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States Face Huge Task In Tracking Meningitis-Tainted Drugs
An anonymous reader writes "Confronted with a growing meningitis scare, states are coming under enormous pressure to meet federal requests that they contact more than 1,000 hospitals and clinics that received any injectable drugs from the company at the center of the deadly outbreak."
Get rid of the FDA and let the free market sort this out.
First, I have a relative who received an injection at one of the clinics, and I can speak firsthand to what's going on right now.
This article talks about the tracking problem. Well, it's a problem because nobody knows which batches were infected; The lead time on these things can be weeks or months before there's confirmation of a pathogen. By that time, there's potentially hundreds of infected batches out there. We still don't know (and likely won't for up to a year) which batches tested positive. It could be just a one off -- someone missed a sterilization step in a single batch, and the rest are fine. What's happening right now is an abundance of caution approach. They're recalling everything and testing everyone because we don't know exactly where the problem started and ended.
Also, a lot of patients potentially infected haven't been contacted yet and may never be because of out of date or incorrect contact information. Here, the health department has been tasked with contacting patients -- the clinic hasn't reached out at all. When I heard about this on the news, I called her and we went down to ER and got things sorted (tested negative), but the "Contact the patient" step isn't happening for a lot of people.
And lastly, even when they are contacted, and are tested, some of these patients may have already had the infection cleared due to unrelated treatment. My relative, for example, was put on antibiotics for an unrelated condition not long after the injection, and indicated to the doctors symptoms similar to what they were looking for but they cleared up prior to testing. So that data point is lost: They don't know whether the batch used on that patient was a positive now. And given the low rates of patient return and contacting, that one data point could represent hundreds of patients that need to be put on the priority list for contacting.
By far the biggest problem here is a lack of resources and accurate information. It's not that they're incompetent, or that procedures weren't followed (though both could be true)... but the response has been botched because there just aren't enough people to do the leg work. And don't forget: Whether it's their fault or not, you're still the one being billed. A lot of people don't want to eat their deductible or pay for a hospital visit or testing out of pocket (or copay), unless they know there's a problem. Wouldn't be a problem with nationalized healthcare, but with privatized healthcare "preventative medicine" is practically a swear word.
#fuckbeta #iamslashdot #dicemustdie
Fungal meningitis is rare, largely unstudied, because rare, and of varying severity. One reason for the danger of this outbreak, is that there is no generally accepted course of treatment. As such, we are about to learn things we did not want to know, and under pressure of several thousand potentially exposed patients.
Fugue for Aaron Swartz
I used to work in the Pharma/biotech industry... among other things, I served on teams responsible for all facets of drug sterility (equipment cleaning and sterilization, cleanroom design/operation/cleaning, aseptic filling and personnel aseptic technique). My comments: This is first foremost NECC's fault... prison time may be coming for some folks at NECC. There is the outside chance that this was just a horribly bad stroke of luck, but it is highly atypical to have fungus in your cleanroom one day out of blue and then it suddenly gets into your sterile filling operation; it has to get in through a vector which is way out of tolerance (contamination of sterile water-for-injection system, horribly failed equipment or vial sterilization processes, fungus in the air-handlers for the filling suite, leaks in the HEPA filters, etc. In a proper pharma manufacturing facility, there are almost ridiculous levels and layers of engineering and quality control testing protection to ensure that substandard product can never get on the door (expensive, to be sure... but absolutely worth it!). NECC manufacturing practices were likely horribly sub-par, cutting corners to save money, and if this was the case... some folks at NECC are in big, big trouble BUT... one of the FDA's jobs is to make sure that drug manufacturing facilities are fully capable and have rigorous systems in place to effectively ensure that stuff like this doesn't happen (and it pretty much never should). My experience with FDA in my past Pharma career left me with zero trust of the FDA's ability to fulfill their duty to the public: they understaffed with qualified scientists to scrutinize clinical trial data and investigate and regulate manufacturing facilities. Last, in the case of a severe fungal infection (you or someone you know), ask your doctor about Ambisome (a IV drug for treating severe fungal infections). I'm not a doctor, so that's all I'm going to say lest I give anyone false or misleading information. I happen to know about Ambisome because I used to work for the company that makes it; and I mention Ambisome because I don't think many doctors know about it... at least that used to be the case.
The solution here is for Congress to close the formulation loophole, and for the Agency and the states to work together to create a unified standard of rules.
I always look to people with "the solution" with a bit of skepticism. In this case, I think you're confusing the possibility of a problem with its likelihood.
If Bruce Schneier is to be believed, risk is always a tradeoff. Let's compare the risk of meningitis with the practice of formulation.
Formulation for offlabel purposes and children's doses meets a need, and I would expect that the population benefits are enormous. This meningitis problem is the first one I've heard about in... ever. And the problem is limited to a small number of people because, as people have pointed out, the issue isn't as much the meningitis, it's not knowing how many people may be at risk.
It would seem to me that the risk of problems with formulation is vanishingly low.
If we "close the formulation loophole" as you suggest, that will put all offlabel and children's doses in the hands of the noble and reputable Big Pharma companies. Won't they choose to skip formulations for which there is no substantial market (children's doses, for instance)? Will they not raise prices mercilessly on a captive market?
I dunno... your solution seems formulaic and reflexive. Shouldn't we think through the ramifications first?