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Medicine Government

States Face Huge Task In Tracking Meningitis-Tainted Drugs 99

Posted by timothy
from the call-all-your-former-spinal-tap-partners dept.
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."
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States Face Huge Task In Tracking Meningitis-Tainted Drugs

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  • by girlintraining (1395911) on Sunday October 21, 2012 @04:21PM (#41723955)

    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    Also, a lot of patients potentially infected haven't been contacted yet and may never be because of out of date or incorrect contact information.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.

  • by Anonymous Coward on Sunday October 21, 2012 @04:45PM (#41724085)

    Probably modded down by a republitard who didn't realize that the pharmacy wasn't regulated by the FDA because they were just a mom&pop pharmacy that wasn't supposed to be manufacturing drugs for resale interstate.

  • by girlintraining (1395911) on Sunday October 21, 2012 @04:46PM (#41724087)

    Your post sounded plausible until the last paragraph. Nobody would be billed for getting checked if they received one of these injections. Plus if your relative was given antibiotics the doctor must have had a reason for doing so, a reason as in a lab test that showed that he/she had some kind of an infection. So their record would show what caused the infection.

    Lulz. First, my relative got a bill. I've seen it, it's real. Hell, I got a bill for a rape kit once... I didn't pay. A family who's kid was run over by a police car (officer was 100% at fault) was billed for the repair of the dent to the car. That's an argument you just aren't going to win, man. Second, labs don't always test for the bacteria. Take a bladder infection -- if they see red blood cells, that's confirmation of a bladder infection and they prescribe a generic antibiotic. They may or may not send the urine off for a more detailed analysis, depending on severity of symptoms etc. Not every sample is checked for every thing -- this isn't CSI: Your Healthcare Plan.

  • by Jonah Hex (651948) <hexdotms AT gmail DOT com> on Sunday October 21, 2012 @04:54PM (#41724123) Homepage Journal
    Since the drug companies won't create "children's doses" or other preparations of their profitable drugs this whole "compounding pharmacy" loophole with less FDA oversight blows up into infecting people with meningitis. We need these other preparations, often times they are lifesaving, but we need them with the same oversight given the manufacture of the original drugs. - HEX
  • FDA (Score:4, Interesting)

    by Stirling Newberry (848268) on Sunday October 21, 2012 @05:03PM (#41724171) Homepage Journal
    According to Peter Hutt, accorded the status of "The Dean of Health Law" and the author of the medical devices rules for the FDA, the Agency has lost its way. The criticism that he leveled then is only more appropriate now. Formulation slips into the area between Federal law, which regulates what can be introduced in to interstate commerce, and state law, which regulates the practice of medicine. Because of the narrowness of testing, the FDA approves uses of drugs for specific illnesses and populations, but once approved for what is called "an indication" doctors are free to prescribe it for any use, including those not encompassed by the FDA Label.

    Such "offlabel" use is necessary, because many drugs are approved for narrow populations, but are useful in wider areas. Some 70% of adult oncology prescriptions are off-label, and virtual all childhood prescriptions in cancer treatment. The same is true of formulation, which is supposed the mixture of pharmacological compounds by standard means.

    However, because of cuts to regulation, focus on easier approval soaking up the remaining budget, and fee based payment introduced through the most recent FDA reform, basic enforcement of the mandate of the FDA has decayed drammatical, raising risks as we have seen. Similar problems at the USDA, which has an overlapping mandate in food safety, have seen outbreaks of tainted food.

    In this case there were two violations, one of state medical practice, and one of the Food, Drug and Cosmetics Act as amended. The first is that a formulation should be for a particular patient, with a particular script. The second is that introduction of the formulation into interstate commerce is a violation of the FD&C. Both of these practices have been widely winked at, because of the prevalence of off-label formulation, and because there was too much money being made. Formulators would often corner the market on a particular compound, more or less requiring that it be bought through them, at a mark up.

    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. My co-author and I have proposed also a private right of action by indication holders which would allow the to bring qui tam suits against off-label marketers in overlapping indications, thus giving companies an incentive, namely triple damages, to police companies that use their compounds, or who offer off-label competition.

  • Rarity of infection (Score:5, Interesting)

    by Stirling Newberry (848268) on Sunday October 21, 2012 @05:08PM (#41724203) Homepage Journal
    Meningitis is a description, namely, inflammation of the coverings of nerves or the brain. There are several causes. Bacterial meningitis, which is serious but generally treatable, and viral meningitis, often caused by cocksackie viruses, the same family as the common cold, which is not generally serious, but also not easily treatable, because the body generally prevents movement into the nerve bundle itself large compounds, which most anti-virals are.

    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.

  • by miniMUNCH (662195) on Sunday October 21, 2012 @05:44PM (#41724369)
    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.
  • by girlintraining (1395911) on Sunday October 21, 2012 @11:08PM (#41725767)

    So that sounds quite simple to me. At which stage does the US system differ? The recall list is very long here, but on the other hand, chances are your hospital doesn't use everything on the list and you can completely ignore the ones you haven't stocked.

    I can't speak to every clinic or hospital involved in the recall, but the pain clinic here in the midwest only recorded the batch numbers in their inventory control system. They did not record which patients received doses from which batch. So all they can say is "batch N was used from date X to date Y." Several batches may have been released from inventory at the same time. As well, we have no national recall framework; It is being run at the state level with varying levels of responsiveness and oversight. In fact, it was the compounding pharmacy that initiated the recall, not the government. The federal government did not issue a recall order until almost a week later -- and that recall order then went to the state health departments, who then decided (based on their own policy) how to go about handling the recall.

    In some states, the hospital is responsible for notifying patients. In others, it's the state. While (thankfully) every state has a law or policy to contact the patient, it's actually not required by federal law. If you happened to live in a state that decided recalls weren't important... it would be totally legal for it to simply not happen. :( This is one of the major problems of the United States' "marble cake" government -- each level above pre-empts the level below, but each level below can then interpret the law or impliment it in their own way. And what's worse, funding levels vary by state -- while federal tax dollars are sometimes set aside for enforcement, very often it's left entirely up to the state to fund it. A cash-strapped state may only have 1 guy handling the recall on behalf of the state, and nuts if he's out of town that weekend. Not that this actually happens, but it's an example of what could happen thanks to our marble cake love-in.

    Adding even more confusion to an already hopelessly dysfunctional system... we live with privatized health care right now, and even with ObamaCare, the problem will persist. It's not the manufacturers, clinics, or government's responsibility to pay for the testing and/or treatment resulting from a recall. It's you, the individual, who are responsible. You might well guess what some poor bastard without insurance is gonna do when he hears "Danger! Life-threatening illness. It could be you!" ... Like so many other poor people, poor bastard here is going to ignore it until he's obviously sick. And by law, it was his own damn fault for not coming in, going bankrupt, and living in financial ruin for the rest of his life... our culture and our laws pretty much put the individual in the frying pan as early and often as possible. So if you croak, you deserved it... but only if you live here. In any other part of the world, such thinking would be considered barbaric. Here, we call it Tuesday.

The key elements in human thinking are not numbers but labels of fuzzy sets. -- L. Zadeh

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