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99 comments

Get rid of the FDA (5, Funny)

Anonymous Coward | about a year and a half ago | (#41723889)

Get rid of the FDA and let the free market sort this out.

Re:Get rid of the FDA (3, Funny)

game kid (805301) | about a year and a half ago | (#41723913)

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)!

Re:Get rid of the FDA (1)

davester666 (731373) | about a year and a half ago | (#41726489)

Or at the very least, eliminate the unemployed.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41731521)

Or at the very least, eliminate the unemployed.

But who's going to pay for all of those bullets?

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41723963)

Modded down for irony?

Re:Get rid of the FDA (4, Interesting)

Anonymous Coward | about a year and a half ago | (#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.

Re:Get rid of the FDA (0, Insightful)

Anonymous Coward | about a year and a half ago | (#41724217)

Wrong. It wasn't regulated by the FDA because the FDA explicitly doesn't have the authority to do so. While the FDA has no authority to regulate the company, that doesn't mean they weren't under strict regulations and weren't being monitored to prevent events like this from happening. In fact, they were: by the state the compounding company was located in. In this case, Massachusetts. Yet again, a failure of Massachusetts to properly regulate businesses in their own state exports death to the rest of the nation, although they'll be hard pressed to beat 9/11 for "most death exported due to state incompetence."

I'm not sure why people are singling out the FDA or compounding company when the actual organization responsible for ensuring that the medication was safe was the state of Massachusetts itself. They took on that responsibility through regulation, they should OWN that responsibility. But, no, they're blaming the company itself and the FDA rather than their own incompetence in not realizing what the company was doing.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41724321)

They took on that responsibility through regulation, they should OWN that responsibility

So Wisconsin should be responsible for those people that got shot today [google.com] ? After all, they "took on that responsibility" through regulating murder.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41724387)

Yes.

It is never accurate to put 100% of the blame for an event on one single cause. Everybody who has some influence on an event shares part of the blame if it goes wrong. How much control you have determines the portion of the blame.

Re:Get rid of the FDA (4)

sjames (1099) | about a year and a half ago | (#41724951)

The first stop for blame IS the pharmacy. They exceeded their license and used sloppy procedure resulting in many serious illnesses and several deaths. That's probably why the pharmacy was singled out, they caused this.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41724545)

Wow.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41725737)

Yeah, wow

I got a series of three injections not long ago and am scared.

Guess I am just a statistic to some here.

Re:Get rid of the FDA (2)

darkmeridian (119044) | about a year and a half ago | (#41725271)

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.

Re:Get rid of the FDA (0)

Anonymous Coward | about a year and a half ago | (#41725289)

LOL, the problem in China is not lack of government, of which they have plenty, it's corruption in the government.

The "Peoples' Republic of China" has free markets? (3, Insightful)

TarPitt (217247) | about a year and a half ago | (#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:Get rid of the FDA (1)

MLBs (2637825) | about a year and a half ago | (#41726335)

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:Get rid of the FDA (1)

tlhIngan (30335) | about a year and a half ago | (#41729529)

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 looking at it from a social equality perspective. Look at it from the other side - you have lots of money (and thus, power), connections with people equally powerful, and basically have it all. "Everyone else" now looks like a money-grubbing leech who wants to take your money (and power) away from you. Or enact laws restricting what you can do, further limiting your ROI and money making prospects.

So naturally you're opposed to big government (taxes - stealing your money!, legislation - stealing from your income and power with environmental/labour/etc laws, etc). You're opposed to anything that requires you to give up money (minimum wage laws), etc. Oh yeah, and to suppress dissent to prevent an uprising (ever wonder why they cracked down so quickly on Occupy?).

Hell, even philantropic companies like the Bill and Melinda Gates Foundation have agendas.

It doesn't help that most politicians are also very far removed from "average joe" life - being able to own a house (or multiple), acres of land, salaries that are still a fairly big multiple of the average salary, pension plans unmatched by anyone else, etc).

Re:Get rid of the FDA (1)

HiThere (15173) | about a year and a half ago | (#41729791)

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.)

clearly (1)

circletimessquare (444983) | about a year and a half ago | (#41725777)

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

Scope of the outbreak (5, Interesting)

girlintraining (1395911) | about a year and a half ago | (#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:Scope of the outbreak (-1)

Anonymous Coward | about a year and a half ago | (#41724007)

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.

Re:Scope of the outbreak (5, Interesting)

girlintraining (1395911) | about a year and a half ago | (#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.

Re:Scope of the outbreak (1)

tomhath (637240) | about a year and a half ago | (#41724243)

There's no such thing as a "generic antibiotic". Bacteria or yeast? Gram positive or gram negative bacteria? It all makes a big difference in what specific antibiotic is prescribed.

Re:Scope of the outbreak (1)

Guppy (12314) | about a year and a half ago | (#41724435)

There's no such thing as a "generic antibiotic"

Sure there is. For instance, the UTI drug Methenamine -- it operates via a very non-specific mechanism of action, and thus is equally in-effective against everything :P

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724749)

it operates via a very non-specific mechanism of action, and thus is equally in-effective against everything

That's an antibacterial, it does indeed have a very specific mechanism and it wouldn't have any effect on the fungus that causes the subject meningitis. And it would probably make a yeast infection worse.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41728001)

You have no idea what you're talking about.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724585)

when was the last time you went to a doctor? These modern pharma-educated quacks are glorified drug pushers.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41726887)

It depends what you mean by generic, I found I was pissing blood clots, and was given an antibiotic this cleared the symptoms for a while but the bacteria were resistant to that antibiotic and regrouped, which were then treated by a second antibiotic which seemed to work then i got a third batch this time i had blood red sperm and my right testicle blew up like a golf ball and I got a prostate exam. Third antibiotic treatment.

A few months pass by with no symptoms and I get to see a consultant and ultra sounded twice urine flow checked, balls fondled another prostate exam. An Xray dye used for my kidneys (with the possibility of kidney failure within 48 hours) had to drop one of my regular medications metformin as it could kill me. Rounded off by the insertion of a relatively huge endoscope into my bladder yes through the japs eye (seriously it was biro sized and i didn't think it would have fit i asked if there was some thinner attachment to go on the end but no it really was that big anaesthetic gel made it painless although there was a lot of pressure and a strong urge to pee) and i got to see the inside of my bladder looks like white fat with lots of small veins. The end result nothing wrong other than a small cyst on my left kidney.

I think that is supposed to be harmless...

Re:Scope of the outbreak (1)

Rich0 (548339) | about a year and a half ago | (#41731677)

Uh, the last time I got an antibiotic it was prescribe first and wait for the test results to come in later. The alternative is to just let the infection grow until they figure out what works.

Usually they take their best guess, and if in a few days it turns out they're wrong they change approach.

At least, that has been my experience with every doctor I've worked with.

Re:Scope of the outbreak (1)

Guppy (12314) | about a year and a half ago | (#41724397)

Hell, I got a bill for a rape kit once... I didn't pay.

Not sure I understand this correctly, if you were billed for something you didn't use, or billed for something you feel you shouldn't have to pay for. Anyway though, if you're getting medical bills for random items out of the blue that you didn't receive, it is possible some uninsured person is using your SSI or contact information to obtain care. Better check to make sure weird things aren't going into your medical/credit record.

Take a bladder infection -- if they see red blood cells, that's confirmation of a bladder infection and they prescribe a generic antibiotic.

Suggestive of a bladder infection, but RBC contamination is frequent in menstruating females. Viral infections of the bladder can also cause it, especially adenovirus.

Re:Scope of the outbreak (1)

flimflammer (956759) | about a year and a half ago | (#41724659)

They never said they didn't use it. They said they didn't pay for it. Your second thought mirrors the rest of their examples, that it's something you shouldn't need to pay for when something is done to you out of your control, like the kid getting hit by a cop car and the mother being billed for the car damages.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724663)

if you were billed for something you didn't use, or billed for something you feel you shouldn't have to pay for.

Sounds like she was billed for an emergency room visit. The hospital has to bill it to the patient first, then they can request reimbursement from CMS when the patient ignores the ER bill.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41726719)

I believe that you are deliberately acting daft. The notion that your healthcare is some omniscient perfect entity is particularly absurd given the topic of discussion. No, for any random infection or preemptive use of antibiotics the doc does not test you for everything. Testing takes time. Infection is much easier to combat when treated immediately.

In the real world you are billed in all sorts of ridiculous situations. The billing is routine even when ridiculous. Billing after payment has been sent and processed through the bank. Billing in work related accidents where the employer and employee both get the same bills. Billing in the healthcare system requires no fraudulent person stealing your identity. The healthcare system in the US is fraudulent on its own as a matter of routine. You must live a sheltered life not to have experienced this. More likely you are just playing dumb to troll and drag down the discussion.

Re:Scope of the outbreak (0)

khallow (566160) | about a year and a half ago | (#41725877)

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.

My suspension of disbelief is broken. Please pay $100.

Re:Scope of the outbreak (1)

DeadCatX2 (950953) | about a year and a half ago | (#41728551)

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.

First, my relative got a bill. I've seen it, it's real.

Many health insurance plans will not pay for emergency room visits if the patient is not admitted. Without further details, I'd say your relative was billed for the unnecessary ER visit.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724241)

Nobody would be billed for getting checked if they received one of these injections

The CDC may not be billing for the CSF test, but nobody's going to tap your spine to get that CSF for free. You're welcome to sue NECC to collect the cost though, just stand in line with everyone else suing them for millions of dollars.

Plus if your relative was given antibiotics the doctor must have had a reason for doing so

Ahahah, that's a good one! My previous doctor prescribed antibiotics (Levaquin) because my white blood cell count was high. Sure, I was running a fever and he had a lab test that showed I had "some kind of an infection" (or, if you believe House, cancer. Or Lupus.) but he didn't even know if it was bacterial. Few docs do bacterial cultures to find out what you've got anymore, much less antibiotic susceptibility tests to tell you what you ought to take to get rid of it. Last time I had a bacterial culture was when I was in high school and had a hemolyzing staph infection that pretty much ate the entire dish of blood agar. The doctor seemed pretty impressed.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41727769)

You don't know people, medicine or testing from a doctors point of view, or the law according to hipa. The patient has a sore muscle, and a headache, do you keep the sample of a blood draw for more then a year. No responsible agency keeps a sample past the next test. they read the test needed, and destroy the sample.Unless you recognize the name on the sample, are working for the UN, or some other BS. Profit demands, fastest possible results. Not storage of samples till the cows come home. Think man in a business program style.
The biotics were probabley given as a pallative to ease the concers of others. Mom's not feeling right now, youtake her to the dr's because of swelling of leg, shes older then you, possible infection from cat scratch, dog flea bite, whatever, biotic. 13 days worth. cures what ever ailed her. but should not have fully cured her, takes a minimum of 14 days, up to 20 days, why is there drug resistance developing in peoples in the insured world. you proved you are susuptible, to a disease, lets kill you earlier from it now.
Oh, and billing, everyone pays for the least testing done. if not the patient, the clinic, if not the clinic, who, but someone pays for the test.So don't bs us.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724049)

Antibiotics don't do diddly to a fungus. The anti-fungal treatments mentioned in the article would clean up this fungus if administered early, but the chances that you inadvertently contracted some other fungal disease, got it treated and only THEN found out you had a potentially contaminated epidural are pretty slim.

Re:Scope of the outbreak (1)

bbelt16ag (744938) | about a year and a half ago | (#41724081)

no wonder... i never knew it was a fungi... i love fun guys.... wait... not fun...

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724089)

I am beginning to wonder you are same as Khyber, you both have a tendency to be pathological liars. You both tests the limits of what could be believed. Are you both conducting an experiment on slashdotters or something?

Re:Scope of the outbreak (1)

Velex (120469) | about a year and a half ago | (#41724137)

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, free money" and removes a foreskin. Then later on when something goes wrong the urologist says, "Well, buddy, that kinda sucks, but you gotta pay up."

You're probably right, though. Single payer is the only thing that makes sense for health care. If you have a heart attack, you aren't going to do much shopping around or negotiating. Health care is not a free market and never will be. Isn't it strange how single payer systems tend to move to focus on preventative medicine. Single payer system also don't like shelling out budget to perform unnecessary, ethically questionable things like genital mutilations.

Re:Scope of the outbreak (1)

tomhath (637240) | about a year and a half ago | (#41724195)

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:Scope of the outbreak (1)

HiThere (15173) | about a year and a half ago | (#41729979)

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.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724427)

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.

Huh? First off, insurance companies love preventive care because it saves them lots of money in the long run. Are you seriously arguing that they aren't trying to lower costs to makes as much money as possible? That insurance companies are evil first and a business second?

Second, do you have any idea what happens when there isn't a copay or cost sharing? Ask any ER doc, or family practitioner in a rural area. When there's no cost, people come in for ridiculously trivial matters. Most people are fine, but there's a sizable portion of the population who abuse "free to them" healthcare.

Third, how is the government going to fix a shortage of labor if they a) reduce payments and b) offer it for free? In a free market the cost of healthcare would rise until supply met demand. We don't have that system, so there's a shortage. If you make it less profitable but increase utilization, guess what happens to that shortage...

In a later post you mention you stiffed the hospital on a rape kit. Should all of that treatment be free because someone was a victim? The same could be said of maybe half of all medical problems. Heck, look at the etymology of "injury". Hospitals, doctors, nurses, and the like are charitable and altruistic at heart, but if you don't get paid for your services or expenses then you can't provide them for long. Socialist healthcare addresses this, but introduces other problems (which I'd rather not get into, that debate is huge).

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724453)

I have a relative who received an injection at one of the clinics...When I heard about this on the news, I called her and we went down to ER and got things sorted (tested negative)

Based on hearing a news story you took your relative to the ER? Why in heaven's name would you make a trip to the ER? Couldn't you just, you know, call the hospital and see if there might be a problem? When there were no symptoms it doesn't seem like emergency.

Re:Scope of the outbreak (1)

flimflammer (956759) | about a year and a half ago | (#41724689)

What in gods name made you think they saw the report, panicked, he rushed over there in his car, grabbed their relative and dragged them to the ER based on that post? They could have done exactly what you said and deemed it important enough to make a trip out there.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41724813)

Because that's what she said they did, duh: "When I heard about this on the news, I called her and we went down to ER"

Re:Scope of the outbreak (1)

flimflammer (956759) | about a year and a half ago | (#41724933)

You're obviously missing that calling the hospital could have been easily implied here, like that they put pants on before they left the house. He was making a summary about the ordeal. You don't expect his story to say "I called the hospital, pressed 1 to get passed the main menu, then 0 for the operator. Waited on hold then talked to someone who told us we might as well come in," do you?

We also don't even know what the "story" on the news said. It might have said if you or someone you know might have been exposed to get them tested at the nearest facility.

But I digress, none of this really matters.

Re:Scope of the outbreak (1)

darkmeridian (119044) | about a year and a half ago | (#41725279)

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.

Re:Scope of the outbreak (0)

Anonymous Coward | about a year and a half ago | (#41725723)

but with privatized healthcare "preventative medicine" is practically a swear word.

Unless you are one of the god fearing, tax paying employees a private health plan. Then you don't have to wait for that critical condition to seek treatment for something which could have been prevented in a different system.
  Talking about different systems, even in a nationalized system the bills are payed by the patients themselves. A national health insurance might cover only the minimal treatment and the subscribed medicine brands are often switched to a generic brand with different mix of additives. Of course, the major part of cost of a system might be payed through taxes, but the bills might still remain. And yes, an idea of a national identity chipped card system with biometrics and associated digital health insurance card have caused some concerns for major Anglo-Saxon nations in the past.

zomieapocalypse has began? (0)

Anonymous Coward | about a year and a half ago | (#41724067)

I'm going down to my bunker anyway.

This was incompetence.... (0)

Anonymous Coward | about a year and a half ago | (#41724083)

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.

Free market will solve this! (0)

Anonymous Coward | about a year and a half ago | (#41724105)

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.)

Compounding Pharmacy system to blame (3, Interesting)

Jonah Hex (651948) | about a year and a half ago | (#41724123)

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

Re:Compounding Pharmacy system to blame (1)

Artifakt (700173) | about a year and a half ago | (#41725747)

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 condition were applied. They tested her to get a good isea of her idiosyncratic responses to various blood thinners, and in the end, a custom mix of blood thinners was used for several months to keep her within a narrow range that was just thick enough to avoid some major risks and still do the job. Since that time, she has used the same pharmacy to get various drugs that are often made with shellfish or egg processes run up in other media, although she feels that's just being on the safe side with some old allergies.
          Mom doesn't buy into the supposed Autism/Vaccine connection, but as she points out, If someone is worried about that, it's possible through some compounding sources to get vaccines that definitely were never preserved with Thimerosal, the chemical most often suspected by the anti-vaccine groups. The FDA allows quite a few vaccines to be manufactured in non-allergenic forms, particularly in 50%+ Glycerin bases, with either no or only microgram traces of Thimerosal. These are the sorts of uses that big chain pharmacies steer clear of, and while they may be right in not catering to the people who think autism and vaccines are connected, a lot of these other uses seem more solidly supported. (And, IMHO, it's really more important for a pharmacy to be sure they can do any of a wide range of procedures with full regard for safety, than to think they have to have a strong opinion on whether every single one of those procedures is the best bet medically or scientifically speaking - much of that should be left up to doctors, researchers, and, when needed, the government to make the final determination).
          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. In the US in the wake of this tragedy, we increasingly have two groups, one calling for massive regulation or simply shutting down all compounding, and the other chanting their mantra that government is always the problem, and people who call for the same oversight of the same processes, in an even-handed manner across the board, are unlikely to be listened to in this political climate.

Re:Compounding Pharmacy system to blame (1)

Rich0 (548339) | about a year and a half ago | (#41728973)

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 products was applied to an industry that has changed so that it operates on a national scale, supplying products that really should stand on their own.

If a compounding pharmacy is the only way to get a particular drug I can understand the need for some laxity. However, when the same drug is available from a traditionally regulated source and that drug is just as appropriate for the particular patient, then the drug with full quality controls should be used. Also, the scale of these companies should be regulated, so that a botched batch gets ten people sick, and not ten thousand. The regs were really written for some guy mixing up solutions in a flask, not in a 50k liter mixer.

Re:Compounding Pharmacy system to blame (1)

distilate (1037896) | about a year and a half ago | (#41739535)

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 (3, Interesting)

Stirling Newberry (848268) | about a year and a half ago | (#41724171)

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? (4, Insightful)

Okian Warrior (537106) | about a year and a half ago | (#41724377)

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?

Re:Babies and bathwater? (0)

Stirling Newberry (848268) | about a year and a half ago | (#41725167)

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?

Re:Babies and bathwater? (2)

Okian Warrior (537106) | about a year and a half ago | (#41725619)

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 would deprive children of potentially life-saving medicines and cause untold suffering for as long as your solution is in effect.

But please - do tell us about how the solution is for Congress to "close the formulation loophole" again.

You work for a drug company... right?

P.S. - Check the next response [to your post] down, which I believe elegantly puts the issue in perspective. Only 23 deaths in a population of 300 million, and this is the first one in many years. The risks are simply non-existant.

For comparison the USA around that many people die from wasp and bee strings every year.

Re:Babies and bathwater? (2)

Stirling Newberry (848268) | about a year and a half ago | (#41726045)

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 what was going on here. Instead a group of investors where manufacturing thousands of doses and introducing them into interstate commerce. There was no prescription in hand when the formulation was done, which in most states is a requirement for formulation.

After decades of incidents of patient adverse drug reactions, and even deaths, finally prompted the FDA to put pressure on the industry the result was a 1992 set of guidelines set out by the USP and co-ordinated with the other pharmacological organizations, primarily American Society of Health-System Pharmacists (ASHP) and National Association of Boards of Pharmacy(NABP). The guidelines and risks of such manufacture were codified in 2004 by the inclusion of Chapter 797 "Pharmaceutical Compounding—Sterile Preparations" included in The United States Pharmacopeia and The National Formulary issue by the USP. It specifically sets standards for sterile preparation and formulation, and was deemed enforceable as regulation.

From the forgoing, you are advocating illegal behavior that kills people, some I am just going ignore your baldly defamatory accusation that any of this in any way touches on specific dosage formulation for pediatric or geriatric patience. The issue is, and has been for decades, that formulation is an intrastate issue of the practice of medicine, but that unscrupulous and unsafe actors have used it to get into the unregulated intra-state commerce in pharmaceuticals. As noted, companies that have complied with labeling and regulation should have a private qui tam right of action, including the use of the False Claims Act as amended, to sue companies illegally and fraudulently manufacturing compounds, and introducing them into interstate commerce, and claiming that is formulation. This would allow the to file civil suits in Federal Court to collect damages and get injunctions.

For example in this case, the company in question had been repeatedly warned it was not in compliance with sterile manufacture, and its practiced prior to the regulatory enforcement of the guidelines in what would become chapter 797 was well known.

Finally your claim on risks is entirely fraudulent. There were 14000 affected doses, 236 infected individuals, which is a 1% infection rate, and 23 deaths so far, which is a CFR of 10%. On net, that is more deaths in the same time in that population cancer or heart disease. 300 million people didn't get steroid shots the the last three months, so the are not part of the risk pool. That's Public Health Stats 101. In addition there is another fact which you conveniently attempted to cover up, and that those infected have an uncertain prognosis, and many have suffered non-fatal strokes. They haven't recovered. In fact, no one who has been infected has recovered yet, so the CFR is likely to be worse. This for a treatment to a non-life threatening condition.

In summary, the risk number you put forward is a deliberate lie, you mis-state what the loophole is, you accuse me of attempt to restrict actual formulation, and then have the gall to say I'm a shill? On the contrary, the evidence indicates, that if anyone is shilling, it is you, for a company that willfully ignored the standard of care, and has with gross negligence exposed thousands, sickened hundreds, and killed or disable hundreds in the space of a few months.

Re:Babies and bathwater? (1)

Stirling Newberry (848268) | about a year and a half ago | (#41726095)

>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:Babies and bathwater? (1)

HiThere (15173) | about a year and a half ago | (#41730715)

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 and pharmacists who are experienced in this area have a series of "rules of thumb" that "sort of work". The tests required to bring these procedures up to standard are regularly proposed, and regularly rejected by the drug companies, because of the costs involved. (They're quite happy selling for off-label use. It's off label, because there aren't any approved tests that evaluate it. And those tests are expensive.)

Note that this is also true for lots of other drugs. Often a drug will only get tested for use against a particular disease when the patent on one use is about to run out. This allows the patent to be issued for the new use (which previously was off-label) and maintains the patent on the drug. Similarly, combinations of asprin & ... (various drugs) have been replaced by combinations of acetominophin & ... (those same other drugs) to extend the life of the patent, even when the new formulaiton is inferior to the old. The old one just becomes unavailable. One of the drugs that I take to control gout (colchicine) has recently (a couple of years) gone BACK into "no generic formula allowed". Nobody has been able to give me a better explanation as to how that happened than "some money must have changed hands". So I don't trust the pharmaceutical companies to have an ethical principle other than "The customer be damned, give me the money." It''s true that the FDA has been largely captured by the pharmaceutical companies, but it's better than non-regulated, if, because of the WAY that the regulations are implemented, not enough better. (E.g., FDA officials, all management levels, should be prohibited from EVER taking ANY remuneration of ANY form either while they work for the agency, or afterwards. That one regulation, if enforced, would help things immensely.)

Re:Babies and bathwater? (1)

Rich0 (548339) | about a year and a half ago | (#41729081)

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 figures out how to test the stuff so that anything that could go wrong would be spotted, and documents the living daylights out of that (I doubt the compounding pharmacy does much testing at all).
3. The company follows the process in #1 and #2 to make a whole bunch of doses of the new formulation.
4. The company injects a bunch of healthy volunteers with the new formulation, and collects blood/urine samples at regular intervals. These are tested for drug concentrations.
5. The company does analysis of all this data against corresponding data for the established drug and demonstrates that the new one is just as safe and behaves in the same way.
6. The company sticks containers of the new formulation in a stability chamber for months to years to figure out how long it lasts, following all the tests in #2 to confirm.
7. The company writes up a few thousand pages of reports on all of the above, then waits for the FDA to tell them if it is OK.

Suffice it to say that all costs more than just whipping something together and dropping it in the post. It is also a LOT safer.

I have no issues with compounding pharmacies, but they should be a solution for people who have no alternative, and they should operate on small scales where a mistake harms only a few people. The problem was that the company in question was operating on the scale of a small pharmaceutical plant but without any of the regulatory safeguards. Even the big companies mess up, but usually not this badly (most of the high profile problems have been with the drug itself, and not the quality of its manufacture - that is really a separate matter, though obviously an important one).

Re:FDA (1)

englishknnigits (1568303) | about a year and a half ago | (#41725357)

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 laws, good practices, etc. to prevent a one off, unfortunate situation that happened in one pharmacy. Those types of over reactions tend to do more harm than good.

Let me ask this, if there were two violations under our current system, then why do we need to change things? Punish the two violations (enforce the laws, shocking I know) instead of creating more task forces, more laws, and more regulations.

Re:FDA (1)

pedestrian crossing (802349) | about a year and a half ago | (#41726333)

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.

Re:FDA (1)

englishknnigits (1568303) | about a year and a half ago | (#41730009)

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 and tragic but not national news worthy. Everyone knows children sometimes get kidnapped, reporting it on a national level is just free drama for the 24 hour news cycle and people who want to "watch their stories."

Rarity of infection (4, Interesting)

Stirling Newberry (848268) | about a year and a half ago | (#41724203)

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.

Re:Rarity of infection (-1)

Anonymous Coward | about a year and a half ago | (#41724315)

Coxsackievirus*

heheh you said cock sacky

Re:Rarity of infection (0)

Anonymous Coward | about a year and a half ago | (#41724613)

Good post. I had bacterial meningitis as a child (mid-80's), the doctor said I only survived (it was "a bad case" as they say) because my parents spotted the symptoms very early, which they did because my older brother had had viral meningitis four years prior. He had permanent, pretty severe - he is hard of hearing - auditory nerve damage from it, so even viral meningitis, even if rarely fatal, should not be treated lightly.

Re:Rarity of infection (1)

circletimessquare (444983) | about a year and a half ago | (#41725809)

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 (4, Interesting)

miniMUNCH (662195) | about a year and a half ago | (#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 (4, Informative)

PPH (736903) | about a year and a half ago | (#41724807)

Compounding pharmacies [wikipedia.org] are regulated by the states, not the FDA the way drug manufacturers are.

Re:The FDA blew it, among others (1)

miniMUNCH (662195) | about a year and a half ago | (#41732671)

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 FDA regulated generic parenteral (injectables) manufacturing facilities all over the US and Canada that... this whole scenario just does not compute. Compounding chemists preping parenterals without complete sterility assurance (via rigorous validation and QC testing) is pretty much a disaster, like the very one we are discussing, waiting to happen; I think the doctors ought to know better, as well.

Re:The FDA blew it, among others (0)

Anonymous Coward | about a year and a half ago | (#41725325)

I know who is not going to get any sort of punishment: senior management. I'm sure some sort of escape goat is already being arranged.

Re:The FDA blew it, among others (0)

Anonymous Coward | about a year and a half ago | (#41726293)

1. Shouldn't you be occupying someting?
2. Escape goat? Really?

Amphotericin B liposomal (2)

wherrera (235520) | about a year and a half ago | (#41726213)

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.

Re:Amphotericin B liposomal (1)

miniMUNCH (662195) | about a year and a half ago | (#41732961)

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 in a phospholipid bi-layer vesicle, effectively an engineered cholesterol nanoparticle, which gives the drug more of a time release behavior in the bloodstream and significantly reduced filtration rate [in liver and kidneys]... so long story short: the Ambisome formula works much better than Amphotericin-B straight and the severity of adverse effects is much, much lower. That much is clinically proven. There are other lipid encapsulated formulations of Amphotericin-B (Ambisome competitors)... don't know about those formulations, but they probably also work better than Ampho-B straight.

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

dandelionblue (2757475) | about a year and a half ago | (#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.)

Re:Recalls aren't that complicated... (1)

flimflammer (956759) | about a year and a half ago | (#41724727)

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?

Re:Recalls aren't that complicated... (1)

merlinokos (892352) | about a year and a half ago | (#41726687)

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 valuable.

Another possibility is that due to devolution of powers, including medicine, the hospital pharmacies and PCTs are the authorities which are responsible for maintaining a list of practicing pharmacies in their area. If that's the case, it's a no-brainer to have them send out the notification, since they're the final arbiters of truth regarding registered pharmacies.

Either option seems plausible to me.

Re:Recalls aren't that complicated... (1)

dandelionblue (2757475) | about a year and a half ago | (#41730351)

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. Additionally, the national register of pharmacy premises does not include any details on doctors or dentists, so you'd have to go back to either the PCTs (who again hold data on the local level) or their regulatory bodies whenever doctors or dentists need recall information. Doctors and dentists do hold some stock of drugs and sometimes need to know about recalls.

Re:Recalls aren't that complicated... (1)

dandelionblue (2757475) | about a year and a half ago | (#41730275)

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 contact the GPhC and wait for the GPhC to pass it on. The GPhC also only work Mon-Fri 9-5.

Things may well change as the PCTs are due to be abolished next year, but requiring the PCTs to contact all pharmacies on their patch reduces the numbers that any one body has to contact. (PCTs cover areas of up to about 1 million patients. Their replacements cover much smaller areas, but of course there's more of them.)

Re:Recalls aren't that complicated... (3, Interesting)

girlintraining (1395911) | about a year and a half ago | (#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 which stage does the US system differ?" (2)

circletimessquare (444983) | about a year and a half ago | (#41725857)

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

Re:Recalls aren't that complicated... (1)

tazan (652775) | about a year and a half ago | (#41729195)

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.

Re:Recalls aren't that complicated... (1)

dandelionblue (2757475) | about a year and a half ago | (#41730651)

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.

More Drugs tainted!!! (1)

AssholeMcGee (2521806) | about a year and a half ago | (#41726735)

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.

Re:More Drugs tainted!!! (1)

DeadCatX2 (950953) | about a year and a half ago | (#41728705)

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...

List of clinics? (1)

DeadCatX2 (950953) | about a year and a half ago | (#41728659)

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:List of clinics? (1)

Rich0 (548339) | about a year and a half ago | (#41739637)

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 these sources for things which are otherwise manufactured by the book. I read a blog by some guy who works for a generics company that found that they had trouble competing on price since some of those compounders started with materials not classified for human use (orders of magnitude cheaper), while they had to follow proper quality controls and source proper materials (you know, stuff that is controlled so that you don't get mad cow disease, contamination, or who knows what else).

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