Making a difference in maternal mortality

It isn't that childbirth is more inherently dangerous in countries where many women die in childbirth than in those where relatively few die. The women who survive, statistically speaking, are getting appropriate help from trained attendants.

"...The main complications that lead to death during pregnancy or childbirth are fairly common among all women, regardless of where they live," write the authors of an article titled "Are We Making Progress in Maternal Mortality?" in the May 26 issue of the New England Journal of Medicine.Pregnant Graffiti

Hemorrhage, which most often occurs right after birth, is the leading cause of pregnancy-related deaths globally, accounting for 35 percent of all deaths in childbirth, according to the World Health Organization. And in fact, hemorrhage was the second most common complication seen in pregnancies in the United States in 2000.

However, most U.S. women who suffered hemorrhage were treated quickly, and survived, say the article's authors, Anne Paxton and Tessa Wardlaw.

WHO identified the second most common cause of maternal death as hypertensive disorders — pre-eclampsia/eclampsia, for example. Again, these disorders are a common problem all over the world, but women with access to good medical care have a good chance of surviving them.

The countries that are most dangerous for pregnant women are those suffering through wars, or burdened with a large population with HIV/AIDS, the authors write.

In general, poor women die in childbirth more often than affluent ones, rural women more often than urban ones. These populations are more vulnerable because they often deliver their babies without the benefit of skilled birth attendants, and lack access to obstetrical services like surgery by Cesarean section.

Sub-Saharan Africa, with widespread political unrest and HIV/AIDS infection, "has the greatest burden of maternal mortality," even though most countries there are seeing "small but promising" decreases in pregnancy-related deaths.

Worldwide, there is considerable cause for hope, Paxton and Wardlaw write. Maternal mortality has decreased globally by more than one-third since 1990, according to United Nations estimates.

"Dramatic improvements in China and other Asian countries...are associated with economic improvement, decreasing fertility rates and strengthening of health systems...," the authors write.

"The overall rate of decline in global maternal mortality, 2.3 percent, is lower than the 5.5 percent MDG target but is heartening nonetheless," they write.

Image: "Pregnant Graffiti" by Petteri Sulonen


A busy day in the preterm-birth drug drama

A great deal happened today in the amazing unfolding drama of a decades-old drug that has been shown to prevent preterm birth:

* KV Pharmaceutical more than halved the cost of Makena, approved by the FDA in February, which debuted at a price of $1,500 per dose. KV Pharmaceutical dropped the price today to $690, and vowed to make sure clinically eligible pregnant women would be able to afford the drug.

* However, the action wasn't enough to stop the March of Dimes from saying it would "step away from" its relationship with Ther-Rx, a subsidiary of the drug company.

"Access (for women) to 17-P is and always has been our paramount concern," Jennifer Howse, March of Dimes president wrote in a letter today to Greg Divis, president of the Ther-Rx Corp., employing a generic term for the drug, hydroxyprogesterone caproate.

In her letter, Howse acknowledged considerable financial support Ther-Rx has given the March of Dimes.

* Sen. Sherrod Brown (D-Ohio) said he was releasing "previously unreported figures showing the scope of taxpayer investment in the development of preterm pregnancy drugs."

A press release from Sen. Brown's office detailed the $21 million he said went into bringing Makena to market, including these costs:

* An initial trial, showing that the injection prevented preterm births in women who have previously had a preterm birth, cost taxpayers $5 million.

* A second trial, at $1.1 million, showed no side effects in children whose mothers had used the formulation.

* A third trial, costing taxpayers $5.1 million, found that the drug did not work to prevent preterm birth in women carrying twins and triplets; according to the NIH, this study was critical for Makena’s orphan drug status determination because an alternative result could have widened the number of potentially eligible women to use the drug.

* A fourth trial, which is still ongoing, cost $7.5 million through Fiscal Year 2010 and aims to find whether 17P treatments are effective at preventing preterm birth in women with shortened cervixes. This is the largest study of 17P by the National Institutes of Health, and could create another category of women eligible for Makena.

But the cost to the public doesn't end there.

In an article in the New England Journal of Medicine last month, Joanne Armstrong MD laid out the cost of treating the roughly 139,000 women she said were likely to need the drug every year. A course of 20 treatments with 17P at $300, the likely price for the drug compounded by a pharmacist, would cost $41.7 million. A course of treatment with Makena (at the original price of $1,500) for one woman would cost $29,000, or $4 billion for all 139,000, many of whom would need to resort to Medicaid to pay for the drug.

The March of Dimes, as saintly in the public eyes as an organization can be, felt the heat from the public for backing KV Pharmaceutical's push for FDA approval of Makena.

"Only after our threats (to boycott March of Dimes fund-raising events) did the MOD firm up their stance," one man wrote on March 25 on the March of Dimes' Facebook page.

But critics, including the Society for Maternal and Fetal Medicine, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatics, saved their strongest language for KV Pharmaceutical.

Sens. Brown and Amy Klobuchar (D-Minn.) asked the Federal Trade Commission to investigate the drug company for "price gouging at the expense of pregnant women."

Patient safety is not improving: studies

Well, this is discouraging. Two recent studies indicate that, after a decade-long, nationwide campaign to make hospitals safer for patients, essentially no progress has been made.

A patient checking into a hospital today appears to face at least a one-in-four chance of coming to some degree of harm there.

A study published this week in the New England Journal of Medicine looked at the records of 2,341 patients discharged from 10 randomly selected hospitals in North Carolina, which was chosen because of that state's "high level of engagement in efforts to improve patient safety."

The study took place between January 2002 and December 2007. What it found was, in short, that "harm to patients resulting from medical care was common in North Carolina, and the rate of harm did not appear to decrease significantly during a 6-year period ending in December 2007, despite substantial national attention and allocation of resources to improve the safety of care," the report stated.

A total of 588 patients were injured — 25.1 percent of study subjects. Harm was caused by, in declining numbers, procedures, drugs, hospital-based infections, other therapies, tests, falls and other causes, the study found. Sixty-three percent of these injuries were deemed to have been preventable. Nine preventable errors resulted in death, and 13 in permanent damage.

In addition, a report from the U.S. Dept. of Health and Human Services released earlier this month documented the experiences of 780 randomly selected Medicare patients discharged from various hospitals in October of 2008.

About one in seven of these patients experienced "adverse events" — serious harm that comes to a patient as a result of medical care.

A second group of about the same size in the HHS study suffered "temporary harm," a transient injury like bedsores (here called "pressure ulcers") for example, or hypoglycemia. Twenty-seven percent of temporary harm events were caused by drugs.

Twenty-eight percent of patients who experienced more serious "adverse events" also suffered some temporary harm during the same hospital stay.

About 44 percent of all these events — adverse events and temporary harm — in the HHS study were deemed preventable — the result of errors, substandard care, or insufficient monitoring.

In 1999, the independent, not-for-profit Institute of Medicine published a report on hospital safety, "To Err is Human," which caused a sensation and produced a massive effort to improve protocols at hospitals across the country. The goal was to decrease errors by 50 percent over a five-year period.

"To Err is Human" asserted that as many as 98,000 patients die in hospitals each year because of medical error.

Commenting on the two discouraging new studies, the authors of the NEJM report on patient safety in North Carolina write, "All the findings about extent of harm should increase our commitment to prevent it."

Another “monstrous birth” in New England

Allow me one more post on this last day of Women's History Month about Anne Hutchinson, the midwife in the Massachusetts Bay Colony who was banished to Rhode Island for heresy.

The pregnancy Hutchinson had been carrying during her civil and ecclesiastical trials turned out to have been probably the first hydatidiform mole, or molar pregnancy, in New England, according to a 1959 article in the New England Journal of Medicine.Anne Hutchinson

This freakish obstetrical event, which occurs in about 1 in 2,000 pregnancies in the United States today (it is 10 times more common in Asia), happens when a pregnancy goes awry and turns into a mass of tissue in the uterus. The mass might grow for several months, and lumps of tissue might eventually be "delivered." Such a "birth" event would likely be upsetting to anyone, but given the beliefs of the time, it carried a dark judgment on Hutchinson's state of grace.

She was safe in Rhode Island, but the event was sensational news. Imagine the response of her nemesis, Gov. John Winthop of the Massachusetts Bay Colony, when he heard that not only had Hutchinson attended Mary Dyer's "monstrous birth," but now had also delivered one of her own.

I can't stop wondering how Hutchinson felt about this. Although the austere religion practiced in the Massachusetts Bay Colony never allowed anyone to take salvation for granted, according to Calvinism, God's favorite people should be easy to spot: They prospered in this life as well as the next.

Hutchinson herself had had a comfortable life in England, and even in Massachusetts she was a member of the church, the wife of a prosperous textile manufacturer and the mistress of an elegant home right across the road from Gov. Winthrop's, according to Selma R. Williams in Divine Rebel: The Life of Anne Marbury Hutchinson.

Yet her life in America was one catastrophe after another. Hutchinson was a deeply religious woman. Did she feel God's presence so strongly that she was able to dismiss the evidence others saw of His disfavor? Or was she constitutionally unable to listen to people she judged unlikely conduits of the word of God? In any event, she spoke her mind, she stood for what she believed in, and she moved us all forward.