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."

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