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."

Leapfrog: Early elective births are common

The Leapfrog Group, a 10-year-old hospital monitoring group, has found that doctors and hospitals are commonly scheduling women for elective deliveries before 39 weeks of gestation, even though studies have established a bright arrow that shows that babies are at risk of death or serious health problems if they are born before then.

A survey of 773 hospitals released this week shows that these institutions performed more than 57,000 inductions and Cesarean sections before 39 weeks just in the last year. The hospitals displayed a wide range of rates for early elective deliveries, from less than 5% to more than 40%.

"Leapfrog’s release of 2010 data is the first real evidence that the practice of scheduling newborn deliveries before 39 weeks without a medical reason is common and varied among hospitals even in the same state or community," the report stated.

The brain and lungs aren't fully developed until the very last weeks of pregnancy, said Alan R. Fleischman MD, senior vice president and medical director of the March of Dimes, a group that works to prevent birth defects, and is working with Leapfrog to cut the numbers of early births.

“Women need to protect themselves by refusing to schedule their deliveries before 39 weeks without a sound medical reason, and by knowing the facts about the hospitals they plan to deliver in,” said Leapfrog CEO Leah Binder.

Some hospitals, notably Hospital Corporation of America, have programs in place to encourage doctors to refrain from scheduling Cesarean sections and elective inductions for nonmedical reason, Leapfrog officials said.

The March of Dimes

President Franklin Roosevelt founded the forerunner of the March of Dimes, the National Foundation for Infantile Paralysis, in 1938, to raise money for research to find a cure for poliomyelitis, and to care for victims of the disease.

Roosevelt himself was paralyzed after being stricken by "polio," also called infantile paralysis, in 1921. The NFIP itself was an expansion of Roosevelt's Warm Springs Foundation, which sponsored a rehabilitation center for polio victims in Warm Springs, Ga.March of Dimes poster

In 1938, during a radio fund-raising campaign for the NFIP, the entertainer Eddie Cantor coined the term "The March of Dimes" as he urged listeners to contribute their spare change to defeat polio. The term, as Cantor used it, was a play on the popular newsreel series "The March of Time."

The campaign against polio is one of the great medical success stories. The March of Dimes provided the money for the development of two effective vaccines, by Jonas Salk and Albert Sabin. Within little more than a decade, polio was reduced from one of the scourges of the 20th century to a footnote in the 21st.

A global effort to eradicate polio altogether by the year 2000 fell short; the latest target date for eradication, in parts of Africa and Asia, is 2013.

In 1958, with polio under control in the United States, the March of Dimes re-directed its efforts toward a new campaign, to eliminate birth defects. The following year, Dr. Virginia Apgar, who in 1953 had devised a scoring system for the well being of newborns, joined the organization that was then still headed by President Roosevelt's former law partner, Basil O'Connor.

For the past half-century, the March of Dimes has been involved in virtually every effort undertaken to improve the health of babies in this country and, more recently, around the world.

The March of Dimes supported research that showed that a pregnant woman's consumption of alcohol could cause birth defects, as well as the development of surfactant therapy for premature babies with respiratory distress, to name a couple.

Image from Wikimedia Commons

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.Empire State Building / Purple

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.

Easy to be hard

Birth is the most common reason for a person to be hospitalized in the United States, a major point of intersection for a healthy population with the health-care system.

But while birth may be common, it isn't cheap. The average cost of maternity care in the United States in 2004 was $8,800, according to a report by the March of Dimes, and that figure can take off for the stratosphere — into the tens and even hundreds of thousands of dollars — in the event of complications.Pregnant Graffiti

With the national mid-term elections just a few weeks away, many politicians are drumming up votes by weighing in on the health-care reform legislation Congress passed earlier this year, and on government programs that subsidize health-care services like maternity care for low-income people.

Rand Paul, an ophthamologist who is the Republican candidate for the Senate in Kentucky, remarked last week that half the state's 57,000 yearly births are paid for by Medicaid. “Half of the people in Kentucky are not poor. We’ve made it too easy,” Paul said.

You could say Paul is right. A woman doesn't have to be officially poor in Kentucky to have her baby's birth paid for by Medicaid.  Kentucky allows Medicaid coverage for a woman whose income is 185 percent of the official federal poverty level of $18,310 for a family of three. That is, her family of three can make just under $34,000 and still qualify.

But remember, the average birth experience will cost her almost $9,000.

The March of Dimes analysis found that consumer costs for a birth averaged just under $500, but that pre-supposes that the mother has health insurance that covers childbirth and maternity care.

Analysts for The Guttmacher Institute, which concerns itself with sexual and reproductive health both in the United States and globally, working with recent figures from the U.S. Census Bureau, figure that 2.3 million women of reproductive age lost health insurance in the year between 2008 and 2009 alone.

The National Women's Law Center has found that individual insurance plans, which are exempt from the Pregnancy Discrimination Act of 1978, tend not to offer maternity care. The NWLC found that just 12 percent of the plans it examined offered maternity care, and that the provisions they offered were often limited.

"That’s why having insurance coverage is so critical. Employer-based group plans usually have good maternity care coverage, but most low-income women don’t get insurance through the workplace," the Guttmacher Institute states on its website today.

So looked at from that aspect, Paul is wrong. We're not making things too easy at all. The way thing are set up now, we're making it too hard for women to obtain coverage for maternity care.

Pregnant Graffiti by Petteri Sulonen, courtesy of Wikimedia Commons