Saturday, October 20, 2012

What to regulate?

In the news have been fatal cases of fungal meningitis traced to drugs mixed or packaged at a Framingham MA "compounding pharmacy".  Nineteen people have died, more are ill.  Predictably there have been calls for more "regulation" of "compounding pharmacies". 
   More regulation means more tests, more paperwork, more QC inspectors watching production, more worker training and a big dose of Mickey Mouse.
   But, despite all the hooting and hollering, nobody has yet  figured out what went wrong, and how.  They had been making this stuff for some time and all of a sudden it goes bad.  What really happened?  Did they skip or botch some test for infectious matter?  Fail to sterilize something?  Buy some material from China?  Leave out some important preservative?  Change the formula somehow?  Or what?  I can imagine a lot of ways to let fungus infect your product. 
   Should some investigators figure out the problem and publish a paper explaining how to prevent this dreadful infection, I am 100% positive that every "compounding pharmacy" in the land would immediately make the needed changes to their production lines. 
  We don't need more "regulation".  We need to find out how the fungus got into the product and how to stop it from happening again.

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