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"We’re giving just enough to prevent them from dying."
June 23, 2013 8:01 AM   Subscribe

Because of nationwide shortages, Washington hospitals are rationing, hoarding, and bartering critical nutrients premature babies and other patients need to survive. Doctors are reporting conditions normally seen only in developing countries, and there have been deaths. How could this be allowed to happen?

Current Drug Shortages Index

FDA announces import of injectable nutrition drugs
posted by the man of twists and turns (113 comments total) 17 users marked this as a favorite

 
But in Canada it's socialism! And you might have to wait for care! Am I doing this right?

Any health care system that is based on making money off of sick people will fail at it's purported mission (taking care of the sick) and succeed wildly at its principal mission - making money.
posted by nevercalm at 8:16 AM on June 23, 2013 [72 favorites]


Sodium Chloride 0.9% (5.8mL and 20mL) (initial posting 5/4/2012)
Sodium Chloride 23.4%


WTF? There is a shortage of salt solutions? On a planet that has oceans full of salt water?
posted by charlie don't surf at 8:21 AM on June 23, 2013 [8 favorites]


WTF? There is a shortage of salt solutions?

Perhaps no one has linked to a source of 'how to make your own Lactacted Ringers' so that someone can make their own? You'd think the intravenous Vitamin C advocates would have such.....
posted by rough ashlar at 8:24 AM on June 23, 2013 [2 favorites]


A crisis like this screams for a bad guy. But in this case, depending on whom you ask, there are either no villains or several.

Cumbersome FDA rules and low margins would seem to create disincentives for manufacturers. No "bad" guy but plenty of unmotivated ones.
posted by three blind mice at 8:27 AM on June 23, 2013 [5 favorites]


"...nationwide shortages caused by a combination of factors—manufacturing problems, a market with few incentives for companies to produce low-profit drugs, and the government’s delayed and inadequate action—thousands of patients are being malnourished"

And yet, it is framed as "How could this be allowed to happen?" There is no question, the cause is very clear: corporate malfeasance and regulatory capture. However, I'm sure there are a lot of rich people who are much happier that we pose questions rather than call out their destructive behavior.
posted by frijole at 8:28 AM on June 23, 2013 [22 favorites]


Before clicking, my guess is some form of greed.

After clicking, my guess is the exact kind of market and regulatory failure that critics of the US healthcare "system" have been pointing out for decades.
posted by flabdablet at 8:29 AM on June 23, 2013 [17 favorites]


Making your own Ringer's lactate without FDA approval would seem to invite ruinous lawsuits - a huge disincentive as such torts are intended to create.
posted by three blind mice at 8:31 AM on June 23, 2013 [2 favorites]


Making your own Ringer's lactate without FDA approval would seem to invite ruinous lawsuits - a huge disincentive as such torts are intended to create.

And yet, Humans figured it out in the 1880's. But hey, rules/regulations/lawyers is why a metaphorical pich of salt in water is "worth" whatever is charged for a Ringer. Perhaps the book "Where there is no Doctor" tells one how one can make a safe ringer?
posted by rough ashlar at 8:34 AM on June 23, 2013 [2 favorites]


Horrifying, horrifying. Journalism at its best.

For the record: I, for one, do not consider requiring that nutritional supplements be free of visible glass or silicone particulates to be, uh, "cumbersome FDA rules."
posted by purpleclover at 8:42 AM on June 23, 2013 [33 favorites]


This is totally infuriating in practice, even when it's patients less string-tugging than NICU babies. (We don't have phosphate outside of the ICU? You're only giving lipids on Thursdays? You're saying there is a national shortage of fat??)

The article touches on how complex the market is for these things because of the cliff-shaped margins. Having n-50 units of phosphate is a disaster. Having n+50 is no better than n. The price on either side has a really small effect on my willingness to use more / less. Access to international just-in-time supplies is limited because we really care about quality (and have laws reflecting that), but we would like to continue paying third world commodity prices for saline flushes. It really is not a case of the usual bogeymen.
posted by a robot made out of meat at 8:46 AM on June 23, 2013 [3 favorites]


And yet, it is framed as "How could this be allowed to happen?" There is no question, the cause is very clear: corporate malfeasance

If the citizens of Shelbyville need a new road into town, is it corporate malfeasance if Acme Road Building doesn't, on its own, build such a road?

The solution to this, as in nearly every problem in U.S. Healthcare, is Big Government, under public mandate, hiring the Smart People Who Know What's Best to Do and do things in the public interest.

Yeah, I'm naive, but the older I get and the more experience I have in health care, the more this is true. I don't believe we will see a strong, centrally organized health care system in my life, but the more we turn to capitalism to solve these problems, the less well it serves us.
posted by Slarty Bartfast at 8:46 AM on June 23, 2013 [76 favorites]


Why are we having so many problems importing stuff from overseas? Is it just a case of protectionism/regulatory capture?
posted by snickerdoodle at 8:53 AM on June 23, 2013


After clicking, my guess is the exact kind of market and regulatory failure that critics of the US healthcare "system" have been pointing out for decades.

the story is roughly (from the article):

1)US domestic injectables manufacturers have not been investing in production in a long time. production lines use old methods and old equipment.

2) supply is tight so that if even one production line is taken off there will be shocks to supply

3) production quality both declines and doesn't meet modern standards e.g. one major manufacture obtains FDA approval to release a product which is unsafe without secondary filtration to remove "particles" from the solution

4) FDA gives "warning notices" to non-complying manufacturers who take production lines off and sometimes don't bring them back on

5) our Tea Party congress in conjunction with industry lobbyists blame "FDA regulation" for reducing supply

6) FDA regulations for importing drugs from foreign sources are cumbersome and effectively trade protection for domestic manufacturers.

So, the cumbersome FDA regulations here are really the ones which keep foreign suppliers out of the US market. Yet, at the same time, bringing in foreign supplies would reduce, even further, the incentive for domestic producers to invest in production lines, which is the root of the problem.

If only simple "greed" was the problem here. The health care system in the US is broken and there aren't simple solutions. But, almost every complex social system in the US is breaking down: manufacturing, transportation, health care, education... The US is like the old USSR: powerful, corrupt, and hollow on the inside.
posted by ennui.bz at 8:55 AM on June 23, 2013 [36 favorites]


The solution to this, as in nearly every problem in U.S. Healthcare, is Big Government,

Say, hows that Big Government working out for the capture and retention of phone info/email? Is that Big Government solution solving the problem it is claimed to solve? How much money is being spent to solve that problem?
posted by rough ashlar at 8:59 AM on June 23, 2013 [2 favorites]


Oh Free Market, you scallywag… there's really no money in keeping the children alive?

Why is the FDA person all gold braid and ribbons? They're no Cap'n Crunch. If they have to have a uniform, why not a nicely trimmed lab coat?
posted by scruss at 9:00 AM on June 23, 2013 [1 favorite]


ABSOLUTELY NOT FUCKING ACCEPTABLE.
posted by Benny Andajetz at 9:01 AM on June 23, 2013 [6 favorites]


My wife's job is working with situations like this, as a pharmacy tech in a hospital. She says they are short of lots of things all the time.

It's the manufacturers. Shortages pay better than surpluses.
posted by dglynn at 9:05 AM on June 23, 2013 [4 favorites]


Why is the FDA person all gold braid and ribbons?
Uniforms of the US Public Health Service
posted by the man of twists and turns at 9:08 AM on June 23, 2013 [6 favorites]


What do they expect? The little freeloaders haven't earned anything. Why should private enterprise subsidise their parasitic lifestyles? This isn't Communist France, you know. 🍔
posted by acb at 9:08 AM on June 23, 2013 [15 favorites]


Perfectly acceptable. Watch in horror and shame as the public continues to accept it, given that the alternative involves supporting the systemic changes necessary to prevent it.

This kind of shit is just going to keep on happening for as long as America continues to turn dry-mouthed with fear at the prospect of anything that looks even vaguely like socialized medicine.
posted by flabdablet at 9:09 AM on June 23, 2013 [20 favorites]


It's hard to strangle an adult with only one invisible hand.
posted by Stonestock Relentless at 9:11 AM on June 23, 2013 [8 favorites]


Shortage per Manufacturer: (promethazine injection)
Production temporarily suspended due to other priorities
Hospira, Inc.
Customer Service: 1-877-946-7747

American Regent is currently not releasing Potassium Acetate Injection, USP.
American Regent/Luitpold:
1-800-645-1706

Shortage per Manufacturer: American Regent is currently not releasing Magnesium Sulfate Injection.
American Regent/Luitpold
1-800-645-1706

just an example....that second link is full of them
posted by sexyrobot at 9:11 AM on June 23, 2013 [3 favorites]


Wait, the head of the FDA gets to wear a BDU (battle-dress uniform)?

Mind blown, and then rinsed with saline and placed in a nutrient bath.
posted by zippy at 9:16 AM on June 23, 2013 [4 favorites]


also, since this appears to have become an emergency, is there any way that local university chemistry labs could pitch in? :/ this is awful!
posted by sexyrobot at 9:17 AM on June 23, 2013 [4 favorites]


> how's that Big Government working out for the capture and retention of phone info/email?

It tells me it's doing fine, thanks… oh, and you have a family birthday coming up, also you should go easy on the anchovies on the pizza orders in future, you know they're not good for you.

The USA doesn't have Big Government. It never really has; maybe some time during New Deal years there was something close, but that was in response to a crisis. You have expensive, ideologically-driven government, that seems far happier to outsource to expen$ive ¢ontractor$ than roll up its own sleeves and deal with the problem itself.

Making these injectables isn't hard. Remaking the financial system so that the continued production of low profit margin but high external benefit products is the hard part.

To paraphrase Frank O'Hara: “oh America we love you get up”.
posted by scruss at 9:17 AM on June 23, 2013 [9 favorites]


The rationing pits patient against patient, forcing health-care practitioners to decide who gets a critical nutrient and who has to go without. Says Mirtallo: “I can’t imagine another time in my professional life when we were accepting the unacceptable.”


Oh Dr. Mirtallo, if only I could borrow you for an afternoon. You'd be amazed at what's been going on in primary care.

I have always hated the neonatal ICU. It's the flip side of the inequities of health care coin. Nowhere else in medicine do you see so many resources thrown so hard, without any question, to sick patients where tiny gains are *so expensive.* Just to illustrate, this week we ran out of a commonly used injectable antibiotic. There's been a temporary shortfall in our funding and we simply decided this was something we'd wait to purchase vs oxygen tanks and bandages. Another illustration: an alcoholic, drug addicted patient who's had *two* preemies in the past, both totally paid for by the state and out of her custody, came in pregnant again. After her last birth, we worked really hard to get her in for an IUD, but with a newborn in the NiCU, and heavy duty social chaos, she never managed to get back during the 2 months after the baby's birth when Medicaid would still pay for contraception and she had no funding afterward. So now she's drunk and pregnant again with a baby she doesn't want. Don't even get me started on her options for drug and alcohol treatment.

NICUs are where health care dollars are spent the most inefficiently with no expense spared for the extreme short term gain. I'm not saying we shouldn't be throwing everything we can at saving preemies. Modern neonatal medicine *is* a miracle, and many many of these kids go on to normal lives. But I think it's telling that the spare-no-expense fields of medicine are starting to see the same kind of problems we've been seeing in primary care. I have a feeling if society could get it together to give a lady an IUD we could probably get it together to get a preemie some zinc.
posted by Slarty Bartfast at 9:20 AM on June 23, 2013 [63 favorites]


If these things were reclassified as Doritos flavors there'd be no problem with manufacture, distribution and delivery in any quantity you can imagine.
posted by George_Spiggott at 9:23 AM on June 23, 2013 [15 favorites]


Keli Hawthorne, the dietitian at the USDA/ARS Children’s Nutrition Research Center in Houston, says she’s not surprised that hospitals are muzzling their dietitians because they don’t want to scare people or attract blame. “There’s concern people would think we’re not appropriately caring for their infant,” she says. “And the fact is we’re doing the best that we can.”

But you're not caring appropriately for their infant, and if that's "the best [you] can," that suggests that there is a major problem that people ought to be aware of. Can someone help me understand what the benefit is of maintaining this smoke screen?
posted by corey flood at 9:25 AM on June 23, 2013 [3 favorites]


Slarty Bartfast:

I sympathize with your viewpoint, and believe you are totally correct. But that's a totally separate concept than being short of saline, potassium and zinc, no? I can't see how this issue doesn't go directly to the ill side-effects of medicine for profit.
posted by Benny Andajetz at 9:26 AM on June 23, 2013


Slarty Bartfast:
If the citizens of Shelbyville need a new road into town, is it corporate malfeasance if Acme Road Building doesn't, on its own, build such a road?

The solution to this, as in nearly every problem in U.S. Healthcare, is Big Government, under public mandate, hiring the Smart People Who Know What's Best to Do and do things in the public interest.
I totally agree with your solution, but don't forget the other half of what I said: "...and regulatory capture."

Why can't the government effectively regulate this (and many other) industries? The massive efforts of industry players to manipulate the systems that are meant to regulate them.

Why can't the government provide for basic needs like this, especially when the private sector is failing to do so? Because the public has been convinced the government can't do it or that it would be wrong.

Neither of these things was an accident, and I don't think its a stretch to lump them in under the banner of "corporate malfeasance," but maybe there's a better way to describe the destructive behavior of these enterprises.
posted by frijole at 9:50 AM on June 23, 2013 [1 favorite]


sexyrobot, I wondered the same thing. The Washington area is home to several world-class universities which presumably have amazingly modern chemical labs of every possible persuasion. None of these chemicals are particularly expensive or hard to source. But it's FDA regulations, and fear of lawsuits, that keep anyone from pitching in. The hospitals and the universities who saved lives by compounding these injectibles would be first fined (by the FDA) and then sued (by everyone who didn't have a perfect reaction) into oblivion. But if there's a shortage and the hospital was "powerless" to resolve it then no one can sue anyone. Act of God, whatever that's supposed to mean.

Maybe the solution to this issue is hospital-owned or insurance-company-owned coops. The for-profits certainly don't seem to be willing to resolve it, and the government would sooner allow people to die than allow equivalent sources from developed countries in without onerous inspection requirements that, frankly, no one in Sweden or Switzerland wants to be bothered with. It's not just medicine - the US insists on doing lots of stuff its own way without regard for the impact these policies have on anyone. In many European countries an American cannot open a bank account, because no one can be bothered to comply with the US' ridiculous special rules for bank reporting. This isn't much different, except people are dying of course.
posted by 1adam12 at 9:53 AM on June 23, 2013 [2 favorites]


Any health care system that is based on making money off of sick people will fail at it's purported mission (taking care of the sick) and succeed wildly at its principal mission - making money.

Pharmaceutical manufacture is done by for-profit companies all over Europe, they seem to be able to make both money and medicine.

And yet, it is framed as "How could this be allowed to happen?" There is no question, the cause is very clear: corporate malfeasance and regulatory capture.

Did the pharmaceutical manufacturers 'capture' the FDA into sending them warning letters? Surely this isn't a great example of regulatory capture.
posted by atrazine at 10:00 AM on June 23, 2013 [1 favorite]


also, since this appears to have become an emergency, is there any way that local university chemistry labs could pitch in? :/ this is awful!

University chemistry lab ≠ commercial chemical production facility. We're talking, in the case of simple, ubiquitous, Ringers, for instance, production in the range of hundreds (if not thousands) of gallons at a time. And, beyond merely creating the chemicals, there's also packaging them in the appropriate forms (bottles, drip bags, etc.). Commercial chemical production is on a scale no university lab (or even many labs working in tandem) can approach.
posted by Thorzdad at 10:01 AM on June 23, 2013 [11 favorites]


I sympathize with your viewpoint, and believe you are totally correct. But that's a totally separate concept than being short of saline, potassium and zinc, no?

his point is that failure to properly allocate resources is already commonplace in primary care... and that's the issue here. meanwhile, "preemies" represent massive costs to the health-care system. an effective system would invest resources to prevent children being born premature due the health of the mother i.e. IUDs for addicts. that's one of the ways "Obamacare" is supposed to "bend the curve" of health-care costs. But you can see with the IUD example the problem is quite a bit bigger than just health-care. In general, the reasons why people don't get adequate health care in the US are more complicated than the lack of insurance. With the current system of insurance, primary care is already falling apart.

Why can't the government effectively regulate this (and many other) industries? The massive efforts of industry players to manipulate the systems that are meant to regulate them.

I can't see how this issue doesn't go directly to the ill side-effects of medicine for profit.

health care (but not health insurance for most people) operates for profit in Europe... it's not a simple issue of profit. the failure of health care in the US is a broad political problem involving issues of power, economics, technology, social class, race, and on and on. there are plenty of ways the US could have a functioning health-care system, and plenty of people who would know how to implement it. the problem is political.
posted by ennui.bz at 10:04 AM on June 23, 2013 [8 favorites]


Making these injectables isn't hard.

And yet - no links on how to's that are to be trusted.

So it can't be that easy.....
posted by rough ashlar at 10:04 AM on June 23, 2013


This reminds me of a ridiculous local story I heard. During WWI, Bayer held a patent on aspirin that was valid in the US. So even while the US was at war with Germany, they honored the patent on aspirin, so it was not available. As the story goes, my local university chemistry department decided they would defy the patent make batches of bootleg aspirin. It was distributed to hospitals and the military fairly openly. I heard this through our alumni magazine, I suspect the story became exaggerated over the years, or was suppressed in the fear that Bayer would go after the university for old royalties, or influence grants.

But still, basically any chem undergrad could make a lot of these drugs. Some of them, like basic saline solutions, I could make as a sophomore in high school chemistry class.
posted by charlie don't surf at 10:04 AM on June 23, 2013 [4 favorites]


The amount of regulation the FDA is currently doing barely suffices given the standards the public reasonably expects of its medicines. I don't believe cutting the regulatory burden is going to lead to one single production line opening up. Hell yes, quality control is expensive, you're putting it into the veins of 24 week preemies! Shit slips through the FDA's watchful eye all the time, and the cost added *ought* to be higher.
posted by Slarty Bartfast at 10:10 AM on June 23, 2013 [4 favorites]


But still, basically any chem undergrad could make a lot of these drugs. Some of them, like basic saline solutions, I could make as a sophomore in high school chemistry class.

But to make them in mass quantities, insuring purity, safety, and quality would require a well-thought out production line and and investment of money. And, of course, why invest in quality, safety, and purity when it's so easy to make... What's your argument: FDA regulations make this simple product hard to make? Without government assurance of safety and effectiveness this is exactly the sort of product (because it isn't terrible hard to make) which would be produced cheaply and badly.
posted by ennui.bz at 10:10 AM on June 23, 2013 [3 favorites]


Did the pharmaceutical manufacturers 'capture' the FDA into sending them warning letters? Surely this isn't a great example of regulatory capture.

What was the process that resulted in warning letters, rather than something more effective and in the public interest?

I'm pretty comfortable assuming that, like pretty much everything else that's been going on in the regulatory sphere for a while now, there was a lot of involvement from industry-funded lobbyists. And that is regulatory capture.
posted by frijole at 10:12 AM on June 23, 2013 [2 favorites]


Can we talk about this sentence on page 6?

According to CDC documents, federal officials can deploy SNS resources even in the instance of a single case of smallpox.

Yes. A single case of smallpox is a Big Deal. Smallpox or attacks with weaponized anthrax or radioactive contaminants is Scary. Is it more likely to happen than these sick kids dying? No. Many already have, but Americans can only collectively prepare against things that are Scary. We will only ask our government to prepare against the giant scary, highly improbable chances of something happening, but not against the things that are killing us today that are more complicated to fix than stockpiling smallpox vaccine.

Its the 9/11 mindset. Protect us at all costs from the boogeyman blowing up a building or a plane. Ignore the people dying every day from preventable violence.
posted by fontophilic at 10:14 AM on June 23, 2013 [23 favorites]


Slarty Bartfast:

I sympathize with your viewpoint, and believe you are totally correct. But that's a totally separate concept than being short of saline, potassium and zinc, no? I can't see how this issue doesn't go directly to the ill side-effects of medicine for profit.


It's that the things that make sense to do, in a 100% capitalist system don't get done, even in the NICU when the expense society is willing to pay is effectively infinite.
posted by Slarty Bartfast at 10:15 AM on June 23, 2013 [5 favorites]


rough ashlar, no, that does not follow. And the reason you aren't finding how-to's online is because they're not necessary, as most of these chemicals are available for stunningly cheap prices from chemical supply houses. In most cases making them in the lab wouldn't be necessary. That's different for human medical use of course, but making zinc sulfate solution in the lab is kind of silly when you can buy a big old jug of the stuff for less than $20.
posted by 1adam12 at 10:15 AM on June 23, 2013


... it's not a simple issue of profit.

Yeah. I'm guilty of a little shorthand there. It's one thing to make a profit while fulfilling a necessary goal. It's a whole 'nother thing to totally bail on your necessary goal simply because it doesn't bring in enough ducats to satisfy you.
posted by Benny Andajetz at 10:19 AM on June 23, 2013


Say, hows that Big Government working out for the capture and retention of phone info/email?

Last time I checked, they were pretty fucking great at that. It's just not something they should be doing.

The issue isn't "big government," per se, any more than smashing your thumb is a "big hammer" problem. It's what you do with a tool that powerful that matters.
posted by fifthrider at 10:20 AM on June 23, 2013 [13 favorites]


Human injectable solutions are not just bucket chemistry. You have to ensure that every step along the way was not contaminated with endotoxins or other pyrogens. All of the packaging and tubing must also be endotoxin free. Worst case is something like the fungus contamination of steroids seen recently in the news.
posted by benzenedream at 10:29 AM on June 23, 2013 [9 favorites]


> Human injectable solutions are not just bucket chemistry.

Sure, but the point is that getting these things right are "easy" from the perspective of our technological society, which cranks out very similar stuff with similar restrictions, things like "contact lens solution", by the millions of gallons.

The fact that capitalism can't get itself together to do this easy thing which would save many lives and save people a huge amount of money shows that capitalism isn't working well to solve this issue.
posted by lupus_yonderboy at 10:36 AM on June 23, 2013 [8 favorites]


Oh America, you scream so loudly to let the free market decide and to keep taxes as low as possible, but then you cry when it doesn't do what you want and your children suffer.

You're mad because the fish isn't climbing the tree, and you're yelling at the fish to try harder.
posted by blue_beetle at 10:43 AM on June 23, 2013 [18 favorites]


A pure 'free market' in healthcare would not be based upon private, profit-based insurance providers. A totally free market would have no insurance providers whatsoever and just let those who can afford to do so survive and live well. What America has is private, profit-based entities doing badly what governmental organizations can do better... not perfectly, since what is required for that would be all parties acting in good will and recognizing their limitations, and no system can make that happen (hey, it's even possible in the current system, except that the current system makes DISincentives for that).
posted by oneswellfoop at 10:52 AM on June 23, 2013 [3 favorites]


also, since this appears to have become an emergency, is there any way that local university chemistry labs could pitch in? :/ this is awful!

But still, basically any chem undergrad could make a lot of these drugs. Some of them, like basic saline solutions, I could make as a sophomore in high school chemistry class.

I understand what you're saying, but... any chem undergrad could also ROYALLY FUCK UP a lot of these drugs. There's a reason we make these in dedicated facilities with lots of quality control checks - and even then things sometimes get fucked up. But seriously, the idea of have your local lab produce hospital grade solutions for preemies? I've worked in your local lab. That is a TERRIBLE idea.
posted by maryr at 10:54 AM on June 23, 2013 [5 favorites]


Sure, but the point is that getting these things right are "easy" from the perspective of our technological society, which cranks out very similar stuff with similar restrictions, things like "contact lens solution", by the millions of gallons.

Contact lens solution does not go directly into the veins of infants with little to no immune systems. And remember a few years ago when there were some contaminated batches? Imagine if that had been babies.
posted by maryr at 10:55 AM on June 23, 2013 [3 favorites]


The longer I work in molecular biology, the less I trust the sterility of anything. Bacterial life finds a way.
posted by maryr at 10:56 AM on June 23, 2013 [12 favorites]


> Contact lens solution does not go directly into the veins of infants with little to no immune systems.

No, it goes into the eyes of adults - one of the most sensitive places in an adult body (and also very close to other important things like your brain). Perhaps less sensitive that an neonate - but pretty darned sensitive.

> And remember a few years ago when there were some contaminated batches?

A problem that has also been seen even more recently with these fluid nutrients, as the original article pointed out.

So are you claiming that these solutions are just too difficult to make on an industrial scale? Sorry, I don't buy it - particularly as the original article also points out that Europe has no such issues, but for some reason (read: protectionism) the United States is unable to import the missing fluids.
posted by lupus_yonderboy at 11:05 AM on June 23, 2013 [1 favorite]


It's hard to go through the article and answer their question, but I think this is it:

Because of a big increase in the number of generic injectables coming off patent protections since 2008, manufacturers may have diverted some of their limited capacity to higher-profit drugs ... when demand outpaces supply, there’s little incentive for them to shift resources around so they can produce more of a low-profit drug.

Other hospitals have turned to “gray market” vendors: private, unauthorized suppliers who ... sell them to hospitals at huge markups, in one case more than 8,400 percent.

Because these consortiums [of GPOs] have driven the prices of generic injectables so low, some say, manufacturing them isn’t profitable.

“I have friends in other countries who could get me some, but that would be illegal,” one doctor says.


So the manufacturers don't make enough profit on the nutrients, so they don't make any. That's reasonable. The solutions are (1) pay more for the nutrients (but US health spending is already huge), or (2) importing them from overseas (currently forbidden by the regulator, apparently, probably protectionist sentiment), or (3) using state money to set up plant to manufacture the nutrients (like you do for, say, military equipment made in prisons.) I'm guessing (3) would be an odd solution for the US, and I'm not sure it would save money in the long run over leaving it to a correctly-incentivised private sector.

So it's a cost/rationing issue, common to all healthcare systems. The US healthcare system (generalising) won't pay the amount of money required to get the nutrients made. They are available at a higher cost, just not at the price point you want to pay.
posted by alasdair at 11:08 AM on June 23, 2013


Contact lens solution does not go directly into the veins of infants with little to no immune systems. And remember a few years ago when there were some contaminated batches? Imagine if that had been babies.

Not that I'm suggesting we tell the FDA to cut back on the regulatory activities, since it seems a significant portion of the warning letters they sent out were about conditions that affected the safety of the medication created within. But the current shortages are also leading to potentially unsafe practices, as outlined in the article—things like reusing the same vial of nutrients for several syringes, which could lead to cross-contamination issues but are necessary to eke out every useful drop of nutrient from the vial.

In other words, what doctors and nurses are doing now already contravene best safety practices. Until there's a more permanent solution to this, we're basically talking about what level of safety we're willing to live with.
posted by chrominance at 11:11 AM on June 23, 2013 [3 favorites]


> The US healthcare system (generalising) won't pay the amount of money required to get the nutrients made.

From the original article:

"Several doctors say their hospitals would pay a markup of 50 percent or higher if they could be confident in a stable supply of IV nutrition."

(I missed the edit window for my previous comment - but I note that the FDA is allowing imports of fluid. Thank goodness.)
posted by lupus_yonderboy at 11:12 AM on June 23, 2013


But seriously, the idea of have your local lab produce hospital grade solutions for preemies? I've worked in your local lab. That is a TERRIBLE idea.

I get that. I do. But when the alternative is to just let someone die, which is apparently what's been happening, then arguing about this seems like misplaced priorities. Anyone who suggested that an industrial chemical supplier would be an acceptable long-term source for these substances would of course be crazy. But in an emergency, you have to make bad choices. In this case it is either import foreign material (breaking the law) or make your own (breaking the law). And really, from the article it sounds like the supposedly safe suppliers of these substances are doing a shit job themselves. Open buckets of urine on a factory floor where sterile chemicals are made? Mold growing on the walls? Do you find that at commercial or academic chem labs?
posted by 1adam12 at 11:13 AM on June 23, 2013


They are available at a higher cost, just not at the price point you want to pay.

Like a lot of situations, the economics of this are irrelevant because they're being hidden from the consumers. Ask any parent what they'd be willing to pay for a few drops of calcium so their infant child doesn't die.

But, nobody is asking. We have this apparently completely hidden rationing situation going on, leading to patients being completely uninformed about the fact that they'd be better off packing up their loved ones and flying to goddamn Madrid to avoid dying of perfectly preventable malnutrition.

As the article mentions, if people knew what was going on perhaps there'd be a serious effort to challenge the government for proper long-term solutions, like a complete government takeover of the manufacturer of basic fucking salt suspension. Why the fuck do we tolerate a profit motive for these kinds of things, as a society? It's completely insane.
posted by odinsdream at 11:16 AM on June 23, 2013 [7 favorites]


You know what the real issue is, I think? That for some reason, someone, somewhere, has made the decision that they aren't willing to pay what it takes to make these nutrients profitable.

I'm not sure who that is or why the decision was made, but there you go. There's clearly a medical demand for these products. But somehow there's no financial demand for them.

I point the finger at the fact that patients no longer have any substantive say in the economics of their care. Patients have no idea what a particular procedure, drug, or piece of equipment costs, and quite frequently they're no worse off than the people providing their care. It's sort of a worst of both worlds situation. With single-payer, patients have even less control over their care, but at least they don't get stuck with the bill. In a cash-only system, patients would have incredibly fine control over the care they received, and would indeed probably wind up paying a lot less, but we'd necessarily cut a lot of people out of the system. But now, we've got a lot of people with minimal access to health care, and even those people who do have access can't exert any meaningful control over the care they do receive. If you tried to invent an inefficient, obfuscatory, opaque system for health care, you'd come up with something like we have here.

Why the fuck do we tolerate a profit motive for these kinds of things, as a society? It's completely insane.

Because the idea that we can do whatever we want without considering what things actually cost is equally insane.
posted by valkyryn at 11:18 AM on June 23, 2013 [1 favorite]


> Because the idea that we can do whatever we want without considering what things actually cost is equally insane.

Blatant straw man. No one has proposed this or anything like this.

In this specific case, "what things actually cost" is really tiny - at least, they're able to deliver exactly the same substances, even better in some cases, for pennies in Europe.
posted by lupus_yonderboy at 11:26 AM on June 23, 2013 [2 favorites]


What was the process that resulted in warning letters, rather than something more effective and in the public interest?

I'm pretty comfortable assuming that, like pretty much everything else that's been going on in the regulatory sphere for a while now, there was a lot of involvement from industry-funded lobbyists. And that is regulatory capture.


What "more effective" interventions did you have in mind? It's not like these letters were just brushed off, in some cases the manufacturer immediately took the line out of service until the problems could be fixed.

The FDA has also gone out of their way to try and prevent these warning letters from causing shortages, but the manufacturers don't want to make defective products either and if they can't solve the problem trivially they'll still shut the line down.

There are plenty of excellent examples of regulatory capture but this just isn't one of them.

Why the fuck do we tolerate a profit motive for these kinds of things, as a society? It's completely insane.

Why not? Healthcare provision may be provided (in one way or another) as a public service in most European countries but pharmaceutical manufacturing isn't and drugs are purchased from companies that are operated to make a profit.
posted by atrazine at 11:27 AM on June 23, 2013 [1 favorite]



As the article mentions, if people knew what was going on perhaps there'd be a serious effort to challenge the government for proper long-term solutions, like a complete government takeover of the manufacturer of basic fucking salt suspension. Why the fuck do we tolerate a profit motive for these kinds of things, as a society? It's completely insane.


What's completely insane isn't that we assign these tasks to for-profit corporations. It's that we then place those corporations under incentives towards just-in-time management, with no redundancy, and get aghast when those corporations obey those incentives.

Newsflash folks: not every country out there drives its native corporations in that direction. The European emphasis on value-added-taxation means among other things, a far lower drive towards these fragile supply lines. It costs them money to stockpile goods, since warehousing always costs money, but they don't pay taxes to boot on it.
posted by ocschwar at 11:29 AM on June 23, 2013 [1 favorite]


What was the process that resulted in warning letters, rather than something more effective and in the public interest?

I'm pretty comfortable assuming that, like pretty much everything else that's been going on in the regulatory sphere for a while now, there was a lot of involvement from industry-funded lobbyists. And that is regulatory capture.


I think you're misunderstanding FDA warning letters. They are very clearly driven by obvious, simple-to-understand violations. Take a look for yourself. Here's one from 2010 advising a non-US manufacturer of parenteral products that they have failed to, among other things: ensure they're using purified water even though they were originally warned about it in 2003. Also, the fact that the company apparently hasn't bothered to test their shit for three years:
For example, your firm has not collected or tested a batch of (b)(4) API (active pharmaceutical ingredient) in the last three years. At least one batch per year of API should be tested as part of an ongoing stability program.
This is not a case of over-burdensome regulation. The FDA may do a shit job at certain things, but this is not what's going on, in this particular case. If you think otherwise, feel free to provide a citation from the FDA's warning letters. They're all published right there for you to take a look.
posted by odinsdream at 11:30 AM on June 23, 2013 [6 favorites]


Socialism isn't the answer for this one.

Even if there are plenty of nutrients in Canada (I don't know the status of that), there aren't enough staff to administer them. Let me tell you a little story. My husband was ill and not absorbing nutrients. Doctor called for TPN. Took a day to find a nurse to place the PICC line. However the TPN nurse called in sick, so it would have been three days before they would even start the TPN. It was supposed to be TPN to keep my husband from starving before surgery. His surgery was getting delayed as there were not enough surgeons/nurses/tables to put him on the operating table for 4 days (to be fair he was bumped by cancer patients and it was a long weekend).

It was a dangerous wait. If he had waited much longer before TPN or surgery he would have been too weak for surgery. He was probably closer to death than I cared to think about. The surgeon got him on the table first before they started TPN.

The only benefit I saw to having the PICC line placed was that there was a good place to dump the saline after surgery after the student nurse attending him after surgery placed his line intra-muscular, thus ballooning his arm full of saline for two days before anybody noticed. This was at one of the best hospitals for gastrointestinal surgery in Canada.

Yeah sure it is bad that the babies are starving in the NICU. But if you have ever spent time in a gastrointestinal unit you should see the adults on TPN. It's scary. A bunch of hollowed out yellow/gray skeletons shuffling about in and out of hospital for years. I guess it's OK to starve them too because they only wish they were dead. This is a tragedy I wish I knew how to fix.

For more info on quality of life on TPN check out The man who couldn't eat. Now imagine what would have happened to that guy without nutrients. He would have been dead and so would many others.
posted by crazycanuck at 11:52 AM on June 23, 2013 [1 favorite]


I point the finger at the fact that patients no longer have any substantive say in the economics of their care. Patients have no idea what a particular procedure, drug, or piece of equipment costs, and quite frequently they're no worse off than the people providing their care. It's sort of a worst of both worlds situation. With single-payer, patients have even less control over their care, but at least they don't get stuck with the bill. In a cash-only system, patients would have incredibly fine control over the care they received, and would indeed probably wind up paying a lot less, but we'd necessarily cut a lot of people out of the system.

I sympathize with this position and I've thought about it a lot. I think it is a big, big problem that no one on the consumer end knows what things cost. I can't even tell you what my services cost. It's a big problem that there's a giant industry that stands between suppliers and consumers to obfuscate prices, make decisions for people and skim a percentage off the top that is greater than the profit of the suppliers, and greater than the annual rise in health care expenditures.

For a large number of reasons, Americans of the U.S. variety have made it clear over and over again they don't want a system where money changes hands between them and their health care provider and the situation in the NICU is a great example why this would be problematic. Every day of a 24 week preemie's life, there are literally hundreds of purchasing decisions made and there is no way an emotionally exhausted consumer can make those purchasing decisions in a manner that positively affects the health care market.

It really is an argument for a rational, compassionate, benevolent and accountable top-down decision making process.
posted by Slarty Bartfast at 11:57 AM on June 23, 2013 [6 favorites]


So if this happened to the NHS in the UK, there'd be huge aggressive top story headlines on the front page of every major news outlet, especially the rightwing ones. But this huge story seems under reported in the US...
posted by Bwithh at 11:59 AM on June 23, 2013 [3 favorites]


Bacterial life finds a way.

Clever germ...
posted by Riki tiki at 12:00 PM on June 23, 2013 [2 favorites]


But in Canada it's socialism! And you might have to wait for care!

Heh. One thing I don't think gets brought up in response to this often enough is that the waits are for certain procedures in certain places at certain times. I highly doubt all people in the US have access to the exact procedure they need at their local hospital at all times with no waiting ever.
posted by Hoopo at 12:05 PM on June 23, 2013 [4 favorites]


No "bad" guy but plenty of unmotivated ones.

Can I nominate as "bad guys" people who fight hard to keep insurance for and delivery of medical care as profitable as possible? I know they're not right there when things get hard, but that's the skill they exercise to earn their high salaries.
posted by benito.strauss at 12:15 PM on June 23, 2013 [1 favorite]


Isn't this when we nationalize the manufacturing of life-critical supplements so that we don't have people dying of malnutrition due to vitamin shortages.
posted by Lord_Pall at 12:19 PM on June 23, 2013 [1 favorite]


Isn't this when we nationalize the manufacturing of life-critical supplements so that we don't have people dying of malnutrition due to vitamin shortages.


No, because then we'll have the same problem when the sequester hits the Tactical Injectable Nutrients Reserve, or when a congressional committee decides on a 20% budget cut for the NIH and demands the NIH Just Get It Done.

There is an inherent conflict between a production process being efficent and the same process being resilient against interruption. The government is just as confronted with that conflict as the private sector.
posted by ocschwar at 12:22 PM on June 23, 2013 [3 favorites]


I highly doubt all people in the US have access to the exact procedure they need at their local hospital at all times with no waiting ever.

It's weird: one can wait weeks to see a specialist and yet the same thing happens outside the US and everyone screams socialism.
posted by Blazecock Pileon at 12:47 PM on June 23, 2013 [9 favorites]


A couple of thoughts:

First, my understanding is that preemie births are up. So it seems there is something else going on here which is not being addressed. Keeping these babies in the womb longer would be the better solution.

Second, salt and water and a lot of other things will absorb through the skin. When administered that way, you do not need to be so picky about whether it has particulate matter in it. You can buy sea salt for the bath cheaper than you can food grade sea salt. The main difference: It is more likely to contain sand and feathers. No big. Your skin will keep that stuff out and just absorb the good stuff it needs.

It boggles my mind that people insist on making this unnecessarily difficult. But they choose to do so when it is their own body in their own home and they actually could choose to do the simple, cheap, effective thing. I see no hope in getting hospitals to change amy time soon.

Perhaps something I shouldn't bother to say here and should just blog about and perhaps will.
posted by Michele in California at 2:07 PM on June 23, 2013


I find it appalling that people in this thread could even countenance the argument that government regulation is at fault here when this shortage is only occurring in the United States, which has nearly no central regulation at all.

Like everything else in America these days, the corporations are calling the shots and they simply give no fucks, because they're not accountable to anyone. It's classic fuck you politics where these drug manufacturers got all bent out of shape they can't continue to sell overpriced salt water to hospitals at 1000x markup without cleaning the factory or filtering out glass shards and lead, so they're taking their toys and going home to deliberately create an artificial shortage so the FDA is completely powerless to do anything at all the next time someone has a stroke because there was a cockroach wing in their propofol. Furthermore, the idea that sterile IV electrolytes are expensive or unnecessary is the sort of thing that gives me a crippling migraine.

Closing a plant for years because the FDA sent you a strongly worded letter is over regulation? Call me when the FDA closes the plant and people go to jail for criminal negligence. Open containers of urine in a sterile plant...and the FDA is unable to assess any penalties for violations. That's the opposite of regulation.

I love how corporate irresponsibility in the pursuit of profit can literally result in dead babies and the first instinct of people is to jump at the chance to blame government regulation rather than maybe consider the current system is irredeemably broken.

Again, drug manufacturers in America exist in a special bubble where profits have to be thousands or hundreds of thousands of times greater than any other country in the world because reasons. Personally if I was in charge of a pharmaceutical company I would consider maybe losing that advertising budget that routinely accounts for up to a third of expenditures and maybe focus on enjoying their record high profit margins quarter after quarter after quarter.

This whole thing is a hit piece, attempting to frame an entirely powerless agency as responsible for a situation artificially created by the very people seeking to remove all regulation, at any cost. Or did you really think that shipping propofol in from Sweden was really going to be cheaper for the hospital, for the patient, than making it here?

This is about corporate interests holding America hostage again, pretty much the overarching theme of the last 10 years.
posted by hobo gitano de queretaro at 2:23 PM on June 23, 2013 [23 favorites]


A new report on motherhood paints a devastating portrait of social conditions for poor women and their babies around the world. In both developing and industrialized countries, the first month of birth is the most dangerous of an infant’s life.

“State of the World’s Mothers,” a report from the humanitarian organization Save the Children, released May 7, finds more than three million babies die within the first month of their birth. A staggering one million infants die on the day they are born.

The US has by far the highest first-day death rate in the industrialized world. The report states, “An estimated 11,300 newborn babies die each year in the United States on the day they are born. This is 50 percent more first-day deaths than all other industrialized countries combined.” The 33 other industrialized countries for which data was collected recorded a combined total of 7,500 first-day deaths each year.

The report, done in conjunction with the London School of Hygiene & Tropical Medicine, is the first global analysis of newborn day-of-death data. Its findings are an indictment of social inequality created by the capitalist system worldwide. Because the report analyzes 2011 statistics, it is likely that the ensuing year and a half have seen a worsening of these indices.

Within wealthy countries, a widening section of the working class are subject to poor living standards and extreme disparities in health care. Millions of Americans as a result fare little better—and in some aspects worse—than their counterparts in some of the poorest countries in the world.

posted by infini at 2:38 PM on June 23, 2013 [6 favorites]


First, my understanding is that preemie births are up. So it seems there is something else going on here which is not being addressed. Keeping these babies in the womb longer would be the better solution.

Every possible avenue will already have been tried before those babies are born prematurely. Extreme premature birth is a medical crisis, which doctors will have done everything they can to prevent. Premature birth is only an option when continuing the pregnancy endangers the life of the mother, or when it's impossible to stop labour. No doctor wants a baby to be born too early.

Second, salt and water and a lot of other things will absorb through the skin. When administered that way, you do not need to be so picky about whether it has particulate matter in it.

Nothing against you personally, Michele, but it amazes me the number of people here who are second-guessing medical protocols. Make a bucket of saline in the lab and run it into the veins of incredibly delicate patients? Put them in a salt bath to absorb nutrients? It doesn't work like that.
posted by jokeefe at 2:55 PM on June 23, 2013 [9 favorites]


There are things for which the incentives of capitalism break down. Capitalism is a method of distributing resources. A resource's import is measured in its price, which comes from both demand and supply. Everything ultimately ends up getting measured in money. And despite some grousing (sometimes by me!), it generally does okay at this.

Except that money isn't always a good measure. In places where other, asymptotic values come into play, like human life, the use of money as a valuer breaks down. It becomes a case of the map diverging from the terrain; the system forgets that which it was created (or, at least, what we continue to maintain it) to do, and goes off chasing money. It shouldn't ever be forgotten that money is a means to ends, a virtual good created in order to help distribute actual resources.

But this is nothing new. In cases like these it's the job of government to take up the slack by providing financial incentives itself, like by subsidizing manufacturing.
posted by JHarris at 2:59 PM on June 23, 2013 [1 favorite]


Nothing against you personally, Michele, but it amazes me the number of people here who are second-guessing medical protocols. Make a bucket of saline in the lab and run it into the veins of incredibly delicate patients? Put them in a salt bath to absorb nutrients? It doesn't work like that. posted by jokeefe 8 minutes ago [+]

It absolutely does work like that. It works extremely effectively like that. I know it to be true because it is a daily part of managing my deadly medical condition that impairs gut (and lung) function and is commonly treated with prescriptions for sterile nebulized saline solution.

But I should know better by now than to try to discuss that with anyone. Please excuse me for having a bad day and being tired of talking to myself in some internet corner while other people suffer horribly (and essentially unnecessarily). I should, in fact, stick to trying to make such points on an unread blog somewhere.

Further, my point about preemie births is that there is something very wrong culturally that needs to be fixed. High levels of preemie births is not merely a medical issue.
posted by Michele in California at 3:15 PM on June 23, 2013


Further, my point about preemie births is that there is something very wrong culturally that needs to be fixed. High levels of preemie births is not merely a medical issue.

From the report I linked to earlier:
While the report does not analyze disparities among socio-economic groups within wealthy countries, it notes that “newborn and infant mortality are often higher among the poor and racial/ethnic minorities, and populations with high newborn mortality rates also tend to have high first-day death rates. Poor and minority groups also suffer higher burdens of prematurity and low birthweight, which likely lead to first-day deaths in the US and elsewhere.”

One in eight babies in the US are born preterm, or less than 37 weeks gestational age. This is second only to Cyprus for preterm birthrate in the industrialized world, and 131st out of the 176 countries surveyed. Complications of preterm birth are the direct cause of one-third of all newborn deaths in the US.

A major factor behind the high rate of preterm birth in the US is poverty. Tens of millions of Americans live in destitution, including millions of young mothers and their children. Some 16 million children in the US live in “extreme poverty,” in households whose annual income is less than half the official poverty line. Since the onset of the 2008 recession, many social outreach, nutrition, and public health programs serving these women and their babies have been gutted.

This state of affairs has made it more difficult for young poor women to access prenatal, family planning, and general health care. The US has the highest adolescent birthrate in the industrialized world. Teenage mothers are overwhelmingly poor, less educated, and receive less prenatal care than older mothers. They are also more likely to suffer malnutrition and lack transportation and access to information about maternal health. As a result, their children are much more likely to be low-birthweight and premature.

Preterm births present special problems, such as undeveloped lungs and an immature immune system. These conditions require constant and intensive care at quality hospitals. Across the US, hospitals have been cutting such care and raising costs over the past decade. In Philadelphia, for example, which the federal Centers for Disease Control and Prevention ranks as 196th out of 200 urban counties for infant mortality, 15 maternity wards have been closed down. Only six remain open.

The growing ranks of the uninsured and Medicaid recipients have also put the strain on hospitals that receive state reimbursement for services to the poor. As states slash reimbursement rates, hospitals have tightened admissions and scrapped charity care programs. According to reproductive health organization the Guttmacher Institute, one in five US women of childbearing age are uninsured. Another 15 percent are enrolled in Medicaid.
posted by infini at 3:21 PM on June 23, 2013 [7 favorites]


On the other hand, they probably know the keystrokes I used to dig up this report. And how to fundraise for mobiles to save babies in remote rural Africa.
posted by infini at 3:35 PM on June 23, 2013


Thanks infini.
The last stats I saw indicate that most poor Americans are women (and their children) who were solidly middle class until pregnancy, divorce or death of their spouse plunged them into poverty. It is very much a gendered phenomenon in the U.S. and there is something seriously wrong with that.
posted by Michele in California at 3:39 PM on June 23, 2013 [2 favorites]


What's interesting about this is that one of the major drivers behind this shortage seems to be coming from purchase-side price collusion. Generally, shortages tend to be short-term in the absence of external forces, such as price controls, raw material depletion, or unregulated monopolies. In this case, though, it's a group of hospital drug buyers banding together to create a near-monopsony, driving the prices down too far for the suppliers to make a profit high enough to give them the incentive to produce enough supply to meet demand.

Here's what I find to be the most interesting part of all this - price fixing via collusion, when done by a group of sellers, is, with a few very narrowly defined exceptions, illegal here in the US. This situation would seem to be caused by price-fixing by a group of BUYERS, though, which is a situation I don't remember hearing about in the past. I have no idea if the price-fixing section of the Sherman Act would apply here - although considering the consequences of the market failures caused by this collusion (as well-documented here) perhaps it should.

(tl;dr - corporations try to screw other corporations, ordinary families get screwed as a result.)
posted by deadmessenger at 3:58 PM on June 23, 2013 [1 favorite]


Again, drug manufacturers in America exist in a special bubble where profits have to be thousands or hundreds of thousands of times greater than any other country in the world because reasons.

...Where reasons = massive research and development costs, including that for drugs that never make it to market, not to mention liabity costs when early testing fails to predict adverse reactions. Manufacturing modern pharmaceuticals is a small part of the process of making them. I'm not saying we shouldn't overhaul pharmaceutical costs - clearly the current model is broken in many ways (for example, companies skimp on that expensive early testing because sometimes settlements are more profit-friendly). I'm not saying profit isn't an incentive in this shortage, but I am saying that drugs are sometimes expensive for perfectly valid reasons.
posted by maryr at 3:59 PM on June 23, 2013


rough ashlar: "Say, hows that Big Government working out for the capture and retention of phone info/email? Is that Big Government solution solving the problem it is claimed to solve? How much money is being spent to solve that problem?"

We actually have many, many examples of socialized medicine throughout the world, and how it outperforms healthcare in the US by leaps and bounds when it comes to solving these types of issues. We also have a negative example in the US of how not to run healthcare. Making "big government" into a bogeyman is an oversimplification of a problem that demands more thought, and conflating issues is not shedding any light on the conversation.
posted by krinklyfig at 4:00 PM on June 23, 2013 [3 favorites]


In this case, though, it's a group of hospital drug buyers banding together to create a near-monopsony, driving the prices down too far for the suppliers to make a profit high enough to give them the incentive to produce enough supply to meet demand.

Except this is not at all what is happening. The hospitals are willing to pay any price at all, but the manufacturers just don't care. This is a broken supply chain of an essential good that is vital for many thousands of people every year, including the most vulnerable of patients, and there's not even a discussion of what the consequences are going to be for this criminal negligence.

You're reading the article and accepting their conclusions at face value, which includes choice quotes from industry spokespersons. Why would you even consider doing that?

I mean, what other kinds of industry, other than pharmaceuticals, just walk away from profitable sectors of their business simply because they don't involve double or triple digit profit growth?

This is completely broken, and you're directly engaging in victim blaming because that was the easy narrative set up for you in an article, which was most likely bought and paid for by a lobbyist.
posted by hobo gitano de queretaro at 4:05 PM on June 23, 2013


I'm not saying profit isn't an incentive in this shortage, but I am saying that drugs are sometimes expensive for perfectly valid reasons. posted by maryr 1 minute ago [+]

Correct me if I am wrong, but my understanding is that the U.S. essentially foots the bill for pharmaceutical research globally. So drugs are often cheaper in other countries because of that, which means that getting all draconian about U.S. bigpharma profits might result in essentially killing global invention of new drugs.

Things like this do not occur in a vacuum and are rarely simple.
posted by Michele in California at 4:06 PM on June 23, 2013


I don't think that is the case, Michele. If you look into trends in funding research through NIH and other programs at the university level (fwiw I used to work in the tech transfer office at UPitt, a leader in med patents and health science research), you'll find patterns taht show a shift of the burden of funding medical and life science research onto profit making organizations and/or institutions (look up the Bayh Dole act for eg). Whereas my current collaborators are from a leading European life sciences uni where the research funding and subsequent output is treated as a public good rather than a monetizable resource for either academia or pharma or life sciences startup.

This is a simplified generalized version of waht happens globally (eg more complicated would be to start looking beyond US/EU towards how research funding in life sciences is set up in Asia both South and East as well as SouthEast etc) and what is happening in trends simply to illustrate a point because your comment assumes that ONLY the US does any research in this area.
posted by infini at 4:18 PM on June 23, 2013 [2 favorites]


No, I am not assuming that. I have left most of the medical lists I used to read. I no longer bother to keep up. I do not think research only happens in the U.S. But when I used to read articles and discussions regularly, it did seem the U.S. funded a disproportionate share. You do not have to be the sole source of funding to serve as a global bottleneck.

But I no longer bother to try to participate in such things. I basically quit a few months ago.

Thanks for replying.
posted by Michele in California at 4:23 PM on June 23, 2013


With all respect to Maryr, whom I understand is an actual scientist with actual lab experience, there is no reason why any pharmacist should not be able to make up a safe solution of calcium gluconate. None at all. This is the sort of thing which every MD used to do back in the day; it's still part of their education (at least in Australia) and it is certainly part of every pharmacist's education. I'm not talking about a packaged solution that is necessarily shelf-stable or guaranteed to be sterile for the next ten years; I'm talking about enough to save a child's life. Yes, ideally they could just grab a packet off the shelf, but here's what they're doing already:
  1. Filtering electrolytes from an adult dose;
  2. Drawing multiple doses from single-dose containers;
  3. Buying gray market supplies, which they believe may be badly-stored, counterfeit, or diluted.
Every risk that might occur in a lab is already present. In fact the practices they describe are much more dangerous than using a solution made from sterile water and a sterile chemical, and placed in a sterile container shortly before use. Yes, you'd need some lab space and a pharmacist to do this in a safe and ethical manner, but you could build a sufficiently-large laboratory in a closet.
posted by Joe in Australia at 4:36 PM on June 23, 2013 [3 favorites]


Wait, the head of the FDA gets to wear a BDU (battle-dress uniform)?

Well, no, that's the shapeless kind with camo and velcro. What she's wearing is dress blues. (The current PHS uniforms are pretty much somewhat outdated Navy uniforms.)

Also, the head of the FDA is a civilian commissioner. This is just somebody from the USPHS (also part of Health and Human Services) who's seconded to the FDA in some form (I'm not entirely sure how the org chart works) -- but yes, people in the FDA can be rear admirals. Nothing new, really -- you knew the Surgeon General wears a uniform, right?

They're no Cap'n Crunch.

It's an official uniformed service under US law, but only one of two that are noncombatant (the other is the NOAA Corps).
posted by dhartung at 5:19 PM on June 23, 2013


Having been a preemie in a Washington hospital (now turned into luxury condos and a Trader Joe's,) this hits hard. With twins born five weeks early and my mother recovering from a month of bed rest, I don't think they would have turned to sea salt sand baths or ad hoc solutions mixed up in unlicensed college labs.
posted by jetlagaddict at 7:01 PM on June 23, 2013


Joe - I'm a lot more OK with the idea of pharmacists making these drugs than I am random scientists in research labs. I'm not saying we can't do the math. I'm not saying we can't keep things sterile. I'm saying it's inappropriate to be preparing intravenous solutions in environments where E. coli & yeast are handled routinely on purpose.
posted by maryr at 7:27 PM on June 23, 2013 [3 favorites]


I don't think they would have turned to sea salt sand baths or ad hoc solutions mixed up in unlicensed college labs. posted by jetlagaddict at 7:01 PM on June 23 [+] [!]

Oh, no worries. I am sure they still won't -- even if it would work and save lives.
posted by Michele in California at 7:41 PM on June 23, 2013


valkyryn: "You know what the real issue is, I think? That for some reason, someone, somewhere, has made the decision that they aren't willing to pay what it takes to make these nutrients profitable. "

Fortunately, the article talks about the people who make that decision:
Other experts blame the shortages on GPOs. Hospitals typically don’t purchase drugs directly from manufacturers. Instead, hundreds of hospitals band together and work with a GPO, which bids manufacturers down to the lowest price possible. Because these consortiums have driven the prices of generic injectables so low, some say, manufacturing them isn’t profitable.
...
Childs disputes the idea that GPOs have the power to suppress prices to the point where production is no longer viable—or that they would want to. “It’s a nutty accusation,” he says. “We are going to do everything we can to drive market competition, but ultimately we want a healthy market.”


I'm curious how a purchasing department is driving supplier profits negative. Like, some manufacturer had to agree to deliver a large volume of drugs at a price that "isn't profitable." If they can't deliver, it should be simple to renegotiate a price that suppliers are willing to supply at. Given how expensive/inefficient NICU care is in general, I don't see why injections are the sole razor thin margin component.

The best I can come up with is that there are very few manufacturers, and it wouldn't be hard for a large pharmacorp to pay generic manufacturers to stop making a low margin product. The problem with even this cynical explanation is that I doubt there's an on-patent alternative for most of these injections.
posted by pwnguin at 7:47 PM on June 23, 2013


If you look into trends in funding research through NIH and other programs at the university level ... you'll find patterns that show a shift of the burden of funding medical and life science research onto profit making organizations and/or institutions. Whereas my current collaborators are from a leading European life sciences uni where the research funding and subsequent output is treated as a public good rather than a monetizable resource for either academia or pharma or life sciences startup. - [1]

Yes, that seems like a pretty good explaination of reasons drugs are often more expensive in the US. One, that we shift the some of responsibility to business and those businesses need to make a profit. And two, that in other countries, receiving research funds can lead to their governments having cheaper access to the output, but of course not to the US having cheaper drugs. I can't tell if we are agreeing or disagreeing here. It isn't as if American companies don't benefit from overseas research (not to mention manpower). But it isn't as if the rest of the world doesn't benefit from the sizeable academic and private research sector in the US.

The US is still (as of 2009) the largest single R&D performing country (31%) in the world. The next largest nation is China at 12%. That said, the US still runs a negative trade balance in pharmaceuticals. [1] ...To be honest, I'm not entirely sure what this means. Clearly I'm missing pieces. But something seems broken there.

-
1: Slightly edited quote from infini- I removed parentheticals. I don't think this altered meaning or context, but I'm already footnoting, so I wanted to acknowledge the change.

2: Data from this report, of which admittedly is only a summary, but that's about as in depth as I'm going to go because it's Sunday night and really, I was trying to just find a damn pie chart with this info somewhere
posted by maryr at 7:59 PM on June 23, 2013 [2 favorites]


I'm curious how a purchasing department is driving supplier profits negative.

pwnguin, an argument I've heard before is that making a razor thin profit from a huge buyer is better than being squeezed out of the market altogether. In that case I believe the buyer was Walmart and the product was lightbulbs and the result was that manufacturers were forced to start making more CFLs. I do not have a source for this anecdote.

Alternately, the saline solutions could be a loss-leader. Maybe the pharma/supplier agreed to set a low contract price for those in order to be able to be the sole supplier of something more profitable. Eventually they chose to stop manufacturing the product they were losing money on and thus got out of that part of the contract. (Example: whatever is on sale at your grocery store this week. The sale on orange juice gets you in the door but they jack up the price of milk and eggs and make up the difference.)

Neither of those approaches really work unless the buyer has some sort of huge percentage of the manufacturer's market, but they are possible.

And now I feel like I'm threadsitting and I'm not really *that* committed to this topic (honestly, I agree with ocschwar's comment on supply chain interruption here), so I'll take a break. Sorry.
posted by maryr at 8:11 PM on June 23, 2013 [1 favorite]


At some facilities, the agency found [...] open containers of urine
Why is that a thing?

There is no world in which that should be a thing.
posted by vibratory manner of working at 11:10 PM on June 23, 2013


Maybe it was just a half empty bottle of Mountain Dew. Could you tell the difference?
posted by pwnguin at 11:12 PM on June 23, 2013


pwnguin: "Maybe it was just a half empty bottle of Mountain Dew. Could you tell the difference?"

The smell.

And, as for the rest of this, all I can say is...

What

The

Fuck?

There is no rational reason that can explain this situation to me.
posted by Samizdata at 11:39 PM on June 23, 2013


...Where reasons = massive research and development costs, including that for drugs that never make it to market, not to mention liabity costs when early testing fails to predict adverse reactions. Manufacturing modern pharmaceuticals is a small part of the process of making them. I'm not saying we shouldn't overhaul pharmaceutical costs - clearly the current model is broken in many ways (for example, companies skimp on that expensive early testing because sometimes settlements are more profit-friendly). I'm not saying profit isn't an incentive in this shortage, but I am saying that drugs are sometimes expensive for perfectly valid reasons.

Why are we discussing R&D costs for standard generics?

Personally if I was in charge of a pharmaceutical company I would consider maybe losing that advertising budget that routinely accounts for up to a third of expenditures and maybe focus on enjoying their record high profit margins quarter after quarter after quarter.

1) I doubt that the manufacturers of generics spend as much as that on advertising.
2) Those pharma companies that do spend a lot on advertising and sales do so to make more money. If you cut them, your record high profit margins would not last long.
3) Record high profit margins? In the pharmaceutical industry? Not in this decade.
posted by atrazine at 11:40 PM on June 23, 2013


I'm curious how a purchasing department is driving supplier profits negative.

pwnguin, an argument I've heard before is that making a razor thin profit from a huge buyer is better than being squeezed out of the market altogether. In that case I believe the buyer was Walmart and the product was lightbulbs and the result was that manufacturers were forced to start making more CFLs. I do not have a source for this anecdote.


Yes, exactly. I came in here to say Walmart and my example was going to be an American ceiling fan manufacturer driven out of business because of being set a lowballed price by Walmart. Chinese mfrs were offering discounted or subsidized pricing and no rational mfr was able to meet them. This is a thing and there's lots of stories out there from 2006-2007 about this happening.

maryr - I, too, was barely coherent late on a Sunday but I suspect we aren't disagreeing that something is broken in the model or process.
posted by infini at 11:59 PM on June 23, 2013


I was a three-pound preemie who required intravenous nutrition. That article gave me a feeling akin to vertigo.

I am so fortunate that I was born in a first-world country, these great United St- oh, wait.
posted by easy, lucky, free at 12:56 AM on June 24, 2013 [1 favorite]


infini: "Yes, exactly. I came in here to say Walmart and my example was going to be an American ceiling fan manufacturer driven out of business because of being set a lowballed price by Walmart."

It is a thing, but it's a different thing than what we're discussing. Ceiling fans aren't basically prohibited from importation, to my knowledge. I feel it's a pretty long stretch to say that hospital GPOs dictated a price no domestic supplier could fullfill just to twist FDA's arm into temporarily lifting import restrictions on life saving injections.

Reviewing the key facts, I think I believe the FDA's argument is that it's a supply shock. Their database doesn't make the situation clear, publishing "initial postings" that makes things look slightly worse than reality. If a particular concentration (I guess?) is unavailable from a single manufacturer, that seems to be enough to make the list. There are listings that say the medication is discontinued from one manufacturer while listing several other manufacturers supplies as 'available'. Useful I suppose for practicioners needing to restock.

I'm not sure why other manufacturers aren't jumping to bring Trace Elements injections to market; perhaps renegotiating higher prices would be difficult and would disrupt existing contracts?
posted by pwnguin at 12:58 AM on June 24, 2013 [1 favorite]




I was a three-pound preemie who required intravenous nutrition. That article gave me a feeling akin to vertigo.

I am so fortunate that I was born in a first-world country, these great United St- oh, wait.


Be thankful if you aren't diabetic. This company in Denmark is of literally vital importance to every diabetic person on the planet:

http://en.wikipedia.org/wiki/Novo_Nordisk

One truck bomb in one parking lot in Denmark would cause hundreds of thousands of diabetics to die.

This is not ONLY an American problem. And it's not really a private/public sector problem.
posted by ocschwar at 6:26 AM on June 24, 2013 [1 favorite]


Given Novo Nordisk's significant operations in Shanghai, one continent might not be enough, ocshwar
posted by infini at 6:31 AM on June 24, 2013 [1 favorite]


I am googling like bad, but NN's facilities were a commonly mentioned as an attractive target for potential terrorists-with-brains post 9/11. (Thank FSM no such terrorists have come up yet). In particular one production facilty in DK proper.
posted by ocschwar at 7:32 AM on June 24, 2013


Some discussion by diabetics in 2012:

http://www.tudiabetes.org/forum/topics/insulin-supply-chain?xg_source=activity

The original article I read doesn't show up. (Why can't Neocons just add the words "Leo Strauss" to the bottom of every article they write? Would make it so much easier to find it 7 years later.)
posted by ocschwar at 7:40 AM on June 24, 2013


(Why can't Neocons just add the words "Leo Strauss" to the bottom of every article they write? Would make it so much easier to find it 7 years later.)

Deliberate esotericism.
posted by atrazine at 8:54 AM on June 24, 2013


I think its because the way the english language interwebs/media portray things, these people don't realize how large a multinational Novo Nordisk actually is (and other such companies). Sorry to bring that up again and cause pain in this thread. From their wikipedia page:

Company headquarters are in Denmark, with production facilities in seven countries, and affiliates or offices in 76 countries. It employed approximately 29,000 people globally as of Q4 2009, and marketed its products in 179 countries. It is the largest publicly traded company in the Nordic countries by market capitalization.[3]

It really must be a neocon thing. Is Heartland Institute part of that gang? (curiously asking for yet another such type mispositioning)
posted by infini at 10:19 AM on June 24, 2013


Company headquarters are in Denmark, with production facilities in seven countries

Production facilities for every product? I hope so. 7 years ago I read that was not the case.
posted by ocschwar at 10:20 AM on June 24, 2013


Its from your link. And you're right, it may not have been the case 7 years ago, I think iirc* they really got active in China about 5 or so years ago.

*(long complicated story about the design of their packaging and designers in CPH bla bla bla)
posted by infini at 10:22 AM on June 24, 2013


For what it's worth, I'm looking at a box of Levemir and another of Novorapid and they both say "Made in Brazil" (I'm in Australia).
posted by flabdablet at 10:27 AM on June 24, 2013


I read this when it first came out, and I've studied pharma & biotech in some detail as a grad student - both from the regulatory side and the commercial side, so I'm frustratingly aware of how slow things move in this arena. The "no villains or several" description is pretty damn familiar, but reading this still made me sick to my stomach.

My mind keeps coming back to the title of the article, and how the gut reaction to how fucked up this situation is leads us all back to wanting to do a complete overhaul of healthcare delivery, or economics, or drug manufacturing in the U.S. Which I'm in favor of (both shedding light onto and changing), but in the meantime, here is a situation demanding stopgap measures, not just calls for reform.

It took until the last page of the article to mention the CDC strategic stockpiles, which I was almost shouting at my screen about by page 3 of this article. I mean, the U.S. has a goddamn helium reserve still. Are you telling me we can't stockpile a few more lactated ringers?

For that matter, it's not like parenteral nutrition solutions are still under patent protection or regulatory exclusivity. And as pointed out earlier in the thread, as things you can make in a GLP environment go, these are pretty easy. So with no IP or regulatory protection, one natural reaction is okay, why isn't anyone else coming out with an alternate supply to fill the domestic market demand? Seems like a great opportunity for someone to set up a contract manufacturing facility aimed squarely at short-supply drugs, and for FDA to accelerate the inspection and approval process that entity to manufacture & sell those drugs to hospitals, who clearly have a desperate & urgent need.

But even if you set aside the pricing issues and the challenge of getting a facility up and running quickly, you still need that FDA approval. And since you're not making a new drug, you have to go through the abbreviated new drug application (ANDA), a process with a current (2012) median time to approval of 34 months. FDA does have a mechanisms for speeding up the approval of new drugs where there's an urgent or unmet medical need, but for drugs that are already on market, you're SOL. If a new manufacturer is interested in starting to manufacture and sell zinc chloride to fill the gap from Hospira's production line, there's no formalized pathway for getting FDA to look at that approval more quickly. And what manufacturer is going to look at the pricing margins for lactated ringers plus that 34-month approval timeline and think this is an business worth getting into? By the time you even get approval to start making and selling your product, the shortage may be solved, and the demand evaporate.

So instead of a stockpile of this or that, I guess I really wish the government had some flexible manufacturing capabilities that could be deployed in national emergencies. That's my strategic healthcare pony. (Or one of them, anyway.)

Anyhow. Depressing. But I'm glad to hear they've relaxed the importing restrictions.
posted by deludingmyself at 2:23 PM on June 24, 2013 [1 favorite]


Top Medicare Prescribers Rake In Speaking Fees From Drugmakers

ProPublica's analysis marks the first time anyone has matched payment data made public by drug companies with physician prescribing records from the Medicare drug program, which covers about 1 out of every 4 prescriptions in the U.S.


Maybe that and all the lawsuits mentioned in the article are also among the reasons why drug costs are so high or among the other reasons for supply chain inefficiencies.

Yes, agreed, Walmart was inappropriate in my earlier comment - I confess to hazarding a guess by analogy
posted by infini at 6:53 AM on June 25, 2013


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