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The cause of preterm labor is still not fully understood. Doctors have identified risk factors such as infections, multi-fetal gestations such as twins and triplets, anatomical abnormalities of the uterus and cervix, smoking, and chronic medical diseases like diabetes and hypertension, all of which have contributed to the rates of preterm delivery.
So this means the treatment of premature delivery is multi-disciplinary, even to this day. There is not a single drug or treatment on the market that is the silver bullet to eradicate preterm delivery.
The specific medication in question – progesterone injections – has been utilized for years as an adjunct to the treatment of premature labor. It is given as a weekly shot and can be used for up to 20 weeks during pregnancy.
Progesterone injections have appeared to make a dent in the premature delivery rates, and that is why so many doctors in obstetrical centers recommend the treatment to their patients.
Previously, progesterone was made in special pharmacies that custom-compound treatments that are not federally approved. However, there were concerns about the quality of unregulated drugs, and as a result, the FDA has given exclusive manufacturing rights to St. Louis company KV Pharmaceutical, who will market the drug as Makena.
But for the government to give the exclusive rights of the drug to a single company who now wants to significantly profit from the manufacturing of this drug is alarming, inappropriate and, frankly, immoral.
I know that one of the rationales that KV Pharmaceutical is giving for the price hike is that the cost of care for a premature baby is estimated to be, on average, $51,000 in the first year alone.
However, this drug is not expensive to manufacturers, as proven by the independent pharmacy services who have been providing this drug for as little as $10 per injection.
So let’s get a grip on reality: if the federal government wants to increase the cost of obstetrical care, they certainly have found a new way to do it. But I would argue if the federal government wants to spend money, I would rather them do it by providing funds for new research on how to treat preterm labor.