Want a rotten example? –Robert M. Shelby, 3-11-11. [519 txt wds]

Ref: “The High Cost of Premature Babies”

—(article) By Kevin Drum| in Mother Jones, Wed Mar. 9, 2011


Here’s the worst: U.S. government agency people and executives of a big pharma corporation bedding down with each other to bilk the public in another place where it will hurt vulnerable people, including taxpayers, the most!–Namely, pregnant women who are at risk for premature birth and need medication to stave it off until the fetus is well enough developed to be born safely.


One well-established method of delaying birth is a series of injections with a drug called 17P, a type of progesterone compound discovered in the 1950s and in use regularly since 2003.  Because there has been no commercial, ready-made product available, women’s gynecologists have obtained it each time as needed from what are called “compounding pharmacies.” They make it to order and charge $10 to $15 per shot each week during the particular time-period needed. A full treatment of, say, twenty shots totals $300 dollars which is a feasible cost for most patients.


But, in February this year, the American people’s own FDA (hah!) granted approval of a branded version of 17P to Hologic Inc., under the agency’s “orphan status” rule: “The approval rested largely on a 2003 study financed by the National Institutes of Health, which showed that 17P helped deter pre-term births, and also the fact that doctors had prescribed the drug “off-label” (meaning for a use different than approved by the FDA) to expectant mothers for years.”


Use in premature births was based largely on testing performed in 2003 by a publicly funded agency, the NIH. Still, Hologic was given exclusive marketing rights, which it sold for $200 million to K-V Pharmaceutical, which calls the branded version Makena. As a result:

“KV Pharmaceutical Co. on Monday will start selling a newly FDA-approved prenatal drug — at $1,500 per injection, more than 100 times its current cost… Although 17P has been promoted as a cost saver, KV’s pricing for Makena could actually increase the costs associated with pre-term births and reduce women’s access to the drug. A full treatment of between 15 and 20 shots would typically run $25,000.”


“Wow. That’s a lot,” said Arleasha Hays, a spokeswoman for the Missouri Department of Social Services, which oversees the state Medicaid program and would have to approve Makena’s purchase. “That is very surprising.”


More than surprising, it’s egregiously horrific! Another example of the predatory bipeds’ war on humanity. Kevin Drum concludes his article: “The FDA required Hologic to perform some additional studies before Makena was approved, including a follow-up post-approval study that will run through 2018. Maybe this is worth $200 million. I don’t know. But I wonder if Medicaid will pony up $25,000 for this shiny new version of 17P? I wonder how many low-income mothers will no longer have access to it? I wonder if our pharmaceutical approval system is completely screwed up?”


And I conclude: Can we keep on being mystified about rising health-care costs? Waste is small. Law suit costs are small. Rotten, slimy behavior by white-collar crooks both in and out of government turns our national economy into a pig sty, and that’s huge!

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