WawaRed (wawa means baby in Quechua language) is a pilot project of Cayetano Heredia Peruvian University that provides pregnant women with access to health information through a cell-phone-based interactive system. Women can access for free information about what to do if they have warning signs during their pregnancy such as vaginal bleeding or severe vomiting. The system also provides them with SMS reminders for their clinical appointments and with motivational messages.

The project will soon develop an electronic medical record that will interact with a mobile phone platform. Initially, the project was focused only on health information before the delivery. Given that women expressed their desire to continuing receiving messages to remind them about clinical appointments for their newborn, vaccinations, and nutritional tips, the project is being extended to cover one year after the delivery.

The project is being conducted under the leadership of Dr. García and Dr. Curioso and it is financed by the Mobile Citizen Program of the Science and Technology Division of the Inter-American Development Bank.

Wawared has established strategic alliances with the Regional Government, through the Callao Health Division, and with Telefónica Movistar of Peru. The project has now additional support from UNICEF to include an Electronic medical record for the baby`s first year of life.

Video of the project: WaWaRed: Getting connected for a better maternal and child health in Peru by IDB’s Mobile Citizen

By Saundra Pelletier. Big numbers always make people stop and think. Big birthdays, anniversaries or milestone are moments to reflect on what once was, and what could be.

Over the last few months, media coverage of the population reaching seven billion people has been especially ponderous, causing wonder about what the pressure of so many people will do to our planet. Questions abound. What will the carbon footprint of seven billion plus people be? Will there be enough food to feed everyone?  What can we do about population growth? How many people can the planet manage?

One of the ways we can help our planet is by investing in family planning. Family planning is one of the most cost-effective, high-yield interventions that exists today. Countries that invest in family planning can reap immediate health benefits, investment savings in health and education sectors, and social and environmental benefits that extend well beyond a single generation.

As I wrote in an earlier post, the ability for women here in the U.S. to use birth control to prevent or delay pregnancy gave every woman  the power to decide if and when she wanted to have children, and how many to have. And with the ability to keep families smaller, came the ability to provide for their present and future well-being.

This argument – small-family-equal-prosperous-communities– is not lost in the broader discussion about the seven billionth baby, but while pundits stress the urgent need to reduce the size of the world’s population, nowhere near enough is being done to ensure that the 215 million women who want to use modern contraception have access to do so.

The fact that this amazing milestone has made people stop and think about the people on our planet is a good thing. A good place to start on a road to a healthy, more prosperous planet is to ensure  that the women and girls, who make up just over half of the planet, can make informed choices about if and when to have children, and that they have access to the supplies to allow them to do so. Providing this access will slow the pace to reaching 8 billion.

About WomanCare Global: It is a nonprofit organization working with partners around the world to improve the lives of women by providing access to affordable, quality reproductive health products. The organization believes that every woman, no matter where she lives, should have control over her reproductive health and family planning needs, ultimately improving her ability to care for herself and her family. WomanCare Global closes the access gap by bringing the same quality products available in the developed world to developing countries. WomanCare Global serves both public and private sectors via an established global supply chain reaching countries around the world, with particular focus on under-served markets in Africa, Asia and Latin America.

By Saundra Pelletier. In 1965, Griswold v. Connecticut gave a married woman the right to use birth control to prevent or delay pregnancy as she saw fit. This guarantee of a basic human right led to other reforms that allowed millions more American women to decide the direction of their own reproductive lives.  This summer, we are proud to see another key reform go through: starting next year, the Affordable Care Act will allow even more women in the United States to be in charge of their own health by requiring new health plans to provide free birth control without a co-payment. These are hard-fought wins for women’s health and for women’s rights of which we can all be proud, but sadly the ability of a woman to choose when and whether to become pregnant is far from assured in other parts of the world.

Pause for a moment and imagine you’re not American, but from Sub-Saharan Africa – Ethiopia for example. You are 20 years old and have four children – the first of which you had when you were 15 and newly married. You’re worried about becoming pregnant again. You tried to get birth control once, but arrived at the clinic only to find the shelves bare and no way to access any form of birth control.  The thought of another pregnancy, whether by a husband who won’t take no for an answer, or by a stranger who might force his way upon you while making your way to fetch water for the family is overwhelming. You’re not in great health, and another pregnancy would take its toll on your weakened body. The chances are high that you might not survive pregnancy or labor to be able to take care of your family.

Globally, 215 million women would like to be able to prevent or delay pregnancy, but do not have access to the supplies that would allow them to take control of their lives. As American women, we know from our own experience that the ability to make our own fertility decisions has made an immeasurable impact on our own lives. For women in the developing world, access to reproductive health supplies would save lives and improve health, as well as the economic and social well-being of families and communities.

Consider the staggering number that every single day, 1,000 women die due to pregnancy-related complications. Access to contraceptive supplies would mean that unintended pregnancies would drop by more than 70 percent every year. 150,000 maternal deaths would be avoided every year. And 600,000 children would not lose the love and care of their mothers.

Why is it that a private sector product like a Coca-Cola or a mobile phone can get to ‘customers’ yet much-needed health care information and products are beyond reach? This question has perplexed the global health community for decades.

WomanCare Global was founded in 2009 to address the profound problem of maternal mortality that has challenged the reproductive health field. The path is very clear and one word sums up the problem and the solution – ACCESS.  Our “hybrid” model is trying something new – a way of offering women hope because the emphasis is on access to affordable quality products for the women who need them most.  WomanCare Global recognizes the many challenges facing the distribution of healthcare technologies in underserved markets. All too often, pharmaceutical and device manufacturers decide not to invest in low resource settings, limiting product availability in much of the developing world. Additionally, supply-chain gaps keep products from reaching healthcare facilities, providers, and the women they serve.

By identifying innovative reproductive healthcare technologies and utilizing existing distribution channels, WomanCare Global promotes sustainable access to these critical products.

Family planning is one of the most important, cost-effective interventions available in the world today. Every woman, no matter where she lives, deserves access to the lifeline of information and affordable reproductive health products.

Interestingly, he said he hoped to spend 5-10 years at this site.  He wanted to excavate the bones using archeological techniques, i.e., careful delineation and recording of the exact locations of extracted items, carefully taking down the hillside in 2 meter by 2 meter by 10 centimeter layers using levels and small brushes and tools that looked like they belonged to a dentist, washing all the soil that is removed from the hillside to expose anything that remained of living things, and reviewing all the residue under a microscope back at the Burke Museum in Seattle where he works.

Why does he want to conduct the dig in this way?  Ordinarily, people just want to get the bones out.  So if he comes to a dig after most paleontologists have been there, everything (except the bones) is essentially destroyed.  In one case, he was able to get data from a 5% core sample before the bones were extracted, which gave him unique information that he was interested in, but this sample had all the limitations of any small sample as far as understanding the full universe of data from which it was drawn.  Even with this small sample, though, he was able to create a unique data base that received scholarly notice.

So why does he care?  He replied that most people actually don’t care, which is why this project is self-funded, uses volunteer staff, and occurs on the week-end, when everyone is not at their “day job.”  But exactly what does he want to find out?  The answer is that he wants the full story, or as much of the story as is still available after thousands of years, about what happened around the day the mammoth died.  Did the mammoth die here?  Or were the bones washed here by a flood?  Did they end up here due to a mud slide?  What can we learn about what else was going on at that time by examining the environment around the bones?  Were there rodents (which kinds?), insects, seeds (of what?), nests?  How much of the story of this mammoth can we reconstruct if we do a careful analysis of the site?  In other words, how fully can we describe this particular mammoth’s story?  And what happened before this animal died? What happened later?  The point is that context matters, the story matters if we really want to understand “the bones.”

For instance, one day the paleontologist found a tiny yellow spider in the residue when he examined it under the microscope.  He took the find to the museum staff who specialize in arachnids who confirmed that it was indeed a tiny yellow spider of the type he suspected.  But then he told his colleagues that the spider had to be at least 13,000 years old.  Since his colleagues only analyze spiders from the recent past, this was an amazing finding.  No one knew this type of spider had inhabited that region so long ago.  Some people care. 

I am a Certified Nurse-Midwife.  This man was the first paleontologist I had ever met or had a conversation with.  I listened to this narrative with the ears of a midwife.  I realized early in the conversation that he was using language that I had only heard between obstetricians and midwives prior to this day, where there is a tension between those who “just want to get the baby (bones) out,” hopefully with minimal damage, and with the help of some pitocin (dynamite) if necessary, and those who want to put birth in its social context, who of course want the baby to be safely delivered, but who care about “the rest of the story.”  The latter providers care about how the birth process fits into the larger story of this woman’s life and her family, they care who this woman is, what her culture and values are, who her partner is and what their relationship is, and how all of these affect the context of her birth.  They want to know how all these factors are best considered in educating the woman and planning for her labor and delivery and helping her to be a good mother going forward.  Failing to consider the confounders, the complexities, and the uniqueness of a given situation, they argue, creates an increased risk of unnecessary complications and unintended consequences.  Spending the time to understand the context creates increased safety and improved outcomes.

Currently, the American culture surrounding birth de-values the individuality of a pregnant woman and minimizes the importance of her individual story.  The predominant place of delivery is the hospital with an obstetrician in attendance. Women are routinely told that as long as the baby is delivered more or less safely, that’s all that matters.  Hopefully, any collateral damage to mother or baby is within tolerable limits so that no lawsuit ensues.  But as long as the mom and baby remain reasonably healthy (or recover from a major complication), the story women are told is that there really is no downside to extracting the fetus by the most convenient means available, whether convenience for the mother or for the provider or for the hospital or for all three.

However, in the field of maternity care, it has long been recognized that “the story” does matter.  In a ground-breaking study to show this, Penny Simkin’s 1991 study entitled “Just another Day in a Woman’s Life? Women’s Long-Term Perceptions of Their First Birth Experience,” demonstrated that six weeks after delivery, women remembered in detail, i.e. word for word, what was said to them by people while she was in labor.  How the woman was treated was a much more significant predictor of satisfaction with the birth experience than the manner of delivery, the number of interventions, or even the correlation with her birth plan.  More importantly for this discussion, when the woman was administered the identical questionnaire 20 years later, her responses were virtually unchanged, even to the point of using the same locutions to describe events.  In several cases, Simkin was able to show how the birth experience had lifelong consequences for the mother.  But, to put it simply, health care reimbursement policies do not pay providers to consider the full story, either prenatally or during labor.  The work that midwives do to understand the context within which a particular birth is occurring is volunteer work.

This tension between maternity providers has probably always been present to some extent, and reflects in part the underlying difference between medicine and many forms of “nursing” care, including midwifery.  Physicians are trained to identify a problem and fix it; nurses going back to Florence Nightingale are trained to consider the context and prevent the problem from occurring in the first place, using education and also management of the environment.  The current financial pressure on all health care providers to perform more billable procedures provides the impetus to “cut (sic) to the chase,” to forego making the effort to spend much time with women prenatally, and to spend even less face-to-face time with them during labor. 

Essentially, the health care system pays for completing tasks, not for considering “the story” in order to achieve a better long-term result.  This leads to the kind of fragmentation of our health care (non-)system that results in safety issues.  The National Priorities Partnership has recognized that patients are at increased risks at those points in their course of care when a hand-off is required, whether it be from home to emergency room to hospital room to operating room to skilled nursing facility, or just from one shift to another.  Being cared for by providers who do not have the full story is a leading cause of safety issues for patients.  For example, the Atul Gawande’s Checklist Manifesto gives examples of how even so small a thing as having everyone in the operating room know the name of the operation and where the incision will be made increases safety for the patient as compared to usual care.

It quickly became apparent that I had experienced a sea change as a result of listening to the paleontologist.  For instance, it so happened that the conversation with him occurred the afternoon of the day that Osama Bin Laden was killed.  Two days later, I was listening to National Public Radio, and heard a story about the difference between those military units that are anti-terrorist and those that are anti-insurgency.  The anti-terrorist units just want to be told who and where the bad guys are and they will kill them.  The anti-insurgency units agree that the bad guys need to be killed, but they also recognize that just killing one terrorist might spawn fifty more, in which case the net effect is the creation of an additional 49 terrorists.  For the anti-insurgency units, then, the context or “the story” is at least as important as the terrorist.  They ask questions like, given the context, what is the best way to take out the bad guy?  When should it be done, including time of the year and day of the week?  Where?  What ancillary issues need to be considered? How should we plan for (what) contingencies, given the context in which we are operating? How will we “spin” the story once the terrorist is killed?  In other words, the plan for addressing the contextual factors is as important as the tactical plan for taking out the terrorist.  It was clear from the speech that President Obama made that night that he had fully considered the contextual factors and planned for them—perhaps not perfectly, but well—in advance.

When I described pieces of this discussion to a very successful stockbroker who specializes in managing retirees’ portfolios, she immediately knew what I was talking about in her field.  As she pointed out, some sales people make the sale—any sale—by whatever means are available and convenient at the time.  This approach has many obvious benefits in the short run. Other sales people take a more deliberate and time-consuming approach.  They understand that taking the time to truly understand the needs of the client, to ask enough questions to know what the client is able and willing to do and to ensure that all of the client’s questions have been adequately addressed is very time consuming. But the necessary resources to get “the story” in all its complexity and irrationality pays off in the long run in the form of increased respect for the sales person, improved client satisfaction with the transaction, and greater likelihood of repeat business.  Further, the latter approach increases the chances that the client will market the sales person to friends and family.

Suddenly, I am wondering how many more aspects of my world can be divided into “get the bones/baby/terrorist out however—it’s just a day” or “understand the context and get the whole story before you make a plan or act, then proceed with caution—this may have serious consequences.”  Like any dichotomy, this characterization is overly simplistic.  But in this day of instantaneous communication of 140-character tweets and 160-character texts, it behooves us to remember that “the story” counts, perhaps more than we task-oriented people like to think, and it is worth the time and effort to get it right. 

VSI is a California-based nonprofit organization committed to improving women’s health in developing countries by creating access to life-saving and affordable health solutions for all. Their largest safe motherhood program brings life-saving generic tablets to rural women for management of excessive bleeding after childbirth, or postpartum hemorrhage. VSI has assisted 17 developing countries in the integration of life-saving maternal health solutions, trained over 18,000 health care providers on safer childbirth, and educated over 130,000 women and their families on safer childbirth.

Here is one mother’s story…There are many faces of motherhood.  Mariye from Ethiopia is both a mother to her own seven children as well as a mother to the countless women she helps through labor and childbirth.  She confidently fulfills her role as a traditional birth attendant (TBA) in a world that often overlooks the importance of these essential community health workers.  Mariye is a vital resource to the women in her community, providing care and compassion to women who deliver at home, who would otherwise be alone. Her strength and her wisdom are derived from her own experiences in childbirth and her own inspirational story.  Mariye’s first child was delivered stillborn.  As time passed she grew weak and began to realize that her afterbirth still had not come.  In order to save her own life, she found the strength to pull out the placenta herself, thereby saving her own life. Mariye sees her story as a gift. Without strong and supportive women like Mariye, VSI’s work to reach women at the margins would be left unaccomplished.

Maternal Mortality Facts:

• Each year, over 340,000 women die of causes related to pregnancy and childbirth; 99 percent of these deaths occur in developing countries.
• This means that every 90 seconds, a woman dies in pregnancy or childbirth. This is unacceptable and preventable.
• In many developing countries, large numbers of women deliver at home, sometimes alone and many without the aid of a skilled attendant.
• Because women are social and economic providers, saving women’s lives and improving their health strengthens their communities and gives their children greater security.
• In Ethiopia, 94% of women give birth at home.  And only 6% of births are attended by a skilled provider.
• In the communities that VSI serves, becoming pregnant is one of the most dangerous things a woman can do.

For more information on VSI including how to become involved in their efforts visit: http://www.vsinnovations.org/.

The firestorm that followed created some heat but none sufficient to help relieve the shivers. Others might declare the outcome a “win” but the more I read, the worse it seems. I’m not privy to what really happened, only what the press reports. It does not look good… for virtually anyone of the players involved, especially the critics. 

Those critics raised tough questions and to date only the company has faced them. It’s about time the critics themselves –and perhaps others as well – face some.   

For those who’ve missed the story, on February 3, 2011, the FDA approved a drug intended to reduce the risk of certain pre-term births in women who’d already had at least one pre-term birth. 

In truth, a number of treatments are already available for women in this situation. None of them sound easy. They include certain other medications (including IV medications) and restricted activity (like bed rest) that prevent women from going to work, making meals or providing care for other children or family members. Oh, and they can’t have sex, either. In some cases, women are hospitalized and, when all else fails the birth is premature. If they survive, the babies then receive care in neonatal intensive care units at the high costs we all know and frequently bemoan. 

One of the treatments already available was an injection that compounding pharmacies—perhaps one down the street from you—made at a fairly low cost. Though there is no indication the FDA had concerns about this particular pharmacy-compounded product, the American Journal of Perinatology in March 2009 reported on a study of OBs saying they were “very concerned;” apparently it made care for these women more difficult. Perhaps understandably, the women did not want to take a product the FDA had not approved. Add to that, other FDA studies had indicated a third of pharmacy-compounded products (in general) had doses higher or lower than the physician prescribed. Perhaps that is why FDA was interested in a product they could regulate.     

NIH had been interested, too, had studied the drug in question and apparently found it was effective and prevented premature labor. 

Somehow a company got involved, but then it sold its rights to another company. Press reports don’t say why. That second company bought the rights, paying $92M up front and promising another $107M in payments over time. 

The second company then committed over $250M, including more than $60M in research and clinical trials involving multi-year follow-on studies of 1,700 mothers and 500 babies. The second company says the studies were four times larger than the previous NIH studies and twelve times more expensive. When it appeared the FDA would approve their version, they built relationships with specialty pharmacies to make sure that patients could get access, set up patient assistance programs and started the launch. 

All hell broke loose when the price was announced – a price not worth talking about now, though it may well be justified on several grounds: 

• The company invested substantial funds to buy and then further develop the drug;  
• The company pursued FDA licensure, which is costly and come with no guarantee of success; and  
• The company, unlike compounding pharmacists, will likely be held legally liable for any problems related to the use of the product, including any claim that it was not safe or was not effective in preventing some premature births. The company will also liable if decades from now the product comes under suspicion for consequences no one can imagine today.   

And let’s not forget as well that a week’s supply of the drug is probably cheaper than one day in a NICU, making it cost-effective by keeping babies with Moms longer and out of NICUs. 

The firestorm resulted in company policy changes: a price reduction of 55%. The company will as pay Medicaid rebates and in addition a supplemental Medicaid rebate of 32.1%; it will cap the cost for insurers and Medicaid and will remove income caps required for women to qualify for patient assistance programs. Going forward, 85% of patients will pay less than $20 per injection—essentially what they were paying before for an untested, unapproved, unregulated, uninspected product. 

I don’t know this company or anyone in it and as near as I can tell, their biggest mistake was not preparing everyone in advance for the initial price. As I think about them today, I imagine they’re reeling: share prices were down 48% at one point and finally “settled” at a 20% decline. No good deed goes unpunished, it seems. 

To make matters worse, FDA says it “does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually-identified patient, unless the compounded products are unsafe, of substandard quality or are not being compounded in accordance with appropriate standards for compounding sterile products.”  I’ll bet that felt like a “kick in the gut” back at the company. 

I wonder if those company folks wake up some mornings – or in the middle of the night – wondering why they bothered. 

Some senators have called for an FTC investigation and, who knows, even Congressional hearings might result. This is far too juicy a political issue after all and we’re nearing an election. 

Since the company has already addressed their issues, I’ll offer some issues for the panel to consider when they speak with the others involved. They’ve “got some explaining to do” as well. 

For NIH: 

• If the NIH study was adequate to secure FDA’s review, why didn’t NIH itself pursue licensure? FDA offers special help for those unaccustomed to pursing approval; NIH could have availed itself of that help. Why didn’t it? 
• If approved, NIH could then have licensed the product to any number of companies, including generic companies, who could have manufactured and delivered it to pharmacies for dispensing and probably at substantially lower prices given that private company risk and investment would not have been involved. Did NIH consider that option? If not, why not? What might the price have been if the NIH had taken that route? Further, any licensee would have played royalties back to the government? What amounts would have been returned to taxpayers had NIH followed that route? 
• NIH has recently decided to pursue the drug development arena, filing in gaps it feels the private sector last left in its wake. Would this product have fit the profile for such an effort? If  so, and this was such an “easy target”, why didn’t NIH pursue it when it had the chance? If the NIH was not capable of pursuing such an apparently easy target, how can it now be trusted to try with other, more challenging therapies?  
• What other research studies of this type has NIH conducted (or is it now conducting) that might result in a similar outcome? Are there other companies who should be prepared to face the backlash from using NIH research or research collaborations to pursue licensed therapies,  including rare disease therapies?  
• What protections will the NIH put in place to assure this does not happen again? 

For FDA: 

• If FDA had such confidence in the ability of compounding pharmacies, why did the agency encourage a company to pursue the additional studies and activities to secure licensure? 
• If there was no public health need for an FDA regulated product, why did the agency go to the trouble to grant Orphan Drug Status, review the filing under the accelerated approval program and grant it expedited review? Why didn’t FDA turn its limited resources – and those of industry – to other, more important, drug treatments?  
• If NIH studies were adequate, why did FDA require more studies of the company? What then was the purpose of the unnecessary research required of the company, research costs which obviously had an impact on the price of the product? 
• After having previously expressed concerns about the quality of compounding by pharmacies, does the FDA decision against enforcement in this case seem inconsistent and even mean-spirited?  
• Does FDA’s decision against enforcement apply to other medications? If so, to which other medications? Which otherwise patented or unpatentable-but-Orphan Drug-designated products will not receive enforcement action protections regarding pharmacy compounding?  
• Should companies, as they figure the future of enforcement into the mix of product development decisions In the future, assume that FDA will suspend enforcement actions when NIH funds are involved in preliminary research?   

Congress: 

• Congress granted companies market exclusivity on drugs for rare diseases and for compounds that might otherwise be unpatentable through the Orphan Drug Act. This provision is one of the drivers of successful of the Act’s components. Does Congress now wish to reverse the terms of the Act?  
• If so, will products currently under development be grandfathered and can those academic institutions and companies who invested in good faith to proceed do so knowing the terms of the old Orphan Drug Act will apply?  

For Drug Developers: 

• Developing drugs for rare diseases is a cousin to personalized medicine, touted as the “next generation” of advancement for public health. Will this action play a role in how your companies approach personalized medicine projects? We all know these products will be more costly. Can you envision a market willing to pay?  

For Orphan Drugs Developers: 

• For PhRMA member companies – currently with over 450 drugs in development for rare diseases – will the facts in this case align with those of projects you have underway? Does this change your commitment for moving forward?  If you need to pull the plug on a project, will this event increase the likelihood that one or more of those will before rare diseases? 
• For BIO member companies who no doubt are developing biological products for rare diseases (sorry, but I can’t find numbers on the products in development for rare diseases by BIO members), do any of the facts in this case align with those of projects now underway? Does this change your commitment for moving forward?  

For Academics: 

• For academics working in labs with NIH funds (most likely), hoping not only to find treatments and cures to but to license those to companies at sometimes lucrative rates for yourselves and your institutions, how does this sit with you? Afraid you’ll get caught in the crossfire?  

For the rest of us: 

• Are we willing to sort through the facts, learn the details and suspend harsh judgments awaiting the right time to pass judgment? Or are we willing to allow policy makers bully the very people who are trying to make our lives better? 

Who was right? Who was wrong? I don’t know. I don’t have all the facts. I’m living with the ambiguity. But I do know some things from experience:

• Drug development is risky.
• Drug development for rare diseases is riskier still.
• NIH research is not always good enough for FDA purposes.
•  FDA resources are limited.
•  It all costs more than most of us know.
•  It’s easy to see only part of the issues and ignore many of the others.
•  It’s impossible to please Wall Street, Main Street, Capital Hill, regulators, clinicians and patients.

Lots of people made some choices these past few weeks. Rather than wait to sort it all out, far too many went witch-hunting, it was not a fair fight for the company involved and it sent a clear signal, not just to the one that shepherded Makena all the way through to eventual approval but to all the others as well.

Bundle up orphans.  It may be spring for others, but a long winter is on the way for us.  

We awardees have been asked to speak briefly about “… how times have changed (or not) for women over the years.”  I would like to do this from two perspectives, first that of the management of the childbirth experience in the 1950′s when my son, Douglas, was born and also from that of the acceptance and utilization of midwives in this country in a similar time frame.  Keep in mind that my husband, Bill and I are “children of the Great Depression” and were taught to live frugally and to care about folks less fortunate than ourselves.

BIRTH IN THE 1950′s was often managed by the routine use of Demerol, a pain killer and scopalomine, an amnesiac, so that women would not “remember” the experience.   Laboring women, (there were no family members permitted), were restricted to a bed with padded side rails so their erratic drug-induced behavior would not harm them or their fetuses and when moved to the delivery room, had their hands cuffed in leather bracelets to the side of the delivery table so that they could not touch their “clean” baby with their “dirty” hands.  How destructive of a  mother’s instincts to hold and provide needed bonding with the new baby!  And how destructive of her perceptions of her ability to be a “good” mother when she might have vague memories of her negative behavior in labor.    Today, there are differing settings to cater to the mother’s and family’s  choices, with the nurse-midwifery operated freestanding birth center being the one with which I am most familiar.  The original Childbearing Center in Manhattan’s Carnegie Hill neighborhood was set up to offer sensitive care to young families who, disenchanted with conventional care, were engaging in “do-it-yourself” home birth, with little or no prenatal care and fathers catching their babies, a potentially very unsafe plan.  The success of the CbC evoked a response from hospitals in the form of in-hospital birth rooms, which, for the most part convert to standard delivery rooms and, even when fathers are present, usually do not offer any control, or even partnership, to the laboring family.

I would be remiss not to mention today’s rapid growth of cesarean section in the United States (from 10.4% of all deliveries in 1975 to 31.8% in 2007) which not necessarily cause, but is but certainly coupled with, an alarming increase in maternal death rates from 6.6 deaths per 100,000 live births in 1987 to 13.3 deaths per 100,000 in 2006.  Amnesty International, which last week conducted a briefing on the House side of the Congress,  reported on this phenomenon in its recent publication,  “Deadly Delivery: The Maternal Health Care Crisis in the United States”

MIDWIFERY: In the 1950′s,  the last of the “foreign” midwives were being prohibited from practicing, and prepared nurse-midwives from one of the 8 schools, including Yale, Columbia and Hopkins, (in addition to the Maternity Center Association’s first school which was opened in 1931), had barely a toe-hold.    Indeed in some hospitals, a nurse did not acknowledge her preparation in midwifery; job loss could result.   In the ‘60′s, there were very few jobs in midwifery and then in 1971, a Joint Statement developed by the American College of Nurse-Midwives and the American College of Obstetrics and Gynecology was put into effect.   Jobs increased very little, but licensure became more available.  Then, in 1975, the freestanding birth center came on the scene and offered a home for the midwifery model of care which you will see when you accept our warm invitation visit the Family Health and Birth Center at 801 17^th St. NE!!  Hopefully, health reform’s attention to nurse managed centers will enable the opportunity to visit others as well in the District, which has the highest infant mortality and maternal mortality rates in the country—right here in our nation’s capital!!   The success of the FHBC, with its midwives, nurse practitioners, breast feeding peer counselors and community outreach workers, placed as it is in a collaboration with case management and early childhood education, is becoming legendary in its service to the primarily African American families seen, those with the worst of the so-called “intractable” infant outcomes.  FHBC outcomes for 2006 include reduction of pre term birth by 2/3, low birth weight by 3/4 and cesarean section by 2/3, while providing evidence of cost savings greater than its operating expenses of over 1 and ½ million dollars .  But most important is the empowerment of the women to take charge of their health and the health and lives of their families, bringing the unrealized talents of the African American 12% of our population to the forefront, and doing so through the provision of respect to those women who are so often disrespected by health care providers.   How else, Ladies and Gentlemen, will the United States be able to compete in a global economy?

Thank you!

When I set up The Developing Families Center in Washington DC’s Ward 5, it was with the goal of addressing this very issue, particularly from the point of view of infant mortality.

At a rate of 12.22 per thousand live births, the District has the highest infant mortality of any of the states, with only Mississippi, at 10.74 also experiencing a double digit rate.

What a tragic loss for our planet when at the same time we in the developed world have turned our attention to new ways of obtaining and sharing information, the latest methods to prolong our lives and even how to conceive and deliver babies well into middle-age. I’m guessing that the founders of International Women’s Day probably hoped that 99 years later, the chances of women dying of pregnancy-related causes would be slim to none.

A new study out of California shows that maternal mortality is hardly something we have conquered in our own country; in fact women die after childbirth at a greater rate in our country than in 33 others! Over the past decade, those statistics have grown increasingly grim in California — rising from 5.6 deaths per 100,000 to nearly 17 deaths per 100,000. The reasons for maternal mortality in the U.S. and around the world are complex and varied, but the fact remains that most of the deaths are preventable. Women simply don’t have to die during pregnancy, childbirth or soon after.

Maternal deaths in developing countries could be slashed by 70% and newborn deaths cut nearly in half if the world doubled investment in family planning and pregnancy-related care, according to a report released two months ago by the Guttmacher Institute and UNFPA, the United Nations Population Fund. The new report, Adding It Up: The Costs and Benefits of Investing in Family Planning and Maternal and Newborn Health, found that investments in family planning boost the overall effectiveness of every dollar spent on the provision of pregnancy-related and newborn health care.

The thousands of delegates from around the world who will gather in Washington this June for the Women Deliver conference are determined to put maternal health high up on the agendas of leaders of nations large and small, developed and getting there. Their ask: $10 billion in additional funding for global maternal health annually, increasing ton an additional $20 billion by 2015.

We mustn’t let this critical discussion get bogged down in ideology about abortion or contraceptives or politics. I challenge you to look into the eyes of your own mother or sister or daughter on March 8 and say, “Sorry, maternal deaths are simply not a prority.” Or you could join me in celebrating International Women’s Day with a pledge to invest in the health and well-being of women.

Amid Death And Destruction: New Life In Haiti

Despite the grim scene in Haiti, life, for some, goes on. NPR’s John Poole and Joanne Silberner have been embedded with the Massachusetts 1 Disaster Medical Assistance Team in a field hospital in Port-au-Prince.

Obstetrician Anne Kathryn Goodman oversees births at the Health and Human Services field hospital. As of Friday morning, Jan. 22, six babies had been delivered at the field hospital. Poole and Silberner were there to document the delivery of little Sampson Brazile.

Hear Silberner’s story:
Download audio file (NPR_20100123_wesat_02.mp3)

View photos on NPR’s Picture Show Blog

Although Sampson’s parents were relieved after 2 1/2 hours of labor, they look to the future with anxiety. The father, Tony Jean, used to work in a textile factory before the earthquake. But the factory has collapsed and he and his wife do not know what they will do after they leave the field hospital. The Haitian government plans to move 400,000 earthquake victims from the shattered capital to camps in outlying areas in the coming weeks. In the meantime, earthquake relief continues to trickle in slowly.

— Claire O’Neill

Source: NPR’s Picture Show Blog

Welcome to the first entry of the book I’ll be publishing in 2010 entitled: You gotta laugh: Life in the trenches of the health insurance business. Because I think Disruptive Women readers will find it useful, each month I’ll post an example of a health insurance problem that is so maddening and frustrating that we just gotta laugh at its absurdity.

My goal, however, is to find a way to improve health insurance for beneficiaries and I have some suggestions at the end of this post.

This month’s question: What do you do when you have it in writing from your insurance company that you have maternity coverage — but when you go to use the benefit, the customer service department tells you otherwise?

The situation: When our client, Ms. R, found out a few years ago that she was having a baby she was thrilled. Immediately, she called the insurance company to confirm her pregnancy benefits. Making the call was merely a formality. When she originally purchased the policy, she was single and didn’t opt for the maternity rider. After she got married, she added maternity coverage because she wanted a family.

Indeed, when she called the insurance company, they confirmed she had the insurance she needed. However, after her first OB check-up she received a letter saying she was, in fact, not covered.

Panic ensued, followed by a slightly hysterical call to my office. We quickly phoned the carrier, and unfortunately it took two weeks of repeated calls to get the information we needed. Finally, we received an email from a reliable supervisor confirming that the rider had been added and she was covered.

Three years later, Ms. R became pregnant again. Following proper protocol, she again called the insurance company to notify them of her second pregnancy. She was told she had no coverage. Surely this was a mistake. She hung up, composed herself, and called back.

This time another agent told her she had dropped her maternity coverage the day her first child was born. Frustrated and confused, Ms. R called me. Who would drop their coverage while giving birth? The only person who can drop coverage is the one who is insured. I don’t know about you, but I was not calling the insurance company during my 27 hours of labor.

Ms. R saved an email from the insurance company stating that she had coverage prior to getting pregnant the second time. Although the letter clearly stated that she had maternity coverage, it took three people making nine calls for four weeks to get a definitive answer ­— that Ms. R did in fact have coverage and the policy would pay for her delivery.

What we never did discover was why the coverage was dropped in the first place. Who authorized the change? And why did it take so long to resolve the matter? You gotta laugh.

Here’s how you can take control

What can you do to make sure a situation like this doesn’t happen to you?

1. When you are thinking about getting pregnant, call your broker or insurance carrier to confirm that you are covered.
2. Make sure to get the name and telephone number of the person you spoke with, the department and supervisor’s name and telephone number, and the reference number for the call.
3. Always write down the date and time that you placed the call.
4. When buying a policy, if you are of childbearing age, be certain that you are covered for maternity.
5. Get a copy of your contract and review it carefully to be sure you are covered for all future potential situations.

If I were the health insurance ambassador

If I were in charge of health insurance policy, I’d make sure that every carrier clearly outlined and explained what is covered in the policy. When amendments are made, policies should be updated, customers notified, and changes posted on the insurance company’s website using easy-to-understand language.

Too often, this information is buried in the policy and is difficult — if not impossible — for consumers to understand. I’d also make sure that carriers were required to respond to issues like Ms. R’s within 48 hours.

Why are childbirthing centers in this country struggling to survive when they ought to be spreading? We know that they provide a wellness-model of pregnancy and birthing (as opposed to a disease model that hospitals have traditionally taken), use best practices in birthing, have excellent clinical outcomes, and save money. Staffed and usually managed by certified nurse midwives, childbirthing centers have been endorsed by the American College of Obstetricians and Gynecologists.

At the end of the Bush administration, someone in the Centers for Medicare and Medicaid Services realized that there was no mandate to pay these centers a “facility fee” that provided support for overhead. So, after years of paying this fee, CMS stopped paying it to childbirthing centers and now pays it only to hospitals.

The numbers I’ve seen suggest that a vaginal delivery in a hospital costs 5 to 6 times more than in a childbirthing center. Ruth Watson Lubic, one of the pioneers of the childbirthing movement, founder of the Family Health and Childbirthing Center in Washington, DC, and a Disruptive Woman, has estimated that using these centers for just Medicaid births could save the nation $1-2 billion each year.

As our nation struggles to figure out how to pay for reforming the insurance industry, we can start to reform health care delivery in affordable, quality ways by ensuring that all pregnant women have access to the childbirthing centers. For those who want to act now, you can sign a petition calling for restoration of the Bellevue Hospital center. Or learn more about legislation to require CMS to restore the facility fee to childbirthing centers.

Even so, I probably wouldn’t take on the Pope…except for an article in today’s Washington Post. Apparently, the Vatican’s top bioethics official said the two Brazilian doctors who performed an abortion on a nine-year-old rape victim “did not merit excommunication, because they acted to save her life.” HELLO! In my book, that’s called a pro-choice stand. Bravo for Archbishop Rino Fisichella, president of the Pontifical Academy for Life. Perhaps he should have a chat with his boss.

Abortion is not a black and white issue for me, despite having worked for the better part of a decade for Planned Parenthood Federation of America and NARAL on reproductive health issues. That’s why the pro-choice position has also seemed to me to be the reasoned one. It allows individuals to make decisions and encourages each of us to define for ourselves what is reasonable and acceptable. There is a trust factor in being pro-choice. For example, if there is the possibility that a nine-year-old may be raped by her stepfather, you want to believe that the pregnancy will be ended as swiftly and humanely as possible.

Good for Archbishop Fisichella for being able to see that issues related to reproductive health have gray areas! And that it is often possible to be both pro-life and pro-choice while having to accept difficult decisions. Is it too much to hope that Pope Benedict XVI might also see the light? If he truly listens to the people of Africa and other continents, and opens his eyes to their hopes for their own lives – I have faith that he may begin to understand the healing power of condoms and the life-affirming necessity for legal, safe abortions.

Since the goal of most fertility treatments is to get one healthy baby — doctors usually implant a smaller number of fertilized embryos.

Let’s start with some numbers.

* Number of women ages 15-44 with impaired ability to have children: 6.1 million
* Number of women who’ve ever used infertility services: 9.2 million
* Number of married couples that are infertile: 2.1 million
* Number of women using infertility services: 9.3 million

These figures, from the National Center for Health Statistics, are a bit dated, but hopefully all of you OB/GYN practitioners and staff out there get the point. A good number of your patients are likely infertile. We’re not very noticeable because many of us walk around in silence, often with serious mental anguish over our inability to conceive. But we’re here. I’d just like you to keep that in mind.

My introduction to this whole world was abrupt and painful. I was about two months shy of my 38th birthday and my husband and I had been trying to conceive.

After yet another test in a series over two months, I expected to come back with my husband and discuss the results. But the doctor decided to talk it over right there and then. It would have been nice to have a heads up so I wasn’t completely alone when she dropped the boom.

“Well I don’t believe in beating a dead horse,” she said. “I recommend IVF with donor eggs.”

It took a minute for this to penetrate my brain. Was she telling me I was infertile?

She then asked if I wanted a list of egg donors to peruse. In a daze, I said “Ok,” and they handed it to me as I walked out of the office. I felt like I’d stepped into “Brave New World” or “Gattaca.” The donors were listed by nationality, ethnic background and level of education. So I could order up a gene pool as if I were in a cafeteria? Was that supposed to console me?

I finally got to my car, called my husband, and broke down sobbing.

I won’t go into detail over my guilt about what I might have done to damage my fertility or whether I waited too long. And won’t digress about why, after many discussions, we decided not to follow the path of fertility drugs and in vitro fertilization. I’m just revisiting all this to give you a sense of how emotionally devastating a diagnosis of infertility can be.

After several years, and a move from New Orleans to New Mexico, I thought I had moved on emotionally as well. Then my insurance company dropped the provider where I got regular ultrasounds. I have uterine fibroids that my OB/GYN monitors by sending me for ultrasounds about twice a year. So I went to a different provider recommended by his office.

It’s one of those places that gives expectant mothers 3-D images of their children in utero. So yes, babies are their business. It’s their marketing niche. I get it. But it didn’t make it any easier.

As I sat in the waiting room, I gazed at the black and white photos on the walls. The pregnant women were ethereal, serenely happy, sometimes holding a baby, sometimes looking dreamily at their perfect, round bellies.

When I got into the exam room, I found several of those Anne Geddes photos of babies dressed up like flowers on the back wall. I looked in front of me. A plaster cast of baby feet was framed on the wall opposite the exam table. I turned to the side. A bulletin board was full of ultrasound images that showed babies’ faces very clearly. As I lay back on the exam table and looked up, a children’s mobile beckoned from the ceiling. There were even photos in the bathroom where I had to go to empty my bladder for the second part of the exam.

I started to feel trapped, even panicky.

As the technician ran the ultrasound over my abdomen, I watched the indecipherable images on a screen over her shoulder. She even showed me the 3-D version. I realized that most of the time, she was probably showing women and their partners their child’s heartbeat up there, or pointing out its fingers, its face, its toes. I felt a profound sense of loss. I’d never been assaulted by these thoughts before because my previous X-ray provider didn’t cram the waiting and exam rooms with images of babies and pregnant women.

I kind of lost it by the time I got back to my car. I also felt like I couldn’t really say anything. Their whole business was built on pregnancy ultrasounds and showing parents their babies’ faces rather than indistinct blobs on a black and white screen. Who was I to protest?

But I finally found my voice on a subsequent visit to my OB/GYN. (Remember, we still have to go every year, or more, even if our uterus hasn’t fulfilled the destiny society calls for.) As I sat in the waiting room, I flipped through the stack of magazines. Every single damn one had to do with parenting or children.

When the nurse took me back to the exam room, I asked why they didn’t have a wider selection of magazines in the reception area.

“You know, it’s really painful for people like me who can’t conceive to come here and find nothing but reminders of how many other people are having kids,” I told her. “Women do have other interests besides family and children.”

She actually took my comments in stride and asked me what other kinds of things I’d like to see.

“Anything!” I exclaimed. “Smithsonian, Time, People, National Geographic, whatever!”

The next time I went back, there was a whole slew of different magazines. I took it as a small victory. Someone acknowledged that I was still here, still worth paying attention to and treating, even if I would never be one of those blissfully happy pregnant women I had seen in the photos, bathed in light and completely fulfilled by their sheer ability to conceive.

—–

Megan Kamerick is a print reporter in Albuquerque and also does radio work at the local NPR affiliate.

At the outset, the model honored the wishes of families by providing respectful care which enhanced the normal aspects of childbirth. At the same time, it provided through a coherent system of health care the consultation and special medical expertise needed in some cases. It did this through the formation of professional teams which provide the warmth of personalized nurse-midwifery care along with the availability of hospital-based obstetrical care when needed.

Originally, it was middle class women and families who sought out this care, and some 200 centers around the country were established. Today such Centers have proven they are able as well to lower the disparate outcomes suffered particularly by African American families. Because it differs in concept from the practices of conventional in-hospital maternity care, the Freestanding Birth Center concept has had a struggle to be accepted.

What are the outcomes and savings?

Outcome Data and Cost Savings*

After 5 years of operation, FHBC outcome data showed substantial lowering of preterm birth, low birth weight and cesarean section rates compared to those of the District:

(FHBC aggregated data for 2003-2005 were shown to be statistically significant by epidemiology and biostatistics faculty of the School of Public Health of the University of North Carolina.)

Preterm Birth Savings $619,200

Low Birth Weight Savings $277,716

Cesarean Birth Savings $343,882

Total Savings 2005 $1,240,798

Also in 2005, the total Operating Budget of the FHBC was $1,074,014. Therefore, the FHBC saved for the system a figure greater than its own operating budget!

*Sources:

Preterm Birth-Chapter 12 “Societal Costs of Preterm Birth” in Preterm Birth: Causes, Consequences and Prevention, Institute of Medicine 2006

Low Birth Weight-Cost of Illness Handbook Environmental Protection Agency 3/31/06

Cesarean Birth-National cost as reported in the Wall Street Journal (2/21/06)