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Outrageous Price Charged for 17 alpha-hydroxyprogesterone caproate (17OHP): A Blessing in Disguise?

March 30th, 2011 by avatar

A recent New England Journal of Medicine commentator was shocked, shocked, to find that a drug company was price gouging. Joking aside, this is a particularly egregious example of Big Pharma behaving badly. After locking in the right to manufacture 17OHP, K-V Pharmaceutical Company raised the price of treating one pregnant woman at risk for preterm birth by virtue of a prior preterm birth from $300 to more than $29,000, limiting access, according to the commentary, to “the drug’s demonstrated clinical efficiency against a complication for which there are few effective preventive options.”

Why might this be a blessing in disguise? Earlier, I did a blog post, “Does Progesterone Treatment Prevent Preterm Birth? A Case of ‘Skim Milk Masquerades as Cream’”, questioning the effectiveness of progesterone in women with prior preterm birth, including a critique of the trial the commentary cites as demonstrating the effectiveness of intramuscular injections of 17OHP. In that trial, progesterone did not reduce the rate of preterm birth. The rate remained what it had been in similar women before the trial began. Instead, the rate in the control group was much higher than before, and that’s what created the difference between groups. Moreover, the rationale for progesterone is quieting the uterus, but it didn’t do that either. Just as many women in the progesterone group as the placebo group needed treatment for bouts of preterm contractions. Furthermore, another, bigger trial reported no difference in preterm birth rates. So much for “effective.” As I also pointed out in the earlier post, we have no data on the long-term effect of exposing fetuses to weeks of excessive levels of a sex hormone. True, exposure starts after sex organs have developed, but there is more to differentiating boys from girls than looking different, and it is mediated by an ongoing interplay of hormones. The new price barrier could, therefore, protect women and their babies from a treatment that probably doesn’t do them any good and might do their babies harm.

As for lack of preventive options, a social intervention holds great promise. A randomized controlled trial of group prenatal care by midwives (A.K.A. “Centering Pregnancy” ) was published in 2007 in Obstetrics and Gynecology—in other words, hardly buried in an obscure journal. Participants were 1000 women, most of whom were low-income black women, a group at high socioeconomic risk for preterm birth, who were assigned to either group prenatal care or standard care. The preterm birth rate was 14% in the standard care group versus 10% in the group prenatal care group, a one-third risk reduction after controlling for factors that increase risk of adverse perinatal outcomes. In African-American women, the reduction was even more striking: 16% versus 10%. Nothing, nothing anyone ever has tried has reduced preterm birth by a third in a general population.

Why would group prenatal care work? Because preterm delivery is strongly associated with chronic maternal stress. Group prenatal care builds community and helps women feel more competent and confident, as shown by the trial’s other positive outcomes: women in group sessions were less likely to have suboptimal prenatal care, knew more about pregnancy, felt better prepared for labor, were more likely to initiate breastfeeding, and were more satisfied with their prenatal care. With social interventions, everyone wins, not just women spared a preterm birth. Best of all, there is NO downside to group prenatal care, no worries about adverse effects of treatment short- or long-term. As has been said about doula care, another social intervention—which, BTW, is thought to work the same way to reduce cesareans by reducing fear and stress in labor—if group prenatal care were a drug, clinicians would have rushed to obtain it for every hospital pharmacy in the country. And you can bet that providing group prenatal care would cost a lot less than $30,000 per person and probably not even as much as $300, the cost of the cheap version of 17OHP.

Of course it is disappointing that 17OHP isn’t what it’s being cracked up to be. But social interventions have yet to be tried, and at the very least, as the 18th century French surveyor Cassini de Thury said,

 

“It is better to have absolutely no idea where one is than to believe confidently that one is where one is not.”

 

Posted by: Henci Goer

Doula Care, Evidence Based Medicine, Pre-term Birth, Science & Sensibility , , , , , , , , ,