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Progesterone Gel Could Reduce The Risk Of Pre-Term Deliveries

Of the 4 million babies born in the U.S. each year, approximately 12.3 percent of them will be premature and 3.56 percent will occur before 34 weeks. Premature birth is one of the leading causes of severe handicaps and has an annual cost of approximately $26 billion dollars. Although risk factors for preterm labor have been identified, there is still no cure. As stated in a previous blog post, when the cervix becomes weak (a condition called cervical insufficiency), the patient is at risk for second trimester miscarriages and preterm labor. Also, if a patient has a previous history of premature birth then she needs her cervix measured in a future pregnancy.  If her cervix is short and measures between 16 mm and 25 mm before 23 weeks, she is at risk for premature labor and delivery. The recommended treatment for a short cervix is either progesterone suppositories or injections. A few months ago, there was profound controversy over an FDA approved injection that would cost approximately $1500.00 if purchased by the manufacturer, K-V Pharmaceuticals. Bending under political pressure, K-V reduced their price to $690.00.

The more options that are available for treatment of premature labor, the greater the chances are of achieving a full term baby. In the past two months, a new study has emerged which describes a progesterone gel that reduced birth rates before 33 weeks by 45 percent and improved newborn outcomes. This is a significant result. Read more »

*This blog post was originally published at Dr. Linda Burke-Galloway*

Kudos To ACOG: A Moral Victory for Pregnant Women

This post is written as a follow-up to The Hijacking of Pregnant Women.

It is said that sometimes you have to rock the boat in order to shift the course of progress. Well today pregnant women have reason to celebrate. The winds of change are apparent.

Bowing under pressure, K-V Pharmaceutical Company reduced the price of Makena from $1500 to $690. Makena is the trade name for hydroxyprogesterone caproate or 17OHP. It is a drug recently approved by the Federal Drug Administration (FDA) to reduce premature deliveries before 37 weeks if it is given before 21 weeks gestation.  It has been used for years as an off-label drug and costs approximately $10 to $20 to make by compound pharmacists. When the FDA gave K-V an exclusive right to manufacture the drug, their integrity flew out the window.  The pricing strategy of K-V is a case study of corporate greed. Most drug companies will use the “research and development” logic to explain their rationale for marking up the cost of a drug.  In the case of Makena, that excuse is valid. The research and development of Makena had already been done by Squibb Pharmaceuticals who had sold the drug for years. Is it any wonder why U.S. citizens will cross geographic borders and purchase drugs from their Canadian and Mexican neighbors?

Kudos are in order to the American College of Obstetricians and Gynecologists (ACOG) who took the lead in questioning K‑V’s pricing strategies. Read more »

*This blog post was originally published at Dr. Linda Burke-Galloway*

Latest Interviews

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Latest Book Reviews

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The Spirit Of The Place: Samuel Shem’s New Book May Depress You

When I was in medical school I read Samuel Shem s House Of God as a right of passage. At the time I found it to be a cynical yet eerily accurate portrayal of the underbelly of academic medicine. I gained comfort from its gallows humor and it made me…

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