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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Also, a lot of patients potentially infected haven't been contacted yet and may never be because of out of date or incorrect contact information.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
I'm going down to my bunker anyway.
This was due to incompetence. Now the scary part is that this could have easily been a terrorist attack... The infrastructure is vulerable and the response is not ready for a major event.
Hold it with the new regulations; Free market will solve this. Substandard companies will be exposed of their incompetency. When people start dropping dead, customers will turn to other suppliers and over time cause the guilty companies to shut down, solving the problem.
See? The free market works!
(I am normally a conservative but this post is sarcastic in nature.)
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
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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.
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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
than the meningitis.
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resist!
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?
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.)
Good reply. Elegantly puts the risk in perspective.
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
If your children ever found out how lame you are, they'd murder you in your sleep
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 industry would
depending upon others is socialism
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
at the stage where an evil socialist liberal dares suggest that the public health is more important than profit making
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
comment to undo bad mod. fucking slashcrap.
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.
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 standing in every lab to make sure things are being ran within the FDA guidelines. There are just as many FDA approved drugs that get pulled off the market or end up in class action lawsuits as the unapproved ones. There should be a body to oversea the drug industry, but the FDA is not it.
http://en.wikipedia.org/wiki/Amphotericin_B
Ambisome is a commercial name.
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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.
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