17P/Progesterone Injections and Gel
Some 12–13 percent of babies (500,000) in the United States and 5–9 percent in Europe are delivered before the thirty-seventh week of pregnancy and classified as premature or preterm. Prematurity is the leading cause of newborn mortality and illness in developed countries. Because their internal organs have not adequately developed, preemies are at greater risk for serious short-term and long-term complications, including cerebral palsy, for which prematurity is the leading single cause. Coupled with the parents’ emotional distress are the medical expenses associated with extended periods of hospitalization, which can amount to many tens of thousands of dollars.
A 2003 federally funded study showed that injections of 17P (17-hydroxprogesterone caproate), given weekly starting no later than the twenty-first week of gestation, reduced the risk of preterm births in women who had had a prior spontaneous preterm birth. Not a new drug, 17P was approved for use in threatened miscarriages in 1956 and marketed and sold as Delalutin until 2000. After the 2003 results appeared, there was renewed interest in 17P, and compounding pharmacists specially prepared it for about $15 per injection or $300 for a full twenty-week course of treatment.
In February 2011, the Food and Drug Administration granted KV Pharmaceutical’s application fast-track approval to exclusively market Makena (17P). This application had the enthusiastic support of numerous health groups, including the March of Dimes, which is dedicated to preventing premature births. Weeks later, the medical community was outraged when KV announced its intention to charge $1,500 per injection or $30,000 for a twenty-week treatment. Within a month, KV buckled slightly under the pressure and reduced its price to $690 per injection or $13,800 for twenty weeks—still almost fifty times more than the usual compounding pharmacist’s price.
In 2011, news of another progesterone product appeared: a vaginal gel that, when applied daily during the second half of pregnancy, reduces premature births by one-half. Women in the study were those with a short cervix, a neck-like structure connecting the uterus and the vagina. The progesterone may act by keeping the cervix closed and the uterus inactive during pregnancy.
SEE ALSO Food and Drug Administration (1906), Progesterone and Progestin (1933), Diethylstilbestrol (1938).
The shorter the pregnancy, the greater the risk of infant morbidity and mortality. At twenty-four weeks, the infant has a 50 percent chance of survival. The premature infant faces multiple organ-system challenges, including problems in the development of the nervous system, cardiovascular complications, and very commonly, ailments affecting the respiratory system.