Trimming preterm deliveries

Staying in the womb until 39 weeks of gestation can make a big difference in a baby's life.

Thankfully, that discovery is making its way into the everyday practice of medicine,  according to papers presented at the recent meeting in New Orleans of the American College of Obstetricians and Gynecologists.Pregnant Graffiti

Almost two-thirds of the country's hospitals with a registered labor and delivery unit have put policies in place  to discourage births before 39 weeks, according to a new study conducted by researchers at the Perelman School of Medicine at the University of Pennsylvania.

Researchers contacted all 2,641 U.S. hospitals with LD departments, and heard back from 2,367 of them. Two thirds of responding hospitals have such a policy.

Sixty-nine percent of those reported that they strictly enforced the policy, the study's authors reported. More than half (53%) of the hospitals that do not have a policy in place to discourage births before 39 weeks said "not medically indicated births" before term went against their standard of care.

In March, ACOG reminded physicians and hospitals that babies should not be delivered before 39 weeks gestation without a good medical reason. Serious ealth risks, and even higher mortality rates, have been established for babies born even in the 37th and 38th weeks of gestation.

The results of the Penn study "show that most hospitals do recognize the issues with early elective delivery, or non-medically indicated delivery prior to 39 weeks, and are adopting policies to prevent the practice,” said Nathaniel G. DeNicola, MD, Robert Wood Johnson Clinical Scholar at  Perelman, and lead author on the study.

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."

FDA nixes monopoly on preterm-birth drug

The U.S. Food and Drug Administration on Wednesday took the unusual measure of saying it would allow pharmacists to continue to compound a drug after a new FDA-approved version of the drug debuted in February.

The drug in question is hydroxyprogesterone caproate, which has been around for decades, and has been shown to prevent preterm birth.

The FDA moved to make the drug available in an affordable mode, in light of the fact that the newly approved synthetic progestin, brand-named Makena, produced by KV Pharmaceutical, is going on the market at $1,500 a dose.

When pharmacies compound the "generic" form of the drug, also known as 17P, it typically costs $10 to $20 per dose, according to a press release from the Society for Maternal Fetal Medicine.

In the past, physicians could ask pharmacists to make up a batch of the sterile injectible. However, the FDA ordinarily forbids pharmacy compounding of a drug it has approved.

Indeed, KV Pharmaceutical reportedly sent letters to pharmacies indicating that the FDA would no longer tolerate pharmacy compounding of the drug.

"That is not correct," the FDA declared in its statement.

"In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient" as long as the drug is compounded according to "appropriate standards," the statement said.

Drug companies often charge high prices for newly approved drugs to offset the expense of the typically costly, research-laden approval process.

However, KV Pharmaceutical "received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug's effectiveness," the FDA statement said.

"It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA's accelerated approval program, and received expedited review," the statement said.

More on this tomorrow.

Babies, stay put!

November is Premature Birth Awareness Month at the March of Dimes, part of an effort to bring down the appalling rate of premature birth in this country, where every minute a baby is born before its time — one in every eight babies born — for a total of 543,000 every year. That's almost 1,500 premature babies born every day, 13 of whom die from complications.

Premature birth — any one that takes place before 37 completed weeks of pregnancy — is the leading cause of infant mortality throughout the world. Babies even a few weeks premature can have health problems that will stay with them for their lifetimes.

In the United States, the rate of premature birth has risen 30 percent in the past 30 years. However, after peaking in 2006, the rate has begun to come down. The March of Dimes thinks its campaign, begun in 2003, had a hand in the decrease.

Premature babies can cost 10 times more to care for than babies born after 37 weeks — $32,325, compared with  $3,325 for full-term infants. The total cost of preterm birth in the United States is $26 million, according to the March of Dimes.

The organization hopes to bring premature births down with increased education for moms and health-care providers, prenatal care and research through its Prematurity Research Initiative.

On Wednesday, Nov. 17, the 8th Annual Premature Birth Awareness Day, the Empire State Building in New York will shine purple, the color assigned to this effort by the March of Dimes.

Have preterm births peaked?

Preterm births in the United States went up steadily from 1981 to 2006, but now they seem to be going back down, according to a new report from the National Center for Health Statistics in Hyattsville, Md.

This is the first two-year downturn in nearly three decades, the report states.

The peak year for preterm births was 2006, when they accounted for 12.8 percent of all births. The rate in 2008 was 12.3 percent.

A preterm birth is one that occurs before 37 weeks of gestation. Babies born before this point are more likely to have serious health problems compared with infants born later in pregnancy. Even babies just shy of 37 weeks are more likely to have "neurodevelopmental problems," or to die before they turn one year old, than are babies born at term, the report states.

Preterm rates appear to be falling among women of all age groups younger than 40, among all ethnic groups, in all types of deliveries and in most parts the country. Several states saw a flat rate of preterm births over the last two years, but only Hawaii experienced an increase. The decrease was similar for singleton and multiple births.

However, the report notes that "the U.S. preterm birth rate remains higher than in any year from 1981 to 2002, with large differences still evident by race and Hispanic origin. Further research is necessary to explain the factors behind the current downturn and to develop approaches to help ensure its continued decline."