Drug Shortages are Killing

by on July 18, 2013 at 7:34 am in Law, Medicine | Permalink

The shortages of injectable drugs that I have been writing about since 2011 (e.g. here and here) are continuing and they are extending to ordinary nutrients needed by premature babies:

Because of nationwide shortages, Washington hospitals are rationing, hoarding, and bartering critical nutrients premature babies and other patients need to survive.

..At the time of this writing—some shortages come and go by the week—Atticus’s hospital is low on intravenous calcium, zinc, lipids (fat), protein, magnesium, multivitamins, and sodium phosphate; it’s completely out of copper, selenium, chromium, potassium phosphate, vitamin A, and potassium acetate. And so are many other hospitals and pharmacies in the country, leading to complications usually seen only in the developing world, if ever.

The article in the Washingtonian covers problems with GMP regulations and the FDA, as I did earlier. The article also makes the following point. Many of these products, especially the simpler ones, are available in Europe but it is illegal to import them to the United States.

Many doctors are pinning their immediate hopes on Congress’s forcing the FDA to form a global pipeline to import an emergency supply. “I have friends in other countries who could get me some, but that would be illegal,” one doctor says. In fact, pharmacists note that the phosphorous Europe uses is a better product than that in the US because it’s organic and doesn’t interact with calcium in the PN, meaning more phosphorous could be included in the IV bag.

When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.

“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all.

Hat tip: Kurt Schuler.

anon July 18, 2013 at 8:02 am

Peak injectable drugs? Peak vaccines?

Unfortunately, this is a reflection of the intellectual lightweights running the country.

See
http://www.volokh.com/2013/07/17/political-ignorance-in-congress

Turkey Vulture July 18, 2013 at 10:35 am

The vaccine industry is a mess of absurdly high barriers to entry, no path to genericization, and anti-competitive conduct. And at least two of those criticisms apply to Pharma generally.

Andrew' July 18, 2013 at 11:00 am

The number of vaccines exploded when the government shielded them from liability and mandated their demand. This is what I have identified and called the process of government anarchization through government dysregulation.

mofo. July 18, 2013 at 8:18 am

If you question the FDA’s effectiveness, then you must want to live in Somalia.

Marie July 18, 2013 at 8:28 am

And the viruses win. . . . .

Andrew C July 18, 2013 at 9:07 am

The question here isn’t whether to have a drug regulation body at all, but what it should do. Testing for safety is wonderful and something we should be doing. Countries in Europe seem to do fine without testing for efficacy, and they seem to have better health outcomes than us so maybe we should mimic them and regulate less there. Setting Stalinist production quotas for drugs is incredibly stupid and something that we should stop immediately.

Marie July 18, 2013 at 9:21 am

Agreed. I was making a bad “the terrorists win” joke.

Andrew' July 18, 2013 at 9:24 am

I got it ;)

Clinton July 18, 2013 at 12:35 pm

“If you question the FDA’s effectiveness,”

Then you’re in good company! So did Herbert L. Ley, Jr., director of the FDA.

“then you must want to live in Somalia.”

Isn’t that where the U.S. bombed pharmaceutical factories which were accused (without evidence) of being chemical weapon factories, thus depriving the citizens of necessary vaccines, and killing tens of thousands of them?

Roy July 18, 2013 at 1:24 pm

No that was Sudan. But that was 15 years ago, and who cares about, or even remembers, the Lewinski business now?

JWatts July 18, 2013 at 5:15 pm

Sometimes you have to wag the dog.

prior_approval July 18, 2013 at 8:19 am

Well, it might not be precisely because of the burden of Good Manufacturing Practice regulation -

‘The House committee report doesn’t mention the reasons the FDA cautioned the manufacturers. At some facilities, the agency found mold on the walls, open containers of urine, and metal chips in vials—serious problems, to be sure. An examination of FDA inspection letters reveals dozens of additional infractions. But the report notes that a review of the violations “did not find any instances where the shutdown was associated with reports of drugs harming customers.”’

See, we should just leave the manufacturers alone, because things like open containers of urine in a factory and metal chips in vials are the sorts of things that show the market needs even more freedom to profit.

And of course, the EU follows GMP. Which, just like having essentially universal health care, leads to the following anecdote, compared to what many Americans consider to be the best health care system in the world –

‘When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.

“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all.

The only shortage Sáenz de Pipaón could recall in Spain occurred two years ago when a Canadian factory stopped making trace elements. His hospital pharmacy immediately secured the product from a Swedish manufacturer and had it for patients within two days.’

Talk about waiting times in a regulated market for health care, compared to American free market style results.

mb July 18, 2013 at 8:22 am

See, we should just leave the manufacturers alone, because things like open containers of urine in a factory and metal chips in vials are the sorts of things that show the market needs even more freedom to profit.

Did the FDA stop this? Are there speeding laws? Do you speed?

Regulations do not stop anything, please grow up.

Andrew' July 18, 2013 at 8:29 am

“Regulations do not stop anything”

Well, regulations have effects. Those effects are different from their marketing. Study them.

mb July 18, 2013 at 8:35 am

regulations can punish people that break the regulations. Prevention not so much. same as any law.

Andrew' July 18, 2013 at 8:57 am

PA, I don’t think you understand what GMP is all about. It doesn’t say you can’t have open bottles of urine. It just says if you have open bottles of urine your procedures should say so.

Andrew' July 18, 2013 at 9:00 am

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

“GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.”

Thinking that we can have an economy and then for everyone in the economy have a Federal agent sitting over their shoulder who knows even better how to do that person’s job is the insane notion that keeps getting us into trouble. GMP will have little to do with shortages if it is done properly or it could have a lot to do with shortages if wrongheaded oversight involves micromanagement.

Andrew' July 18, 2013 at 9:26 am

In short: a correct quality system is about precision, not accuracy. It is about doing things the same way every time so you are reasonably sure that what you got is what you think you got. That is why a quality system is (almost) justifiably AUDITED (not controlled) centrally.

The accuracy part is much more Hayekian in nature.

mb July 18, 2013 at 10:58 am

Let’s look at a dynamic industry, mobile phones. Do you think they do it the same way every time? Do you think their quality suffers? The old AT&T almost certainly did it the same way every time, would we be better off with that? Processes improve, quality improves – GMP is not about quality – it is about defining a process so an auditor can come in with a checklist and see if you are following it. Nothing else.

Andrew' July 18, 2013 at 11:04 am

“Quality” in the professional sense is a very precise meaning and includes trying to obtain same result every time. It’s the Deming notion of quality where the millions of products are as close to the ideally designed product as feasible- there is always variation and it is counterproductive, not to mention cost-prohibitive, to try to eliminate all variation. This is different from the common usage of the word quality which includes all kinds of other things like how good a product is in general.

The dynamic industry and innovation is the part I summarize as calling more Hayekian and a mistake to try to reign in change.

Yes, the Auditor’s role is to check to see that procedures are being followed. The goal of following procedures is process and product consistency.

makomk July 18, 2013 at 4:31 pm

mb, mobile phones are probably not the best example you could have used here. If you take a look at what goes into manufacturing modern mobile phones, the first step is to produce the chips that actually make the phone work. It’s hugely important to carry out every step of that production process in precisely the same way every time, even down to things like the mineral content of the water used in some cases, or the chips just won’t work. The companies that do this employ entire teams to monitor their production processes for consistency, and it costs a truly vast amount of money and time to set up and test new production lines or methods.

What’s more, in order to get mobile phones to their current size and performance, the chip manufacturers have had to figure out ways to shrink down their chips, which involves levels of development, testing and qualification that make the drug industry look positively dynamic and responsive by comparison. This has now happened multiple times.

Lew July 18, 2013 at 6:41 pm

Biggest oxymoron ever:

“Hello. We’re the government. We’re here to help”.

Urso July 18, 2013 at 10:14 am

It’s also not immediately clear to me whether an open vial of urine is all that surprising in a medical lab, or, even if it is, whether the fact that one inspector, at one facility, found an open bottle of urine constitutes some kind of systemic indictment. It’s far too easy to use rhetoric to turn “two 20 cc vials of urine found without lids; small patch of mold found on exterior wall” to “numerous violations were found at the facility – including uncovered urine specimins and mold growth on the walls.”

Andrew' July 18, 2013 at 10:25 am

It is obviously meant for shock value. Tell an average voter about an open bottle of urine versus a nurse behind that little door in the doctor’s bathroom and note the difference in reaction.

Andrew' July 18, 2013 at 10:26 am

In fact, if I were running the quality system and they proposed to get rid of the mold, I’d say “well, you are going to have to re-validate if you make that change.”

Kidding, but a point is in there somewhere ;)

Roy July 18, 2013 at 1:26 pm

healthy urine is about as sterile as any naturally occurring liquid gets.

prior_approval July 18, 2013 at 12:06 pm

There is also a Dilbert series relating to ISO9001, where after being asked about ISO9001 certification, Wally reads off ‘according to our procedures, the price is now doubled.’

It is a funny series of strips.

But metal in a solution intended to feed sick people? That takes GMP to an entirely new level, doesn’t it?

Andrew' July 18, 2013 at 12:10 pm

Quality control is a nice system that is predictably being co-opted by statists. It’s a known issue.

Metal in a solution might be bad, but not having access to the medicine at all might be a tad worse, right? Maybe?

Marie July 18, 2013 at 12:29 pm

Assuming that metal isn’t, say, iron!

Urso July 18, 2013 at 10:09 am

I’m really confused. Your constant schtick is that America should be just like Europe, especially in health care. But here you criticize Tabarrok for suggesting that the US should be more like Europe. Then, halfway through, it’s back to why can’t we be more like Europe?

prior_approval July 18, 2013 at 12:16 pm

‘Your constant schtick is that America should be just like Europe, especially in health care.’

No, my schtick is the U.S. is seemingly unable to actually adopt any of the multiple of less expensive health care models in use throughout the industrial world (not simply Europe), with better results. And apparently, even though Americans tend to believe their system is superior, the actual fact is something completely different (I left out the quote about such basic shortages only occurring in the 3rd world, though that might have been in the metafilter thread from several weeks ago – this is not exactly a timely posting).

‘But here you criticize Tabarrok for suggesting that the US should be more like Europe’

Except Prof. Tabarrok suggests that ‘The article in the Washingtonian covers problems with GMP regulations and the FDA, as I did earlier’ – but in the EU, GMP is standard practice. Along generally strict regulatory control, for that matter. Though the EU does seem to lack any shortage of this particular medical product, and further, has continued to innovate compared to a moribund health care system with the highest costs in the world.

‘Then, halfway through, it’s back to why can’t we be more like Europe?’

Actually, Canada and Europe, and their ability to not have shortages compared to the U.S. But if you actually read the Washingtonian article, don’t miss the role of middlemen in the U.S. system – and the attraction of profiting from shortages. America does it differently – and many Americans seem to think it is a superior system, regardless of actual results.

Andrew' July 18, 2013 at 12:24 pm

They don’t get the same or better outcomes for cheaper methods. They simply don’t do a lot of stuff and the human body is fairly resilient, and for a lot else they don’t record the same statistics.

For example, they don’t do cheaper MRIs with 1/5th the MRI machines, they just do 1/5th the MRIs.

steve July 18, 2013 at 12:55 pm

You are wrong about cheaper prices. If you look at OECD averages, their procedures consistently cost less than ours. For any given country and procedure, the US is usually near the top on utilization, but many other countries lead us in other areas. They rarely come in at 1/5 of what we do. (Back to the old myth that they dont do dialysis on patients over 40 in Europe. And we have to ignore Japan the country which leads the world in MRIs, and they are cheaper.) Most of the time they actually do get similar results. Sometimes better, sometimes worse.

Steve

Andrew' July 18, 2013 at 2:11 pm

A guy walks into a hardware store and asks for a generator. The clerk says “That’ll be $500.” The customer says “hey, that is twice as much as down the street!” The clerk says “so why didn’t you buy it there?” They were out. “Well, when I’m out, mine will be half-price too.”

Andrew' July 18, 2013 at 2:19 pm
Andrew' July 18, 2013 at 2:22 pm

The MRI or CT procedures, for example, aren’t really “cheaper” in the sense that means what people usually mean.

What it is is the government says “we will only give you $X for the procedure” and the market says “well, hell, then we aren’t going to buy any of those machines.”

And the simple denial of medical services doesn’t harm people all that much because most of medicine is quackery. But it’s not anything successful Europe really did by design.

Andrew' July 18, 2013 at 2:55 pm

We are doing the experiment where increased semi-universal “access” increases prices, as predicted.

But I’m seriously curious EXACTLY how you think Europe gets lower prices?

I have a theory. They just do less. They aren’t doing 5 times as many MRIs per machine as we are. They artificially limit demand which is to say they aren’t doing the exactly same things for cheaper. They are manipulating the supply and demand curve and thus are doing something different to get a different price.

What is your theory?

steve July 18, 2013 at 3:04 pm

Andrew’- The entire OECD list, also with CT scanners.

http://www.oecd-ilibrary.org/sites/health_glance-2009-en/04/03/index.html?contentType=%2Fns%2F+Chapter%2C%2Fns%2FStatisticalPublication&itemId=%2Fcontent%2Fserial%2F19991312

Data on actual number of scans, not just machines, and also on costs, which are much lower. (Sorry not for whole OECD, but Commonwealth is pretty reliable on these kinds of numbers.)

http://www.commonwealthfund.org/~/media/Files/Publications/Issue%20Brief/2011/Jul/1532_Squires_US_hlt_sys_comparison_12_nations_intl_brief_v2.pdf

Steve

Andrew' July 18, 2013 at 3:24 pm

Averaging 1/3 the machines and a bit less than half the procedures is not the same as doing the same things cheaper is all I’m saying.

steve July 18, 2013 at 3:36 pm

“Averaging 1/3 the machines and a bit less than half the procedures is not the same as doing the same things cheaper is all I’m saying.” And at half the cost per procedure. (2/3 in Canada). 50% off is a big deal where I come from.

Steve

Marie July 18, 2013 at 12:37 pm

In part that’s due to a differing definition of superior (not between Europeans and Americans, between individuals).

I think a system is superior when I get to make more choices about how to use it. Some think it’s simpler when the choices are made for them so that the system is more simple to navigate.

In the long run we are all dead, but how a patient who personally directs his care gets there (whether his condition kills him or not) is likely to be different from how (and sometimes when) a patients whose path is chosen for him will get there. American complaints about the health care system, like the complaint inherent here, are often about limiting choice, not about eventual outcomes.

wrparks July 18, 2013 at 12:14 pm

How did bad regulation get mixed up with unregulated and free market?

Healthcare and banking have more in common than most think. Both will lead us to the precipice of economic collapse, while being among the most regulated sectors in the economy. Yet people will blame a failure to regulate instead of a failure of the existing regulations. We really are dumb….

JWatts July 18, 2013 at 5:20 pm

I’m relunctant to respond to the Troll, but some people might believe his drama.

And of course, the EU follows GMP. The US follows GMP (good manufacturing practice). Your statement is misleading, and judging by your commenting history, that’s probably intentional.

A good manufacturing practice (GMP) is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

mb July 18, 2013 at 8:20 am

“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all. – See more at: http://marginalrevolution.com/marginalrevolution/2013/07/drug-shortages-are-killing.html?

You see this ALL THE TIME in America. It is a direct result of FDA regulation. Once a process has been validated (a very costly regulatory process) it does not change. I have worked at companies where 50 year old manufacturing techniques were used, does anyone believe these were safer than the techniques available now? Nobody is that stupid, but any new process would need to be validated, so the same old techniques are used. Never mind improvements in cost and other aspects that could be had if new techniques were adopted. The FDA is terrible organization and its rules kill.

Andrew' July 18, 2013 at 8:28 am

I concur that manufacturing cargo cult traditions are difficult to change, but at least they have a strong internalized interest in improving them.

Rahul July 18, 2013 at 8:33 am

FAA is similar. A lot of flying technology remains ancient because re-certification costs tons of money.

Onerous validation also proves to be a huge barrier to entry by new firms. Competition in aviation components is low.

Ergo costs are ridiculously high: I read somewhere that replacing just a single pilots’s seat on a Boeing wide-body costs in the range of $50,000.

mb July 18, 2013 at 8:53 am

I do not know about the FAA, but with the FDA everything in the manufacturing is specified (equipment used to ingredients) if anything is changed, the process has to re-validated (unless an equivalent item is substituted – then a less costly study is required to show equivalence). In this case, an active ingredient change is being proposed – this is essentially a new drug, meaning an NDA, clinical trials, validation – you start over. No company is going to do that, the risk of FDA rejection of the new drug is too high (if the new drug can’t be proven statistically better, the FDA rejects – which is whole other problem – incremental improvements (i.e. most improvements) are never made).

TallDave July 18, 2013 at 11:34 am

Back in the 1990s, the joke was if aspirin was invented today it would never be approved by the FDA — for one thing, no one knew how it worked.

mb July 18, 2013 at 9:55 am

another way to look at is this, imagine if an Airline had to validate all the routes it flies (equipment used load bags, fuel the plane, etc.), not just the plane. If you used a different plane, you need to submit a NPA (new plane application), clinical trials, and re-validate. New airlines would have to prove they offer better product before entering the market (costs are not considered). And on and on, it is absurd the “market” the FDA has created. Then people blame the “market”. People (liberals in this case) really need to start thinking.

CBBB July 18, 2013 at 8:37 am

But it’s not as if European countries tend to have no or few pharmaceutical regulations. The correct place to look is probably the buying out of politicans by unlimited campaign contributions from incumbent pharmaceutical producers

mb July 18, 2013 at 9:03 am

The FDA regulations have a cost, those costs are high (the highest). Let’s look at any other manufacturing segment, are American manufacturers at a disadvantage due to lower regulatory costs in China, India, etc. Are french manufacturers at a disadvantage due to french labor laws? I have already witnessed pharma manufacturing off shored for a drug that was never going to be sold in America (it was targeted at developing countries, there is a better more costly drug for the first world). If it was going to be manufactured in America it would have to comply with FDA regulations and there would be no way people in developing could then afford it. Regulations cost money, while I agree pharma companies are protecting themselves, I would also bet there is a SUBSTANTIAL amount of lobbying by the FDA on this issue as well – they would cease to exist.

Andrew' July 18, 2013 at 9:28 am

This is probably not about bought politicians as much as it is about misconceptions of voters and inefficiencies of democracy. It is barely any skin off the FDA’s nose if people die from their sins of omission unless we make a big enough stink over it while we don’t get paid to do so, and even then it is touch-and-go.

mulp July 18, 2013 at 3:11 pm

Ok, let’s outsource the FDA the EU regulators.

Ooops, the EU regulators are soooo horrible in stopping great innovative products from the US being sold in the EU on the claims the product safety has not been demonstrated…

And how can any economist support importing drug made in the heavily price control EU which prevents all innovation in drug production – clearly the price control and government central planning means their drugs are decades behind the US high profit incentive drug industry.

Richard Besserer July 18, 2013 at 8:53 am

I have a question. How is phosphorus organic? It’s not even a carbon-based compound, much less grown in cowpies.

Must go to my local Best Buy and inquire about organically grown laptops.

Jeff R. July 18, 2013 at 3:22 pm

Even without the chemistry-class-definition pedantry, I too am curious about exactly what distinguishes an organic phosphorous solution from a non-organic one.

Marie July 18, 2013 at 4:42 pm

Wouldn’t it be the solution part?

ivvenalis July 19, 2013 at 8:19 am

Organic doesn’t really mean carbon-based, it means it’s “biological”. Back in ye olden tymes, chemists believed that there was a metaphysical difference between certain compounds found in living beings (“organic”) and regular old non-living (inorganic) material such that organic and inorganic compounds couldn’t be synthesized from each other. Mostly it just turned out that what are still referred to as “organic” chemicals were generally complicated.

Andrew' July 18, 2013 at 9:03 am

Hey Alex, we need a new Tabarrok curve!

Andrew' July 18, 2013 at 9:05 am

“The root causes of drug shortages . . . lie largely outside of FDA’s purview,” she wrote. “During 2011 nearly 70 percent of all drug shortages were related to manufacturing production problems, including quality-related issues and delays.

Will high level government officials EVER stop blataintly lying to our face?

CBBB July 18, 2013 at 11:51 am

But then why does the article praise Europe? Surely the regulation is just as stringent in Europe. Of course the FDA has costs and perhaps it could be better organized but it’s not clear this is the sole reason behind shortages. Or perhaps the FDA is simply yet another US institution that has fallen under the corruption of big-money politics and is run for the benefit of incumbent suppliers

Andrew' July 18, 2013 at 12:12 pm

I suspect the regulation is different in Europe. I think Europe is nuts and would almost never praise them. Maybe in this case they are just lucky.

Andrew' July 18, 2013 at 12:17 pm

I’ve related this before, but I did some looking around for some REALLY trans-fat free coffee creamer. When researching the one I found I came across an FDA warning letter warning the company off making statements on their website about the health benefits of REALLY trans-fat free.

So, we have a government that allows 0.5 g of trans fat per serving to be advertised as Zero trans fat, but disallows a company from advertising REALLY trans fat free as a healthy alternative.

I’ve seen Europe do this kind of stuff even more often, but maybe by pure dumb luck they aren’t as dumb as we are in the generic drug and simple vitamins example Alex’s post refers to.

Andrew' July 18, 2013 at 12:17 pm

I’ve related this before, but I did some looking around for some REALLY trans-fat free coffee creamer. When researching the one I found I came across an FDA warning letter warning the company off making statements on their website about the health benefits of REALLY trans-fat free.

So, we have a government that allows 0.5 g of trans fat per serving (which is a shit ton if you drink as much coffee as I do) to be advertised as Zero trans fat, but disallows a company from advertising REALLY trans fat free as a healthy alternative.

I’ve seen Europe do this kind of stuff even more often, but maybe by pure dumb luck they aren’t as dumb as we are in the generic drug and simple vitamins example Alex’s post refers to.

Marie July 18, 2013 at 12:43 pm

My favorite is the Panera commercials and the Safeway generic health foods and others that advertise chickens as being raised antibiotic free. All chickens are raised antibiotic free. That’s *cows* you read that article about that one time in the dentist’s office. Chickens you want the free range for the nutrition and fewer beaks cut off.

Bought beef from a rancher once who would have the butcher come out to his ranch to slaughter the cattle for less stress and cleaner process, out in the field instead of a slaughterhouse following a feed lot (lots of wallowing in dung in those places so it’s harder to keep out the E. Coli). But he couldn’t put “natural” on his beef. The Walmart guys who wash their beef in ammonia, though, they’re good to go.

Michael July 19, 2013 at 2:41 pm

It is a fallacy to say that “the EU is high regulation and the US is low”, it is very situation dependent. On the aggregate this might be true, but it varies quite dramatically if you compare the two sector to sector.

Capitalism and Sweden I think is the classic example of this.

TallDave July 18, 2013 at 9:05 am

These systems are just too complex to manage centrally.

Andrew' July 18, 2013 at 9:08 am

I can accept wishful thinking from progressive utopians. I won’t accept “the shortage has nothing to do with us…except for the fucking warning letter that shut down the sole supplier.”

prior_approval July 18, 2013 at 2:40 pm

‘the shortage has nothing to do with us…except for the fucking warning letter that shut down the sole supplier.”’

Except that is in no way true – the world is full of suppliers of such medical necessities. A world where those necessities are bought and sold without problem.

It is only the U.S. which does not participate, preferring its own methods. Outdated ones, which do not meet the standards necessary to even export to other markets, it must be noted.

There is no way that the EU would accept IV solutions with metal in them – neither by manufacture nor by use (one did notice how in the U.S., according to the article, methods are being used which are essentially lunacy to stretch supplies, right? – American exceptionalism in practice.) But then, the EU is in the thrall of essentially universal health care systems which at their worst, cost a third less per capita than the American version which leaves tens of millions without any access to health care apart from emergency rooms – which do advertise their waiting times on the highway, at least in VA, on 95.

steve July 18, 2013 at 3:22 pm

This problem has existed for many years. It it mostly injectable drugs. Nearly all of them off patent injectable drugs, which should be a major clue. If this is all due to govt policy, then why isn’t it affecting drugs still on patent, ie the expensive ones? Most of this really is due to to manufacturing issues. They found ground glass in one of the drugs we were regularly using, so they shut them down. Other times, since there is often only one or two firms making these low margin generics, there have ben problems on a production line or issues with supplies. Other firms are unable to gear up quickly to make up the difference. Having talked with some of the committee members of my society who have investigated this, we havent found that this is some big govt snafu.

That said, Alex is right that we should be letting in more European drugs. Heaven knows i have used a lot of German drugs over the last few years when we got exemptions when things were tight. No one died. Whatever is different about the European system, they dont seem to have the drug shortages that we do.

Steve

mulp July 18, 2013 at 6:40 pm

We are importing lots of drugs. And most (~80%) drug ingredients.

But what you are calling for is the unregulated import so counterfeits can be easily imported from Asia in the exceptionally good counterfeit packages with counterfeit holograms. Right? Everything on the Internet will work if you believe it will by the placebo effect!

Andrew' July 19, 2013 at 6:35 am

Patents are a government program.

PA, yes it is true. The FDA sent a warning letter and the manufacturer had a couple options and chose to shut down.

Now the FDA has “helped” by allowing them to filter the metal out of the drug.

So, they are still allowing, after a certain amount of morbidity and mortality, to allow the drug with the metal.

Be careful, I have a new policy.

Andrew' July 19, 2013 at 6:37 am

And drug reimbursements are >50% a government program with all the liberals screaming for the government to exert their purchasing power to strong-arm drug manufacturers.

So, don’t bring the “cheap drug-maker greed” up in here. Mind the new policy!

mulp July 18, 2013 at 6:34 pm

“Many of these products, especially the simpler ones, are available in Europe but it is illegal to import them to the United States.”

That is a false statement. For example, from a Teva SEC filing:

“Teva USA derives a majority of its sales from products manufactured outside of the United States mainly by other Teva subsidiaries.”

What you mean is that it is illegal to import controlled substances – primarily drugs – without the approval of the FDA, which means you can’t legally import laetrile, cocaine, heroin, IV drugs without getting a license from the FDA to do so. The FDA then verifies the drug is approved for the US market and that the manufacturing meets standards, and a chain of custody limits the risk of counterfeits entering the US drug supply chain.

With many drugs being counterfeited to save a penny in material cost for the active ingredient with lots of money spent replicating packaging including holograms, such concerns seem reasonable. And doctors, clinics, and hospitals sourcing drugs in the US has not been without problems – the doctors involved failed to see the problems the drugs they were buying from the pharmacy they chose were causing in hundreds of cases.

Further, it is generally accepted that about 80% of drug raw ingredients used in the US are imported and I’m guessing that is the pharmacy grade calcium, et al, that are key ingredients in your list of IV solutions. That is due to globalization. The FDA has approved the manufacturing plants and processes of overseas suppliers of these ingredients, but the mergers of drug corporations leads to global corporation closing a factory that makes the majority of supply for one of these ingredients – that one ingredient is not a big money maker so closing the factory and upping production elsewhere for the duplicates and assuming the market will replace the supplier as the invisible hand is supposed to. Only US manufacturers need to notify the FDA a year before shutdown of production of any drug or drug ingredient.

If imports were in fact illegal, then the FDA would be able to address shortages by being notified well in advance of changes that will lead to shortages. The US with only 5% of the global population can’t be using more than 25% of the global production of drugs, so locating manufacturing globally when demand is global and supplying the US with imports is the logical result of globalization.

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Norm Howe August 14, 2013 at 11:49 am

The GMP violations that FDA found in many of the vaccine plants were unconscionable. Just one example: an umbrella turned upside down in a clean room that was being used to catch water leaking through the ceiling. Did anyone get sick because of this? Well, there was nothing reported. But, this is like landing safely with a parachute and then finding that the reserve chute was all moth eaten.

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