Saturday, May 21, 2011

This is not a leak. This is public info about FDA approval of a perinatal drug.

from the movie Babies
This is not a leak.  This is public information, posted at First a bit of background on Pub Med, then the nonleak itself (about a drug the FDA approved).

Pub Med is the online, open-access archive of all articles published in medical journals. While the full article may not be available for free online, the abstract is (not all articles in the New York Times or many literary journals are for free, either). The full article is in the specific journal, and all relevant information needed to hunt that down is in the link. For your edification the number at the end of the link is specific.

Every article published in medical journals is assigned a number and can be researched by inputting the number, in this case 21471853, into Pub Med. I do a bit of related research (is how I know this).

Now for "Unjustified Increase in Cost of Care Resulting From U.S. Food and Drug Administration Approval of Makena (17α-Hydroxyprogesterone Caproate)."

Six physician/researchers from, variously the Albert Einstein Medical Center; the Yale University School of Medicine; the Washington University School of Medicine; the University of North Carolina School of Medicine; Massachusetts General Hospital; and the University of Texas Medical Branch, Galveston co-wrote the article.

The plot is simple and time-tested. A drug company (Big Pharm twirling its shellacked mustachio) and the FDA (a few select officials made all the happier) got together.

I am in no position to say if there was malfeasance or simple neglect. Also I am taking the researchers' words to be true--something I can't verify. That said, I have never seen an article like this.

The drug is Makena. It is manufactured by KV Pharm. Its use run $30,000 per pregnancy (for preterm deliveries; those costs are prohibitive to many. BUT there are alternatives to its use. Good, scientific, medically sound low-cost 9or far lower cost) medicines for preterm deliveries / perinatal care.

Makena's approval ENDANGERS lives. "This increased health care cost is not justified at this time."

And further, the team maintains:
The price barrier to access imposed by KV Pharmaceutical actually could result in an increase in preterm deliveries over current rates. Actions are needed by the FDA, national societies, and the manufacturer to ensure that all high-risk patients continue to get the needed therapy to reduce the number of preterm births.
So I am doing my little bit to get the information out there, to you and whoever you pass it onto. Pro-lifers, by which I mean vigilant anti-abortion groups, should take up the cause. Right?

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