regimen, misoprostol alone has a pregnancy termination rate of 85-90 percent when used during the first nine weeks. New York-based Gynuity Health Projects and Reproductive Health Technologies Project of Washington, D.C., have posted instructions on-line for using the drug in obstetrics, including terminating a pregnancy.

“We’re trying to develop (misoprostol’s) possibilities for all aspects of women’s health,” said Dr. Beverly Winikoff, Gynuity’s president. “Some people are trying to keep a firm line between abortion and other women’s health issues. It’s doesn’t make sense.”

Of the estimated 46 million induced abortions that take place annually worldwide, about 20 million are performed under illegal and unsafe conditions, with an estimated 68,000 women dying from complications. According to one study, access to misoprostol doesn’t increase the number of abortions. It makes them safer. The study — co-sponsored by Venture Strategies — showed that in the Dominican Republic, since the introduction of misoprostol in 1986, the rate of abortion-related complications decreased from 12 to 2 percent.

Potts and Campbell agree that abortion is a critical women’s health issue that needs to be addressed, but adding it to the misoprostol debate makes for a much tougher battle. Statistics aside, few government policymakers are going to step up and embrace a drug for abortion, Potts said.

“Giving people contraceptive advice or talking about abortion, there will be controversy,” Potts said. “Stopping women dying in childbirth, that’s a powerful thing. People can empathize with that.”

Indeed, saving mother’s lives is one of the foremost goals in health care worldwide. In its Millennium Declaration, the United Nations and its 189 members targeted a reduction in maternal mortality of 75 percent between 1990 and 2015. Sub-Saharan Africa, where the chance of dying in childbirth is as high as 1 in 16 over a woman’s lifetime (compared with 1 in 3,800 in the developed world), has made no headway in increasing women’s access to the skilled emergency obstetric care the United Nations says is necessary.

“That means a hospital, a gynecologist, a trained midwife,” said Anke Hemmerling, a German obstetrician and Berkeley School of Public Health fellow working with Venture Strategies. “That’s not going to happen in the next 10 years.”

Campbell agreed: “There’s no getting around the fact that without (miosoprostol) you cannot significantly reduce maternal deaths in the settings where most births occur.”

It’s all about gaining access

Venture Strategies was just getting off the ground six years ago when Potts and Campbell met three obstetricians from Kenya, Tanzania and Nigeria at a party in Washington, D.C. “They asked us, ‘Please can you help us get this drug misoprostol in our countries?’ ” Campbell recalled. Campbell and Potts pulled together a multinational team of doctors and researchers for a collaborative effort that turned out to require patience and diplomacy. It meant meeting with ministers of health and government leaders who were skittish about potential political fallout. It meant sensitivity to cultural and religious strictures. It meant learning to design small studies to test the drug’s efficacy and safety in the settings particular to each country. It meant finding drug manufacturers and distributors, and initiating the often costly and byzantine drug registration process.

It was slow going. Then, in 2004, a Venture Strategies’ supported study in Tanzania demonstrated that illiterate traditional birth attendants can effectively administer misoprostol for postpartum hemorrhage. Meetings quickly followed in Kenya, Nigeria and Uganda. The group has facilitated additional studies in Bangladesh, Egypt and Nigeria, and is involved in forthcoming projects in Ethiopia, Afghanistan and Yemen. In January 2006, Nigeria approved the drug for treating and preventing postpartum hemorrhage — becoming the first country in the world to do so. Ethiopia became the second in May. “The logjam,” said Potts, “is beginning to break.”

Venture Strategies has also helped smaller nonprofit groups working to increase access to misoprostol. In eastern Burma, where Nana’s 14-year-old patient died, the maternal mortality rate is one of the highest in the world, with 1,000-1,200 deaths per 100,000 deliveries (compared with about 12 per 100,000 in the United States), according to data compiled by the Global Health Access Program, a Los Angeles nonprofit group. One-third of the women there who die succumb to postpartum hemorrhage.

“The fact that misoprostol isn’t out there is just unbelievable,” said Dr. Tom Lee, one of the program’s co-founders and an emergency room physician from Southern California who volunteers his time on the Thai-Burma border twice a year.

For groups like the access program, doing international public health projects on a large scale via an official government route can be cumbersome, or in the case of Burma, virtually impossible. (The repressive military-controlled government has become increasingly isolated and uncooperative, even when it comes to humanitarian aid: The Global Fund to Fight AIDS, Tuberculosis and Malaria recently terminated nearly $100 million in aid to Burma because of government restrictions on travel, procurement of supplies and unencumbered access to affected populations.) Instead, with the help of Venture Strategies, the group procured misoprostol from a manufacturer in Egypt for 13.5 cents a pill — four times less than it would have cost in the United States — and designed a program to train 43 experienced health workers who could quickly implement use of the drug in Burma. Earlier this year, the health workers learned to use misoprostol in a clinic setting on the Thai-Burma border, and have now returned to their villages. In the coming months, the health workers will teach other practitioners — including traditional birth attendants — about using the drug to treat postpartum hemorrhage.

Three of those health workers are in Nana’s village, which means that next time there is a patient bleeding after childbirth, she has a much better chance of survival.

“The fact that there is a technology that can be used by illiterate traditional birth attendants that makes a huge difference over a very, very large scale is enormously exciting. To us it’s one of the most exciting developments in public health,” Campbell said.

“What we’re really doing is making mothers stronger.”

Janet Wells’ last piece for The Magazine was on Lida Tan, the Environmental Protection Agency’s China coordinator.

This article appeared on page CM – 12 of the San Francisco Chronicle

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San Francisco Chronicle: Open Forum: The pill is mightier than the sword

April 13, 2006 / ELISE / In the Media

pill-is-mightier-imageSan Francisco Chronicle: Open Forum

Monday, February 27, 2006

The Bush administration intends to cut the modest funding the United States gives to international family planning by almost one-fifth. For those of us who are interested in looking 15 to 20 years ahead, this is the dumbest action possible.

The Sept. 11 commission report is explicit: “a large, steadily increasing population of young men without any reasonable expectation of suitable or steady employment [is] a sure prescription for social turbulence.” Every day on TV, we can see that it is predominantly young men who join extremist groups, burn embassies and plant roadside bombs. In Iraq, Afghanistan, Pakistan or Syria, the mean age of the population is between 18 and 19; in the United States, it is over 35. Both liberal sociologists and hard-nosed CIA analysts recognize a link between a high birthrate, a high proportion of young men in the population and the possibility of violence and terrorism.

Just as smoking is a risk factor for lung cancer, so a high proportion of young men in the population compared with older men is a national risk factor for violence. Not everyone who smokes dies of cancer, but many do; not all nations with a high ratio of younger to older men spawn terrorists, but many do. Young men in a sexually conservative society who have no jobs and cannot marry are easy recruits for any extreme political or fanatical religious teaching.

Consider the case of the Black September terrorists who murdered Israeli athletes at the 1972 Munich Olympics. Even Yasser Arafat felt compelled to try to rein in this group of young fanatics, and he did so in an unusual but highly effective way. The PLO offered Black September members who married Palestinian women a flat in Beirut with a television and a refrigerator, together with $5,000 when they had their first child. Black September was never violent again.

For more than 30 years, there has been bipartisan congressional support for international family planning, and voluntary family planning has achieved a great deal. In 1960, South Korean women had six children, the population was growing more rapidly than the economy, and the country was as poor as contemporary sub-Saharan Africa. Without the support the United States gave to Korean family planning in the 1960s and 1970s, Korea might not have the two-child family and 15 times the average per-capita income of African countries it enjoys today

is commonly thought that poor and illiterate people want many children. Those of us who have worked in family planning for decades know this isn’t true. As Korea, Thailand, Brazil and many other countries demonstrate, wherever modern methods of contraception have been made realistically available, the birth rate has fallen — often rapidly. Where fertility remains high, careful surveys always show a significant unmet need for family planning. We have spent our professional lives in international family planning because we know family planning saves mothers’ lives, and we know that in the developing world, babies born less than two years apart are more likely to die. We see abortions increasing in the Philippines where contraception is difficult to get, but decreasing in some parts of the former Soviet Union, where access to family planning is improving. Most fundamentally, no woman can be free until she can decide when to have a child.

But having said all of this, it might seem naive to suggest that family planning could help forestall the next generation of terrorists, were it not for a silent revolution occurring in the Islamic Republic of Iran. In the 1980s, Iranian economists, like their Korean counterparts 20 years earlier, saw that the population was growing faster than the economy. The Quran supports family planning, and the theocracy agreed to make all methods of contraception easily available. In 15 years, average family size plummeted from more than five children to two. A more sober, cautious population of smaller families is replacing the body of radical students. The West may not want Iran to develop nuclear weapons, but in a generation’s time Iran is likely to be more stable than Pakistan, which already has the atomic bomb.

Iran had the resources to build contraceptive factories and to carry family planning into the most remote villages. The poorer countries around the world need exactly the external support that President Bush is axing. It is difficult and costly to make modern urban society invulnerable to terrorist attacks, but relatively easy and extremely low cost to help those who wish to have smaller families. For international family planning (before Bush cut it), each American gave the cost of one hamburger per year — about $436 million total.

Prescott Bush, the president’s grandfather in Connecticut, lost his first election for the Senate in 1950 because he had the courage to support Planned Parenthood. As U.S. ambassador to the United Nations, George H. W. Bush believed family planning was the key to solving the “great questions of peace, prosperity and individual rights that face the world.” Laura Bush has supported family planning in Texas and Mexico. Sadly, the first president Bush sacrificed common sense to ideology in order to become Reagan’s running mate. The second president Bush should take this opportunity to re-establish U.S. leadership in international family planning.

Published in San Francisco Chronicle, 2 27 2006,

To read the article at the Chronicle website click here

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An old drug’s new use will save Nigerian women’s lives

March 28, 2006 / ELISE / In the Media

When a shipment of round, white tablets of the generic drug misoprostol lands in Nigeria this week, that country will become the first ever to allow distribution of this effective, inexpensive and stable drug to prevent and treat post-partum hemorrhage, the devastating bleeding experienced by thousands of women after childbirth.

Backed by technical assistance from a team of researchers at University of California, Berkeley’s School of Public Health, a group of Nigerian health professionals won approval for the drug at a January meeting of the Nigerian National Agency for Food and Drug Administration and Control. Now, the first load of the drug is on its way to Nigeria from the Chinese factory where it was manufactured.

Nigerian-midwives-from-Berkeley-new

These traditional midwives are being trained by UC Berkeley’s Ndola Prata for a study in the use of misoprostol in Tanzania. The drug has been found to be safe and effective in treating post-partum hemorrhage, the life-threatening bleeding that can occur immediately after childbirth. (Bixby Program photos)

“It’s our hope to decrease maternal mortality in Africa in places where there are few resources and few facilities,” said Ndola Prata, a physician from Angola who is a lecturer in the UC Berkeley School of Public Health and heads the scientific research in the school’s Bixby Program in Population, Family Planning and Maternal Health. “Of each 100 women who go into labor in Nigeria, between 15 and 20 will develop post-partum hemorrhage. Although the majority will survive, most of those who do will suffer from severe anemia-related health problems for weeks or months after delivery. This drug will have a huge impact both in decreasing those problems and in preventing maternal deaths.”

Misoprostol has been marketed since 1987 for treatment of gastric ulcers. Although its value for post-partum hemorrhage, or PPH, has been recognized since the early 1990s, the drug has not been distributed in most of the developing countries where maternal mortality rates are highest.

After its patent expired in 2000, interest in misoprostol as a PPH medication surged. Encouraged by initial studies indicating potential benefits in poor countries, a group of leading African obstetricians seeking to bring the drug into their own countries asked for help from obstetrician Malcolm Potts, Bixby Professor in the School of Public Health and founder of its Bixby Program, and Martha Campbell, a lecturer at the school and founder of Venture Strategies for Health and Development, a non-profit organization.

Traditional midwives taking part in misoprostol study

These three traditional midwives in Tanzania are participating in a study of the drug misoprostol, which is considered ideal for use in developing countries. Not only is it inexpensive, but it’s effective, safe and easy to use, and it stores well for many months at room temperature in the tropics.

Since then, the group at Bixby has swung into action on the project: Prata has worked with doctors in Tanzania, Nigeria, Uganda, Egypt and Bangladesh providing technical assistance for trials and other studies; the group is helping to establish plans for the use and distribution of misoprostol in various countries; and several team members are developing educational materials for training traditional midwives in the use of the drug. In addition, Prata and Melodie Holden, an economist and engineer who holds a faculty position in the School of Public Health and is director of operations for Venture Strategies, constructed the technical regulatory application for misoprostol’s approval in Nigeria.

Venture Strategies is also playing a central role in these efforts.

“Some of our work is best conducted through a private organization,” Campbell said. “I founded Venture Strategies in 2000 to draw on theexpertise of the School of Public Health to help low-income people in developing countries.” With the scientific base of the technical team at the school, Venture Strategies has supported policy meetings in three African countries and is organizing arrangements with drug manufacturers and distributors to make misoprostol available.

Misoprostol is a hormone-like drug that rapidly stimulates powerful uterine contractions. In a normal labor, contractions after birth deliver the placenta in a timely fashion and start the process of reducing the uterus back to its normal size. If this process is delayed or fails, the bleeding that accompanies childbirth becomes excessive. By stimulating contractions, misoprostol can both prevent the bleeding before it starts, or stop it after it has started.

Although two drugs, oxytocin and ergometrine, are already licensed for PPH, neither can be used outside of a clinic or hospital setting, as they require cold storage and administration intravenously or by injection by a medically-trained person. In developing countries – where most births take place at home and are unsupervised or attended either by family members or a traditional midwife, who may be illiterate – these drugs are simply unavailable.

Misoprostol, on the other hand, is stable enough to sit on a shelf in a house in the tropics for months. It can be safely administered as a rectal suppository by a midwife, or the patient can swallow it as a pill. It’s inexpensive: The wholesale price of the Chinese shipment headed toward Nigeria is just 15 cents per 200 microgram tablet, which works out to 45 cents for a three-tablet preventive dose, or 75 cents per five-tablet treatment dose. And none of its few side effects – shivering, nausea, elevated body temperature – are life-threatening.

Worldwide, one maternal death – defined as death caused by pregnancy or childbirth – occurs every minute: Ninety-nine percent of all these deaths happen in developing countries. Of the many causes of maternal death, PPH holds the top spot, accounting for one in four. Risk factors for PPH include malnourishment, anemia, poor health and giving birth to many children. In Nigeria, where most of these factors are widespread, PPH is the cause each year of almost 15,000 of the 55,000 maternal deaths.

For now, the Nigerian health agency has approved misoprostol for use in hospitals or clinics only. Within a year, the agency will review this policy. Prata expects that restrictions will be lifted then and the drug will be made available for use by traditional midwives throughout the country. “The ultimate goal is to bring the drug to the place where women deliver,” Prata said. “Our hope is that this drug will become so widely available that all women will routinely receive it, even when they deliver at home.”

Two other members of the School of Public Health faculty who are among the leaders in the Bixby Program’s misoprostol work are Anke Hemmerling, a gynecologist from Germany; and Farnaz Vahidnia, a doctor from Iran. With its many international members, the Bixby group can conduct its work in 14 languages.

Published in UC Berkeley News, March 28 2006

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