Priority medicines for mothers and children

The World Health Organization has published a list of 30 medicines that can make the difference between life and death for mothers and children younger than 5 years of age.

This list of "priority medicines" was developed by the WHO, the United Nations Population Fund and UNICEF. It is the first such list, the sine qua non for mothers and children regardless of where they are , according to an editorial in the Lancet. (This list should not be confused with WHO's Model List of Essential Medicines.)

"An estimated 8.1 million children under the age of five die every year and an estimated 1,000 women — most of them in developing countries — die every day due to complications during pregnancy or childbirth," states the introduction to the list.

The new publication is something of a "wish list," the Lancet notes, in that five of the medicines to protect young children have not yet been developed.

These are the generic treatments on the list that address conditions that threaten the lives of mothers:

* For post-partum hemorrhage — oxytocin and sodium chloride

* For pre-eclampsia and eclampsia — calcium gluconate injection (for treatment of magnesium toxicity), magnesium sulfate

* For puerperal infection —  ampicillin, metronidasole, gentamicin, misoprostol

* For sexually transmitted diseases — azithromycin for chlamydia, cefixime and, for syphillis, benzathine benzylpenicillin

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.