Pharmacist Barry Cadden, co-owner of the Framingham pharmacy blamed for the deadly national meningitis outbreak, has a long history of not cooperating with federal regulators, including one 2004 inspection when he initially denied having an eye medication that was the subject of a complaint, according to a memo released Monday by a congressional committee.
An inspector later spotted a drawer labeled with the drug’s name, Trypan blue, and asked Cadden to open it. Inside were 189 vials.
Comments
How many people have to die before Cadden is arrested. He's responsible and should serve time for manslaughter. Considering the number of victims, he ought to get life without parole.
Where is law enforcement?
Well, how many is a good question. In Syria the number has reached tens of thousands but that does not seem to have reached the threshhold for action.
I don't see the connection. We don't enforce laws in Syria short of sending in troops.
"...how these companies were able to fall through regulatory cracks and serious violations go unaddressed.”
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I don't think it was somethng passive, the companies were allowed to continue what they were doing in spite of full knowledge by FDA and Mass officials that their license was being violated both by producing and shipping across state lines wholesale amounts of product, and by shipping product whose quality was not validated. Per previous reports the FDA's regulatory authority was clouded by Congress and by the Courts. The state, however, clearly had the authority. So, I would say it's the usualy story in Mass: you chose a "good person" to be in charge and then you don't "annoy" them or get yourself in a sweat by lots of questioning, and monitoring (also called oversight). You can relax and know that they are doing an excellent job because they are a "good person" (and are not subject to ordinary "human nature" mistakes or self-serving action because they know the guilt and punishment that would be heaped on them by "the village". Of course, feckless oversight also allows for intentionally feckless oversight (ie, corruption) -- that's the beauty of it.
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So, go ahead, village, time to heap make an example, heap on the punishment to the "bad person" who caused the problem -- not the oversight board which was just trying to do its job (now would be a good time to mention that the board was all unpaid volunteers, if that is true).
Until there is a well-documented report on the facts of the case, you may be right. But, before then, there is clear need to take steps that prevent this from happening again. The compounding pharmacy failed, in particularly egregious ways, to maintain sterility. Clearly, its head pharmacist bears ultimate responsibility for that: there already seems agreement that this is not a problem limited to one or two people that could easily be missed. However, if inspections previously documented the pharmacy's deficiencies and the state failed to act, the regulatory system failed as badly. Whether you volunteer or are paid to carry out a task, you assume responsibility for carrying it out with enough diligence to guarantee an acceptable outcome. Especially a task that involves patient safety in so fundamental a way.
I read in one newspaper or another that the state only has two pharmacy inspectors and largely depends on pharmacies being honest businesses that submit truthful information. While that may seem naive, the state can't do much better without hiring a lot more inspectors at a significant cost.
This is just the kind of thing that gets ignored because the taxpayers are so resistant to tax increases and its an area that the taxpayers don't normally care much about.
Lest we forget, government is about human beings -- those in government and those who carp from the sidelines.