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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 More

States Face Huge Task In Tracking Meningitis-Tainted Drugs

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  • Get rid of the FDA (Score:5, Funny)

    by Anonymous Coward on Sunday October 21, 2012 @04:05PM (#41723889)
    Get rid of the FDA and let the free market sort this out.

    • Re:Get rid of the FDA (Score:4, Funny)

      by game kid ( 805301 ) on Sunday October 21, 2012 @04:10PM (#41723913) Homepage

      While we're at it, let's bulldoze those damn hippie free clinics and replace them with good-paying private hospitals.

      Then we'll have what it takes to Create Jobs(tm)!

    • No, it must be China's fault for making such shit products.

    • You're joking, but I'm always amazed when conservatives want to deregulate the government and leave us at the hands of big business. They believe that government is bad, and that the free market should be allowed to work without interference. Look at how that's working out for China. Massive water pollution, schools collapsing during earthquakes due to lax building codes, air that is not breathable, kids working ridiculous hours for puny wages, ubiquitous counterfeiting of foods and medications, and lots of

      • The "Peoples' Republic of China" has free markets? (Score:4, Insightful)

        by TarPitt ( 217247 ) on Sunday October 21, 2012 @11:09PM (#41725775)

        Only if your meaning of free is "free of independent trade unions", "free of civil tort damages", and "free of not-completely corrupted regulatory agencies"

        The conservative agenda in the US is freedom only in the sense that you have the freedom to do as you wish with your slaves

      • Re: (Score:1)

        by MLBs ( 2637825 )

        You're joking, but I'm always amazed when conservatives want to deregulate the government and leave us at the hands of big business. They believe that government is bad, and that the free market should be allowed to work without interference. Look at how that's working out for China. Massive water pollution, schools collapsing during earthquakes due to lax building codes, air that is not breathable, kids working ridiculous hours for puny wages, ubiquitous counterfeiting of foods and medications, and lots of other bizarre shit that just make you wonder if the free market without government regulation wouldn't simply be anarchy.

        You're only listing how it affects the people, and ignoring the fact that conservatives are working for corporations. I'm sure corporations in China are prospering.

        The first rule in optimization is knowing which variable you're optimizing.

      • Re: (Score:2)

        by tlhIngan ( 30335 )

        You're joking, but I'm always amazed when conservatives want to deregulate the government and leave us at the hands of big business. They believe that government is bad, and that the free market should be allowed to work without interference. Look at how that's working out for China. Massive water pollution, schools collapsing during earthquakes due to lax building codes, air that is not breathable, kids working ridiculous hours for puny wages, ubiquitous counterfeiting of foods and medications, and lots of

        • Re: (Score:2)

          by HiThere ( 15173 )

          I would have said "even nominally philanthropic corporations". With that slight change I agree with you.

          But I've heard too many stories of deals where "gifts" from the Bill and Melinda Gates foundation were closely associated in time with contracts with Microsoft to actually consider them very philanthropic. This isn't to deny that they've done some good things, but when someone does good things for pay you don't normally call it philanthropic. (In this case I think I'd call it a tax avoidance scheme.)

    • if you have an injection that murders you, the next time you get an injection you will choose a different supplier

      and even if you just get very sick, you will be sure to be an informed consumer and do your research on murky supply chains for medical injections, before it happens again

      these damn liberals and their regulations just want to destroy the market with their nanny state ideology

      the consumer can take care of himself

      in fact: you should be doing your own injections, like a self-sufficient captain of i

  • Scope of the outbreak (Score:5, Interesting)

    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.

    • Re: (Score:2)

      by Velex ( 120469 )

      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.

      There's one other alternative: make medicine work like any other for-profit service. If I get meningitis from a hospital stay, the HOSPITAL eats the cost like any other business.

      You know, come to think of it just because I have circumcision on the brain lately, that would be perfect. Make hospitals eat the costs when something goes wrong. I'll bet you'd see a whole lot more effort go into making sure things don't go wrong. The way it works in our system is the American Academy of Pediatrics says "hey

      • Re: (Score:2)

        by tomhath ( 637240 )

        If I get meningitis from a hospital stay, the HOSPITAL eats the cost like any other business.

        That's called an Accountable Care Organization and outcomes based reimbursement. The US is already going there.

        • Re: (Score:2)

          by HiThere ( 15173 )

          Maybe. It's not at all clear in my mind that this is actually what's happening.

          Yes, I've heard that hospitals must eat the expense if the patient is readmitted quickly, but what that seems to be doing is causing lots of patients who should be admitted, to be classified as "under observation" for a short while and then kicked out. So it doesn't risk the hospital being charged for an admittance that *THE INSURER* deems unwise. This is not good at all.

    • The latest outbreak is of fungal meningitis, which is not contagious but also cannot be treated by regular antibiotics. Luckily, your relative was very likely not a victim of the outbreak because the course of antibiotics she was on would have done nothing to stop the fungus from running wild in her system.

  • 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

    • My mother frequently uses a compounding pharmacy. The reason is twofold. First, she had an ongoing condition involving healing after surgery, that turned out to be heavily dependent on getting her blood thinned enough that it transported antibiotics properly into bony tissue with poor veinous access. It took a while to get a proper diagnosis on this, but by the time she did, she had found some good doctors, who very regularly monitored her blood viscosity while the treatments that finally cured the conditio

      • Re: (Score:2)

        by Rich0 ( 548339 )

        There's a need for good compounding pharmacies, and it's a pity that there doesn't seem to be national resolve to regulate them in precisely the same way as other pharmacies or businesses that manufacture stock drugs.

        The reason that they're not regulated in the same way is that they probably wouldn't exist if they were. The testing quality controls required for the manufacture of even generic drugs are fairly expensive, and they're recouped because of the economies of scale. If the money was there to be made, you wouldn't need a compounding pharmacy in the first place.

        The problem isn't from the existence of compounding pharmacies, but rather that a practice designed to regulate small regional companies making botique

    • Since the drug companies won't create "children's doses" or other preparations of their profitable drugs

      One of the most profitable drugs would be viagra. I see no need for childrens doses.

  • 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.

    • Babies and bathwater? (Score:5, Insightful)

      by Okian Warrior ( 537106 ) on Sunday October 21, 2012 @05:46PM (#41724377) Homepage Journal

      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?

      • I dunno, you don't seem to know the first thing about what you are talking about. Perhaps you know the different risk rates between specific formulation adverse drug events and general formulation adverse drug events?

        • I dunno, you don't seem to know the first thing about what you are talking about. Perhaps you know the different risk rates between specific formulation adverse drug events and general formulation adverse drug events?

          You raise a good point. How do we sort through techno-babble and hand-waving by experts?

          Experts frequently get caught up in their own world and view everything as through blinders. I'm sure your view makes perfect sense to you and you don't see any problems locally.

          Here's a question for you: Another poster pointed out that formulation is the only way to get child-sized doses of certain drugs - the drug companies simply don't want to produce child-sized portions because the market is too small.

          Your solution

          • Your post is pervasively dishonest. First, you clearly don't even know what the formulation loophole is. It isn't, as you falsely assert, about creating particular dosages for particular patients with particular prescriptions. That is a matter for state regulation of the practice of medicine, and while some harm can be done, it is a one off question of standard of care.

            But as anyone with a modicum of honesty can tell, which is not you – you, not I, are shilling for an industry – this isn't wha

          • >You raise a good point. How do we sort through techno-babble and hand-waving by experts?

            Ask yourself the simple question: would you want something injected into your nervous system directly that had been left out over night with an open container?

          • Re: (Score:2)

            by HiThere ( 15173 )

            I doubt that he works for a drug company. This doesn't mean he's well informed, but you don't seem to be either (nor am I).

            One thing that I do know is that children of different ages metabolize drugs significantly differently. So adjusting the dose of a drug proportional to the weight of a child, when it's figured for an adult, and result in EITHER overdosing or underdosing. Depending on the age of the child. This may not be true for all drugs, but it certainly is for many. As I understand it, doctors

      • Re: (Score:2)

        by Rich0 ( 548339 )

        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?

        Well, if you're going to make a special formulation for three patients per year, SOMEBODY has to pay for it.

        Right now it is cheap because somebody just goes into a lab, mixes some stuff up, and mails it off with a note saying that they were careful.

        If that were done under the process used for large scale drug manufacture, then what would happen is:
        1. Somebody figures out how to mix it all up (not much harder than what was done here), but would document the living daylights out of the process.
        2. Somebody f

    • Seriously? There have been what, 23 deaths so far? Out of a population of over 300 million people that is nothing. It is horrible and tragic for those directly involved but this hardly calls for the kind of FUD that is being spread and the amount of fixes and reform that is being suggested. I'm not saying we shouldn't try to improve the system, we obviously should. What I am saying is we shouldn't bend over backwards and place excessive regulatory and inspection burdens on pharmacies that followed the

      • Good reply. Elegantly puts the risk in perspective.

      • Seriously? There have been what, 23 deaths so far? Out of a population of over 300 million people that is nothing.

        Here's a helpful statistical hint for you. Only a very small subset of that 300 million got the injections.

        If all 300 million people got injections and only 23 died, then you would have a point. But they didn't, so STFU, you're talking out your ass.

        • Woosh doesn't even begin to describe your complete lack of understanding. The point is, we don't need to reform our regulatory process, write new laws, and get into a national frenzy over something that caused 23 deaths and is already a violation of our current laws/regulations. 23 / 300,000,000 means that it isn't of significance to the country as a whole. How many people got the injection is irrelevant to this point.

          It's like national news reporting a child who has been kidnapped. It is terrible an

  • 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.

    • coxsackie

      named after coxsackie, ny, where a correctional facility provided the medical sample that the virus was first identified in

      http://en.wikipedia.org/wiki/Coxsackie,_New_York [wikipedia.org]

      it's actually a nice little hudson river town. but i don't think the virus does much for their tourism rates

      then again, lyme, connecticut is a delightful town on the connecticut river

      maybe quaint northeastern us river towns are doomed to have diseases named after them

  • The FDA blew it, among others (Score:4, Interesting)

    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.

    • Re:The FDA blew it, among others (Score:5, Informative)

      by PPH ( 736903 ) on Sunday October 21, 2012 @07:23PM (#41724807)
      Compounding pharmacies [wikipedia.org] are regulated by the states, not the FDA the way drug manufacturers are.
      • So... that explains a lot. My opinion of the FDA still stands (discussion for another time)... but I was trying to imagine how the FDA could screw up so royally. Well, they didn't... complete oversight on my part. This then begs some additional questions: "How are compounding pharmacies regulated and why are they allowed to sell cross state without being inspected/regulated by the FDA?" I can't help but also ask, "why are non-FDA regulated facilities allowed to produce injectables?" They are numerous F

    • Ambisome is a brand of Amphotericin B, which has been around as a generic since the 1960's, and, like Fungisome, is in a liposomal formulation to improve its IV tolerability. Most doctors know the generics well, and generally do not keep track of old generics by their current brand names.

      • It is actually more than just a brand of Amphotericin-B. *Again, I'm not a medical doctor... just providing info & opinions* Standard Amphotericin-B is nick-named 'Ampho-terrible' because of its nasty side effects (high liver and kidney toxicity in acute doses); upon injection / IV adminstration, Ampho-B is filtered out of blood stream rather quickly and so the efficacy of the drug is lowered and it's adverse effects against filtering organs of the body increased. In Ambisome, Ampho-B is encapsulated
    • http://en.wikipedia.org/wiki/Amphotericin_B [wikipedia.org]

      Ambisome is a commercial name.

  • Recalls aren't that complicated... (Score:3, Informative)

    by dandelionblue ( 2757475 ) on Sunday October 21, 2012 @06:17PM (#41724523)

    So, I work in a hospital pharmacy in England. If we were in this situation:

    1. The drug company would be required by law to notify the Medicines and Healthcare Regulatory Agency (MHRA) upon realising there is a problem. This can be done out of office hours if it is a serious problem (we have class 4 recalls for things like typos in leaflets, which tend not to qualify for urgent action).

    2. The MHRA would fax out a drug recall notification to all hospital pharmacies, private hospital pharmacies and Primary Care Trusts in the country, who would be responsible for forwarding it to any community pharmacies, doctors and dentists in their area (assuming this was a drug those groups would be likely to have - this won't happen if the drug is hospital-only). Many pharmacists are also signed up for instant email notifications of drug recalls. The MHRA doesn't waste time working out which hospitals have been affected - it's the hospital's responsibility to determine whether they stock(ed) that drug using the brand names, manufacturers and batch numbers given.

    3. In the case of direct harm to patients, this would be a Class 1 Recall ("potentially serious or life-threatening") requiring removal of the product from hospitals/pharmacies/doctors etc immediately. If you are the on-call pharmacist for a hospital and it's 6pm on a Sunday, tough, you'd need to go in and sort it out there and then - quarantine the drugs, take them out of ward stock, etc.
    3a. In this case, the original recall has been expanded to include things that only might be problematic, so those could be done as a class 2 recall (action within 48h, not immediate) or even class 3, so hospitals can concentrate on the stuff that's actually killing people.

    4. The hospital is also required to contact all potentially affected patients (we don't usually record batch numbers for which drugs have been given to patients except in certain specific cases, so we would usually need to contact all patients who received Drug X within an appropriate timescale).

    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.

    (Don't just say "it's because the US has 300m people and you have 60m"; that just means your regulatory agency needs to send out more faxes initially and I'm sure the faxes are done via some sort of batch method.)

    • I like that you guys seem to have a sound plan for dealing with this, though I wonder why they use a hierarchy for disseminating information to smaller and small scale pharmacies. Wouldn't it make more sense that all pharmacies should be notified by one central body both for expediency and for reducing the margin of error that one of the links in the chain might goof?

      • I like that you guys seem to have a sound plan for dealing with this, though I wonder why they use a hierarchy for disseminating information to smaller and small scale pharmacies. Wouldn't it make more sense that all pharmacies should be notified by one central body both for expediency and for reducing the margin of error that one of the links in the chain might goof?

        I suspect the reason is actually fairly simple. In the case of a major recall, speed of confirmed communication is paramount. Hierarchy means that one organization isn't simply trying to contact everybody for personal handoff, but is instead multiplying its capacity by creating a cascade effect. If every pharmacy in the country was centrally registered with emergency contact details, this procedure could probably be done away with, but protocols take a long time to change, even when they're no longer valuab

        • Yep, it's a bit of both. There are two registers of pharmacies:
          - a national one, run by our regulatory body, which includes both hospitals and community pharmacies
          - more local ones, held by the PCTs

          You could get the national listing involved but it adds a layer of bureaucracy (the organisation that holds all that data has many other functions which might interfere with speed of recall). So you talk to the PCTs instead, who know exactly whom they're paying locally and don't have as many people to contact. Ad

      • I think it's because the hospital system and the community pharmacy system are very separate, and while both are regulated by a central body (the General Pharmaceutical Council) that body has no involvement in drug recall cases, because it doesn't regulate drug standards, only pharmacists and pharmacy premises. So you can either: be the MHRA and directly contact all hospitals plus all PCTs (who will do the legwork of then contacting primary care doctors/dentists/community pharmacists), or be the MHRA and co

    • Re:Recalls aren't that complicated... (Score:4, Interesting)

      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.

    • at the stage where an evil socialist liberal dares suggest that the public health is more important than profit making

    • Re: (Score:2)

      by tazan ( 652775 )
      I think the main difference is it wasn't a drug company involved, it was technically a pharmacy that botched it. So it's traveling down an entirely different path.

      • Well, we don't have something called compounding pharmacies here as such, so I think they'd be considered a "specials manufacturer" - premises licensed for the production of unlicensed medications, usually things like syrup versions of tablets or unusual mixtures. But specials manufacturers are still required to notify the MHRA and get a recall cascade going, just like a "proper" manufacturer.

  • This was probably already talked about or slashdot readers, read the original linked article, but this is not a "outbreak" situation. Only the people who received the steroids are affected. Not only that but it is believed that other drug companies steroids are also tainted. It was thought only one company was to blame. The FDA is to also blame for this, and why people continue to stand up for this group is mind boggling. They do not oversea a damn thing they require reports, they do not have agents standin

    • In case you missed the other Score 5 posts...the FDA has no jurisdiction over compounding pharmacies like the one in Massachusetts. Such pharmacies are under state regulation, not federal.

      Also, while we're on the topic of the FDA...don't forget the House Republicans' budget cut FDA funding by $285 million. Kinda hard to have "agents standing in every lab" when you don't have enough money to pay said agents...

  • Has anyone put up a list of potential suspect clinics anywhere?

    My mother received an epidural steroid injection shot, methylprednisolone, about a year ago. While I'm reasonably certain there are no complications (certainly they would have shown up by now), I would feel much more comfortable if I could verify that the clinic which treated my mother was not one that received any drugs from this compounding pharmacy.

    • Re: (Score:2)

      by Rich0 ( 548339 )

      No idea where the list can be found, but I'd think that something like a prednisone shot would be available from traditional manufacturers.

      Not that this necessarily means anything. Several trade magazines have blasted the practice of doctors obtaining things from compounding pharmacies that are otherwise available from conventional manufacturers. I can completely understand the need for alternate sources for unusual medications that otherwise would never be made, but there is really no excuse for using th

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