One of the early on-line responses was "maybe we can figure out how to 3D print these cases". It turns out that an Epi-pen is just a plastic safety housing around a normal syringe.
That second discussion got heated quite fast. I agree with the downvoters though. 3D printing a medical device is not something to take lightly.
Edit:
Here's why I agree.
You download this design from the internet, and 3D print the parts. You then assemble it. Awesome!
Some time later, you get an allergic reaction. You use the pen, but it fails to work correctly. Who's responsible? The designer? You (if you're alive)? The printer manufacturer? Your friend who emailed you the design? etc.
There's a reason why even getting such a simple design considered for FDA approval and certified for use on live humans is such a long and complex process. It's easy to make something that works some of the time, but it's extremely hard to make it work essentially every time, especially in life-or-death scenarios.
Of course, the price hike is terrible and the company behind it deserves punishment, but that doesn't make it OK to endanger the lives of people.
Scarcity demands innovation. I don't think its being taken lightly; more like, "a private company is gouging medical users and the government won't step in". Not left with many options when your life depends on it.
EDIT: Alternatively, a "better" temporary solution would be to arrange for the import of these from Canada, where the price is fixed by the government.
It's not merely size. It's size-relative-to-market.
Canada negotiates with drugs suppliers. Supplier says "take a hike". Canada says, "OK, you're out of the market", turns to next drug supplier.
Canada here has right-of-refusal, and can negotiate, as a single block entity, with ability to restrict market, to each. The drugs company which finds those terms acceptable has a market.
A bloc of 42 million in the US is only about 12% of the total market. The discussion there still leaves another 290M possible customers for a drugs vendor. Hence the strength is with the vendors.
If US Medicare had rights to exclusively negotiate drugs deals (it doesn't), this would change tremendously. Similarly for single payor.
Which is precisely why the entire medical services industry is so mortally opposed to it. They'd lose absolutely all market leverage. They know this.
The autoinjector provides value for people that don't do IM administration every day. It's rugged, sterile, can be used right through clothing if necessary, and provides the right amount of force to go through to the muscle. The kit might also include a practice injector for training the user.
Oh and it's probably a little hard to handle a bottle and syringe on yourself while you're suffocating.
That's an alternative, but is more complicated and the vials of epinephrine only have a shelf life of three months vice twelve to eighteen for the EpiPens.
That makes too much sence for the FDA, AMA lobby, big pharma, and very entity/persons that makes a killing off health care.
As to the simplicity the EpiPen, I once used it, and under stress didn't do it right.
When I was younger I was very interested in medicine. In college finished all pre-med courses. Interned at a Coroner's office, etc. Even spent some time in med school. Very familiar with giving a subdermal injection.
Now my father had a bad asthma attack years ago. I knew he was in poor health, so my stress level was high. He blurted out where the EpiPen was kept. I got the device, didn't have time to read the instructions, and just stuck it in his thigh. I apparently pulled it out too quick--just wasn't thinking, and nervous. I pulled it out so quick, because I was scared, felt the device was foolproof, and felt weird hurting my father. We luckey had enother one around, and injected him longer this time. If I was forced to use a syringe, their would be no assuming. "I need to get the drug into the syring. I then need to empty the syring into his thigh. Done?"
Well it didn't work, and he ended up in the emergency room. He survived.
I drove home feeling guilty, and still do today.
I always felt a kit with a single dosed bottles of epinephrine, and a syringe would make intuitive sence to a lot of people? I know I would have felt more comfortable that night.
I honestly think the powers at be underestimate the abilities of the average person, especially a person who's had an previous asthma attack. If a doctor/nurse spent a minute showing a patient how to injection themselfs with epinephrine; I don't think most would ever forget. Plus--we have all watched injections given on the boob tube? "But the average person would probally jab the syringe in the Carotid artery, or pull a Pulp fiction." They could jam it into a carotid, even with a EpiPen--with enough effort/stupidity?
I hope in the future we have over the counter life saving medications over the counter, including naloxone.
Demand passing a basic test if worried about consumers hurting themselfs? Something like a CPR certification? If the patient can pass, they can buy cheap medications over the counter? They don't need fancy propriatiatry drug delivery gadgets in so many cases.
I really think the only way to bring down medicine costs will be to make many drugs OTC, and demand basic competency exams if worried about ineptitude? There will always be people out there that will find a way to abuse/overdose/screw up dosesages on medication. Let's just try it for a year? Especially with certain life saving drugs. How many diabetics die each year because they don't have a prescription for insulin, and couldn't get to a hospital?
I used to have so much respect for any sector of the health care; now I look at most of them with utter discontent.
Sure... but then there is the problem of the end user.
Is there 3D printer correctly calibrated? will miscalibration effect its end use? how can you test to make sure the printed design is working as intended?
Can the printed plastic withstand direct sunlight for days on end? Some printed plastics become brittle over time in sunlight (PLA for instance).
When the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose.
Most people I know couldn't handle a sudden $600 expense
like a car repair without help from someone like their parents (I'm mid-20s living in JP).
> When the difference is $1 vs $600, I think a lot of people would be willing to take that risk, especially for something that is basically an unexpected expense; I doubt any allergic people are getting stung by bees on purpose.
What probabilities are you assigning to needing the printed epipen to survive, and to it functioning correctly, such that it's worth that risk?
I get where you're coming from. I guess my point was that to most people $600 might as well be $6,000 or $6,000,000, since that's not something they can afford on their own. At that point, the dollar version is (hopefully) better than nothing.
Dying because you can't afford a device you need is also not something to take lightly. It may not be a good idea, but blame should lie with the manufacturer for raising the price to such ridiculous levels.
Yes; this is why using the free market to set prices in health care is always such a troubling thing. People don't like the idea of putting a price on their health.
Please don't blame the free market for these high prices. This is a highly regulated medical device market with patent protections and insurance market complications.
The price hikes would immediately attract lower-cost competitors if this were truly a free market.
> The price hikes would immediately attract lower-cost competitors if this were truly a free market.
Any participants in a free market for a product with inelastic demand (e.g. something you need to stay alive) and non-trivial entry costs immediately implements price fixing in the absence of regulation.
When life-saving devices that require a significant supply chain to manufacture capture the bulk of consumer surplus from the majority of potential customers (and the poorest are left to die), the free market is working as intended, efficiently allocating resources to maximize profits.
The non-trivial entry costs are there because of regulations and the legal environment regarding liability.
You can view the high price as the free-market finding the intersection of supply and demand given the regulatory and legal constraints but that seems like a less than useful way of understanding 'free-market'.
> You can view the high price as the free-market finding the intersection of supply and demand given the regulatory and legal constraints but that seems like a less than useful way of understanding 'free-market'.
Stop using regulation as a stalking horse for your argument. Everything you need to know about the price of epi pens you can derive from inelastic demand (people don't want to die), and barriers to entry (copyrighted brand, network of doctors writing prescriptions, and yes, FDA approval so these things don't kill people).
The price is high because people will pay almost anything to not die. This drives the price point up to capture consumer surplus. It's easy to understand.
The Free Market isn't a magic bullet that will drive down these prices. For one simple reason. Rational actors don't compete on price. I'm going to repeat this, because so many people don't get it.
Rational actors don't compete on price. Rational actors will spend up to their expected monopoly profits to create a Nash Equilibrium where new entrants into a market will be unprofitable. The simplest way to do this is through dumping. (see "competition" in the generic drug market for example) Why doesn't this happen in every market? Regulation.
Maybe you don't like that in unregulated markets, people starve, are poisoned, are denied treatment, and worked like slaves. Because that's how you maximize profit, by minimizing your own costs by maximizing externalized costs. So you'll think anything to avoid that realization. Like blame 'regulation' for what's obviously rationally maximizing profits.
And if you want to know how exactly the 'free-market' for medical supplies would work without regulation, just look at the 1800s. Demand was still inelastic, so prices were high, quality was low (for obvious reasons), and competition was still stupid, because price fixing and dumping were still more profitable than competing on price.
Let me see if I can be a bit clearer. A market with high barriers to entry that are defined by regulations and legislative constraints is not a free market. It is a market, just not a free market.
Blaming high prices in this situation on a failure of the market mechanism is simply inaccurate. The high prices are a result of the constraints that prevent competition and the emergence of a free market.
I'm not sure what to say about your assertion that price isn't a component of a competitive market. Certainly competitors try to compete on 'value' of which price is a component among many others (ease of use, features, reputation, availability, etc.).
I don't know what you are defining as 'unregulated markets', but I'm not advocating for the removal of legal frameworks that prevent fraud, negligence, collusion, and so on.
I have a PhD in economics, and your claims about monopolies and competition aren't accurate.
Economic theory doesn't state that monopolies always arise, at least not under the circumstances you are describing. If you can buy your competitors, or make a legally binding contract to compete, the yes, monopolies are inevitable. And as you say, inelastic demand does make monopolies more likely, though your intuition that medical goods have inelastic demand may be wrong, e.g. see the RAND health care study where they randomly assign people insurance types, and find the high deductible group consume less healthcare even in emergency situations.
In the general situation, no theory guarantees that monopolies arise in the absence of regulation (apart from the above to cases which aren't the regulation you're discussing).
>Rational actors will spend up to their expected monopoly profits to create a Nash Equilibrium where new entrants into a market will be unprofitable.
In economics, anything that relies solely on Nash Equilibrium is doubtful. In most situations, Nash Equilbria are not unique, and therefore it's hard to say what will actually happen. If the Nash Equilibrium is unique, usually some stronger equilibrium concept applies like dominant strategy equilibrium.
In your case it would be more accurate to say that committing to drive out potential competitors can be a Nash Equilibrium for some parameters.
> Medical costs started angling up steeply in the 1960s with the advent of heavy regulation
Broadly, to a first approximation: Medical costs, real-estate, and education have increased in price to capture the consumer surplus created by the decline in food. clothing, and fuel costs.
> Isn't dumping competing on price?
Nope, dumping is used to drive new entrants out of a market. It also acts as a signal to prevent new market entrants.
If I sell 2 million widgets per year at a price of $10 over a cost of $1, after $4 million in capital costs, I can maintain a monopoly if I'm willing to drop my sale price to 50 cents every time someone enters my market, and I raise the price when they exit it.
This creates a Nash Equilibrium were no rational actor will spend $4 million to build a factory to compete with me.
> have increased in price to capture the consumer surplus
It is quite a remarkable coincidence that medical costs angled steeply upward immediately after heavy regulation and government involvement in it began.
> I can maintain a monopoly
It'll be pretty hard to swallow $1 million/year in losses to do so. You'd have to maintain those losses to beat back even a small competitor, who would have proportionally smaller losses. A small competitor would have the capability to ruin your business with a small investment on their part. I bet they could finance it by shorting your stock.
The US government has been heavily involved in regulating medicine since 1906. The only reason why "medical costs angled steeply upward immediately after heavy regulation and government involvement in it began" is because "heavy regulation" is a weasel-word; you could pick almost any point after 1900 or so and claim that's when it started in order to justify that argument. Take a look at the list of milestones here for example: http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/ucm1...
The two seminal events in the 1960s are the FDA 1962 "effective" mandate, with subsequent sustained price spikes is well documented in Peltzman's "Regulation of Pharmaceutical Information".
The other one is the enactment of Medicare/Medicaid in 1966/1965. From the graphs I've seen, that corresponded with the knee in the curve.
> It is quite a remarkable coincidence that medical costs angled steeply upward immediately after heavy regulation and government involvement in it began.
Regulation didn't give people more money to spend on medicine. Offshoring jobs to China drive down prices of consumer goods to make more money available as a consumer surplus that could be captured by healthcare.
If the price of food increased, the price of housing, education, and medical care would decrease. Because the demand curve would change.
> A small competitor would have the capability to ruin your business with a small investment on their part. I bet they could finance it by shorting your stock.
That's a nice hypothetical that completely ignores all of financial theory AND history. If you ever start a company, let me know so I can short YOUR stock.
Why wouldn't it be captured by farmers? or carmakers?
> all of financial theory AND history
Can you give case history of a company that maintained a monopoly via periodic dumping to bankrupt any competitors? I'm not aware of one, and no, Standard Oil is not one (see the book "Titan" about it). I've read many econ/history books, and none them put forward your dumping theory. Do you have a book reading list?
> The non-trivial entry costs are there because of regulations and the legal environment regarding liability
I think that misplaces the cause. The requirement for safety and the high cost of failure is what creates those regulations and liabilities.
Theoretically, we could eliminate the regulations and liabilities and just let people die, but 1) that's a really bad idea, and 2) it would be excluding from the market mechanism (i.e., externalizing) the most important aspect of the product, its safety.
Suppose there were no regulations and no liability for manufacturers. Would you really trust your life or your kid's life to some unregulated clone of the EpiPen that may or may not actually work properly when needed, knowing that if it went wrong the manufacturer wouldn't even have to pay one cent of your medical bills and didn't have to worry about liability for screwing up? I suspect not.
You would if you literally didn't have $600 for the brand name version.
Maybe $600 is an amount that everyone can get with some sacrifice but there are other drugs/devices/procedures that cost $10,000s or more where people just have to go without because they're not allowed to take a chance on an unregulated alternative.
I can think of many products which are life-saving which are readily available from countless producers for relatively cheap. The difference here is just as gwright has pointed out and you have a corpus of regulation which makes this particular product more expensive and/or chokes out competition.
The only sectors of the economy where significant, lasting shortages occur are the ones most heavily regulated.
> The only sectors of the economy where significant, lasting shortages occur are the ones most heavily regulated.
So you're saying that Petroleum Exporting Countries would never say... create an Organization intended to increase the price of oil?
Or the DeBeers wouldn't collude with diamond producers to limit the availability of diamonds to increase the price?
Or that manufacturers and distributors of light bulbs, lysine, copper, cleaning powder, vitamins, glass, milk and machinery would never, ever engage in price fixing?
I want to live on your planet, where capitalism is so nice and perfect that companies rush to give away all their profit by competing the marginal cost down to zero without any of those pesky regulations.
> In the software business, with pretty much zero regulations, competition has run the price literally to $0 for broad swaths of products.
That's like saying that price competition is alive and well because banks will give you a free toaster when they charge fees to loan your money back to you.
But to address the specifics of the software industry, software is a complementary good.
I know many software companies with essentially a single product, which they give away. They make money selling service contracts, which enough customers buy to make it worthwhile.
The price is still $0 and there are still no regulations on it.
Most (all?) commercial products have complementary products. This is hardly unique to software. I seriously doubt the theory that medical products have no complementary sales.
> The only sectors of the economy where significant, lasting shortages occur are the ones most heavily regulated
That's not what economic theory (and practice) say, I'm pretty sure. For example, unregulated electrical, communication (including Internet service) and transportation markets have resulted in shortages in rural areas. Unregulated food and housing markets (and many other markets, including Internet service) result in shortages for poor people. Unregulated fishing creates shortages of fish - a 'tragedy of the commons'. Monopolies and oligopolies eliminate whole categories of products.
The free market is very good for some purposes, but it's not a benevolent God that finds solutions to all our problems. It's just a very useful tool in the toolkit.
I would first like to point out that in the context of this conversation the definition for shortage I am using is that there is a shortage of a good or service where it once was readily available. Sure I could, say, take a rocket ship, to mars and denounce the absence of internet connectivity, but that's not what I'm referring to here.
>unregulated electrical, communication (including Internet service) and transportation markets have resulted in shortages in rural areas
Again, according to my above definition this is a slightly different topic, but it seems highly dubious that a lack of regulation is what has resulted in shortages of internet service is some podunk town.
>Unregulated food and housing markets (and many other markets, including Internet service) result in shortages for poor people
The most significant factor limiting the availability of low cost housing is municipal regulation, not the absence of it. I'm not aware of any place in a developed nation which has a shortage of food. It seems what you are getting at is the options may not be affordable for some, but that is a different concept from a shortage. Furthermore, it is a bit of a stretch to refer to the food and housing markets as "unregulated". If there are any shortages in these markets it's certainly not due to a lack of regulation.
>Unregulated fishing creates shortages of fish - a 'tragedy of the commons'
I have commented on the idea of "tragedy of the commons" many times. It generally leads to quite a tangent in the conversation, but if you're truly interested I'd be happy to discuss why the problem does not lie with a lack of regulation.
>Monopolies and oligopolies eliminate whole categories of products.
A true, lasting monopoly is only possible through market regulation which strangles out competition. All the textbook examples of "monopolies" (Standard Oil) were not monopolies at all. In fact in the early days of electricity there was so much competition in the big cities that the big guys lobbied hard to get their monopoly privilege.
You make many claims in strong langauge, but that's not itself meaningful. They are at odds with what I learned from economists, and from what I believe is the very widely accepted consensus in the field (though I might have a few details wrong). Regulation is a normal, effective response to market failures, which sometimes result in shortages.
Of course, I'm not providing any citations myself!
Yes, but in other countries everyone gets the same access to health care and people don't die on the street because they can't afford a commodity like an epipen! Though you might die in a hospital bed because the government wont spend a million euros a week on medication that may or may not give you a year more to live.
Of course. This case is particularly interesting because the device/drug combo is so commonly needed. But you'll find many other stories of manufacturers hiking the price of drugs people need to live, and the resulting backlash. Look up Martin Shkreli for a couple of recent examples that got attention.
We also see drug shortages because the lone manufacturer temporarily or permanently stops manufacturing. For example, there's an ongoing injectable estrogen shortage because the manufacturer has an issue sourcing a key ingredient [0] [1]. (Thankfully, other forms and dosages are not impacted.)
Then why are they making hundreds of thousands of epipens? Sounds like they should make like 100 a year and auction those suckers off. Less material and capital to manufacture, same profits.
doubtful that an auction that would demand those profits would be 1) easy to facilitate 2) stable and predictable.
Also, the individual price per unit would rise to the point that there would be another competitor to the market.
My point is that you can't cry about government controlled health care, and high prices of "free-market" items at the same time.
So either we have a gene pool cleansing and accept that people die, or a controlling entity uses force to coerce the manufacturers to adopt practices that will make it available at "reasonable" prices to the populous.
The manufacturer is obligated to (1) obey the law, and (2) maximize profits for shareholders. If you have a problem with the current situation, blame the government/laws[1], not the company.
[1] Blame is justifiably attributed to the government whether you believe the fix is a freer market (to reduce the costs associated with bringing suitable competitors to market) or you believe regulation should prevent this from happening. Apart from the requirements codified into law, we should have no expectation of altruism by companies, especially when their existence is intrinsically related to profit-seeking motives.
(1) seems like a total cop-out to me. By that logic, you can blame everything on the government. Some guy murders his family in a fit of rage? Government should have done a better job preventing it.
Also, part of the point of this kind of outrage is to punish these companies for their behavior so that the evil choice is not the most profitable one.
If corporations don't have an obligation to maximize profits for shareholders, then you'd better try and take that argument to shareholders rather than believe someone's opinion piece on the matter.
I didn't say corporations are legally required to seek profits, but they do have profit-seeking obligations in most cases. Without investors' expectations of future profits, those companies wouldn't exist in the first place.
And last I checked, murder is illegal, so no, I can't expect the government to do anything beyond that (as long as that law is enforced).
There is no inherent obligation to maximize profits. Most companies have that as their goal because that's what their shareholders want. But then saying that the manufacturer is obligated to maximize profits is a really bizarre and rather disingenuous way of saying that the people who actually own the manufacturer prioritize profits over lives. They don't have to do that, they just do. There's no "obligation" anywhere in there, just people's preferences. Saying that companies are obligated to maximize profits is just a way of saying that it's OK for people to value money above all else, even the well-being of their fellow humans, as long as there's enough indirection in the process.
If not for laws and government-mandated standards, how would you go about making sure companies put the "correct" value on lives vs profits?
I can hope my neighbor is a decent human being and that he'll be a good neighbor when people around him are in need, but I personally won't blame him if he doesn't. Similarly, if he's being a nuisance - without breaking any laws - I still can't really expect him to stop (just because I value my peace more than he does) unless I do something to change the law. I can whine about it all day long and tell him it's "not OK", but if I don't do something to change the law (or move), then the only person I can really blame is myself. Blame is only useful so far as it actually has any "teeth" to improve the situation.
It comes down to this: we all want the world to be a better place. We can hope and expect everyone else to live up to our ideals (and complain when they don't), or just do our best to live that ideal ourselves. Anything serious enough to warrant restrictions or mandates on the behavior of others is probably within the realm of legislation.
Making a company's customers upset tends to have teeth. There's a reason companies spend money on PR instead of just keeping that money as additional profit, after all.
If your neighbor is being a nuisance, it may be more effective to gather up some of the other neighbors and all go over to the fellow and tell him to knock it off.
I don't have any actual solutions to propose here. Maybe it merits legislation, maybe it merits consumer action, maybe it's just an opportunity for some other business to create a competing product. I just don't like criticism of people trying to work around a life threatening problem without also acknowledging the source of the problem, and I especially don't like justifying bad corporate behavior on the mistaken principle that corporations must prioritize profits above all else.
Gathering a group of neighbors and telling him to knock it off doesn't have any teeth either, I'm afraid. He can still say "screw you, I'm not breaking any laws, so you can't do anything to stop me."
I do agree about upset customers having teeth. That's exactly how a free market operates. If they're upset enough, they'll stop buying the product and look for alternatives. Except there aren't any suitable alternatives to EpiPen on the market, and it's a potentially life-saving product, so those teeth don't have anything to bite in this case. I'm sure many, many other companies would love to seize that opportunity. So what's stopping them from competing? Answer: unnecessarily complex government regulation.
Or, if that approach doesn't resonate with your worldview, then go out and put pressure on the government to regulate the prices of things like EpiPen.
Either way, the answer lies in the government, not the corporation. The company hasn't broken any laws. We can wish they'd lower prices, but we might as well wish for pink unicorns. The answer for your neighbor is the same - you can't expect him to be reasonable just because you gave him a stern word.
Yes, your neighbor can just ignore you, but he usually won't. Social pressure tends to work. That's just as true of companies as it is for bad neighbors. If your argument is merely that it might not work, then we're completely in agreement.
You can try the social pressure route every time this happens (and if you haven't noticed, this seems to be a recurring issue in health care), but unfortunately that's going to take more effort in the long run with fewer results. Many companies - whether morally justified or not - just won't respond to social pressure.
Or, redirect those efforts into fixing the issue through legislation (either to open up the market to more competition, or to restrict price gouging). That's a battle you only have to win once, so in my opinion, it's a far more effective use of one's time.
But if you prefer to cry out that life isn't fair every time people do things that aren't illegal, that's entirely acceptable. I'm glad to see we still have the liberty to speak our minds, regardless of ideology.
How am I, an average citizen, supposed to fix this issue through legislation? Write to my representative? He'll just throw my letter on the pile, and our useless legislators will continue being useless.
The only way to get any legislative action on this is to get the electorate to care about it so that legislators get convinced that they need to act on this in order to keep their constituency returning to the polls and checking off their name.
And in order to do that, you need to talk about how problematic and reprehensible these moves are, so people actually care about it.
So really, both the social shaming and legislative approaches start out the same way. Unless you think you're talking to a dictator, your "stop whining and pass some laws" approach is nonsensical.
> The only way to get any legislative action on this is to get the electorate to care about it so that legislators get convinced that they need to act on this in order to keep their constituency returning to the polls and checking off their name.
> And in order to do that, you need to talk about how problematic and reprehensible these moves are, so people actually care about it.
It sounds like we're in agreement there. The only difference is, you've expressed an unrealistic expectation with regard to the effectiveness of social pressure directly aimed at the company involved. If history is any guide, we can only expect systemic improvement in this scenario through legislation and/or deregulation. Otherwise, you're merely treating symptoms of the problem, not the cause (and no, the cause isn't capitalism or profit-seeking companies as many may have you believe).
Now, if trying to fix problems in our country through the use of a system of rules and regulations (aka, laws) that has been established for that very purpose is nonsensical, then so be it. I suppose that view is indeed nonsensical in the context of today's prevailing social attitudes.
Fiduciary obligation is complicated and jacking up prices in the short term result in lower profit than keeping prices lower -- if this company wanted to keep the price of the product low, they could easily justify it by arguing that indiscriminately raising the price would invite government regulation and price control (or invite more competition), which would reduce profits in the long run.
Shareholders already know that companies don't have an obligation to maximize profits. Tim Cook among others has made this point forcefully fairly recently.
Shareholders make investment decisions based on their own opinions of which companies are most likely to generate the highest return over their preferred time span. That is not the same thing as believing in an obligation.
Company misbehaves, government nationalizes them. It's a perfectly valid approach often used in the US, which places the blame on the company not the government as it should be.
Sure, we mostly stopped doing this for various stupid reasons, but legally it's sill an option.
It's surprisingly frequent, though generally short lived.
Legal and profitable mob run businesses are taken over vs shut down then resold once the books are clean. During World War II, Washington seized dozens of companies including railroads, coal mines and, briefly, the Montgomery Ward department store chain.http://www.nytimes.com/2008/10/13/business/worldbusiness/13i... Banks are probably the most common but it can also happen in bankruptcy.
You misread the WWII example which was considered completely ok. In different war: "In 1952, President Harry Truman seized 88 steel mills across the country, asserting that unyielding owners were determined to provoke an industry-wide strike that would cripple the Korean War effort. That forced nationalization did not last long, since the Supreme Court ruled 6-2 the action an unconstitutional abuse of presidential power." (You might want to read it vs skim.)
Also of note, their are thousands of examples in history, this is just referencing a few hundred to make a point.
PS: It's also worth noting that the mob example was taking control not just ownership. These companies where money laundering for example so they needed to remove people from the payroll who did not work there.
Consider myself properly chided. Still, I don't think the case was "considered completely ok". From what I can tell from newspapers of the time, the case was dismissed when the governmental occupation ended.
Companies have those obligations, and others too. We all have many obligations, including to our communities/society. If most businesses didn't meet those other obligations for the last several hundred years, there would be no community, no market, no technology, and nobody rich enough to buy epipens. You'll notice that most companies are responsible members of their communities to some extent, but there are a few leaches of course who live off everyone else's contributions.
Thanks for this summary comment. This is backed in the literature by people who are systems / usability engineers:
tldr: Reliable design is HUGELY important. You can't just put these things together haphazardly.
"The fact that less than 50% of participants across all devices could follow the labeled instructions without committing a single error provides confirmation that the need for training on the use of epinephrine autoinjectors is still important...The user-centered device design may have a significant impact on correct epinephrine autoinjector use and patient preference."
In the study below, moms of kids with severe allergies were trained to use the EpiPen. Six weeks later in a simulated test, only about two out of five were able to successfully deliver a lifesaving dose of adrenaline.
Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?
You're right. With some Googling, I learned that the FDA does indeed have a "Human Factors Pre-Market Review Process."[1]
But for EpiPen, it seems that the process didn't work, because 60% of consumers apparently can't use the device reliably. I hope that EpiPen is an anomaly, and not typical for FDA-approved lifesaving consumer medical devices.
They should allow reasonably safe products that are among the best available options.
So if people can use an Epipen more reliably than they can prepare an injection, allow it to be marketed. If someone with a history of anaphylaxis is better off with an Epipen than they are with no treatment at all, allow it to be marketed.
> You use the pen, but it fails to work correctly. Who's responsible?
You are responsible for making decisions for yourself. If you think a 3D printed pen is not safe, buy the more expensive one. Don't hedge every decision you make against who you'd be able to sue if it goes wrong.
I rather dislike the (frequently American) immediate viewpoint of assigning blame/responsibility in the case of a failure, and thus who can someone sue. This isn't an uncommon viewpoint at all, rather it seems to be the first that many go to.
Consider this: every time you get into a car, you are putting yourself into life-or-death scenarios that greatly depend on the class and quality of car you've chosen. The government enforces some minimum safety standards for any registered car on the road, but above that, you pay for safety - quite literally.
Does the government prevent the sale of cheaper, inferior cars just because higher-priced cars are substantially safer?
Why should medical devices be any different? If the barriers to entry (e.g., costs associated with FDA approval) were lower, then we'd absolutely have some inferior EpiPens on the market. But we'd also have a lot more options, and all of them (even the best) would be ridiculously cheap compared to what we're seeing now. Wouldn't that be better overall for people who might not be able to afford one at all in the current system?
> The government enforces some minimum safety standards
I think this understates the safety regulations for automobiles by quite a bit. Maybe there's an example of an industry which makes lightly regulated, dangerous products, but I don't think cars are it.
True - the government's automobile safety standards are far from trivial, but there's no denying that the difference in safety between the cheapest smart car on the road and the safest car on the road is huge. In a head-on collision between the two, there's absolutely no contest.
Asking why the government should allow an EpiPen competitor with a 0.1% higher failure rate is akin to asking why the government should allow people to purchase small, cheap cars.
As a road user (walker, cyclist, occasional runner) I consider small vehicles that are easy to see around and above far safer than heavy, bulky vehicles.
Cars aren't designed for the safety of anyone but their occupants, though.
> Cars aren't designed for the safety of anyone but their occupants, though.
This is not the case. Part of the reason that all new cars from large manufacturers are as bulky looking as they are is to conform with US pedestrian collision regulations.
While I applaud this initiative, I'd like to be able to buy a smaller, nimbler car and simply avoid hitting pedestrians.
> there's no denying that the difference in safety between the cheapest smart car on the road and the safest car on the road is huge. In a head-on collision between the two, there's absolutely no contest.
I don't think that's true. Certainly expensive cars have new safety features, but ...
I read a study of empirical data on what, in practice, made cars more survivable in accidents. It was awhile ago but here is my vague memory:
The data was hard to analyze - they were trying to untangle cause and effect from wrecks - but the conclusion was that the most important factor was the relative location of hard points: If their hard point (e.g., bumper) lines up with your soft spot (e.g., driver-side door/window), it's bad for you. That's something that doesn't depend on cost.
Otherwise, I would assume safety depends heavily on weight and structural integrity, and certainly some cheaper vehicles, such as pickup trucks, would be much safer by those measures than much more expensive sedans.
It also might depend on center of gravity, roll-over potential, breaking ability, etc.
I once read someone stating that "The safest car on the road is the one with a ten-inch razor-sharp metal spike fixed to the centre of the steering wheel.".
Yes, but that's mostly because the safest car is more like a suburban tank while the smart car is more like an urban mobility device. If there were no suburban tanks around, the smart car would instantly be much safer.
Firstly, the standards and regulations a manufacturer needs to meet to get even a single car on the road are staggering - probably comparable to FDA approval in complexity. Also, the testing of single components and complete vehicles is extremely comprehensive.
Secondly, there's a huge difference between the two cases that you're not considering: medical devices are designed to interact directly with the human body and alter it from within.
Even though there are cars with a 5-star safety rating, you can still get ones with a 4-star or even 3-star ratings. So I would say the answer to the original question "Does the government prevent you from buying less safe cars" is "No".
In both situations, the government sets a minimum permissible safety standard to sell the product. Medications and medical devices are allowed to kill/injure, but only to a point. Same with cars.
The Government doesn't forbid you, the consumer, from buying questionable cars. It's the manufacturer who is restricted by Government regarding what cars they can sell.
> The Government doesn't forbid you, the consumer, from buying questionable cars.
Yes, they do. There are special regulations around salvage vehicles. Most (all?) states require cars to pass inspection to be on the road. The FTC requires certain disclosures on used cars. WA won't let you sell a post-1964 car - even in a private sale - without seatbelts (http://apps.leg.wa.gov/rcw/default.aspx?cite=46.37.510). etc. etc. etc.
Well, if I can print 3 of them for 1/100th the price of a single one from said manufacturer, if the design is even adequate I'm probably still better off.
What doesn't seem to be represented in the discussion is that if you source and build your own epi pen, you might not have that initial discussion with your doctor and you certainly don't get any medical guidance leaflet with it.
Using an epi pen is a dangerous business and can cause considerable complications. It is absolutely not to be taken lightly and is literally for life-or-death situations. I fear that those making their own (or heaven forbid somebody else's) pen will not know this.
Source: my doctor when I bought my first epi pen (beekeeper).
Semi-yes, semi-no. The epi-pen case is specially made to try and get people to shoot it into themselves/other people correctly. They are super color coded and once triggered can't be untriggered
Other than that, they could be 3-d printed or whatever is cheapest by many providers
Consider also reliability: What if some 3D-printed part breaks? What if it sticks when it gets hot or cold, or after a few hot/cold cycles, or after some flexing in a pocket?
The first 90% of quality is easy ... Think of the difference between the quality needed for a mobile game app and the software that flies airplanes.
If they're significantly cheaper, carry 2 or 3. If you're at a 90% level, you will be almost assured of cheaply having one work, assuming the error/failures are random.
Yes, this is sub-optimal in a life or death situation, but it's a reasonable counter to unreasonably high EpiPen pricing. Moreover, if this becomes common practice or if it's even feared as plausible, it could help reduce EpiPen pricing.
I am allergic to bee stings, myself and, to be honest, I don't agree with you.
The best solution is the one you can actually carry with you – if you can't afford the EpiPen, this system would be far, far better than nothing.
Further, while anaphylaxis is a life threatening situation, it isn't a situation where, if recognized in a timely manner, 10 seconds more to pull out the second or even 3rd home-brew auto-injector would kill the patient.
Next, the widespread existence and feasibility of a home-brew option would itself exert significant pricing pressure on the original EpiPen thereby making it more affordable for everyone and thus less likely that I would even need to actually make one.
Lastly, I would, in fact, use the above hypothesized home-brew option for my kids or wife (if they were alergic), if we couldn't afford an EpiPen or as a way of making sure we always had one available.
As I argued, having multiple devices cheaply on hand makes failure of one an okay thing. If they have a 10% failure rate (which itself is a high failure rate even for this scenario), having 3 on hand would mean you'd have one-tenth of one percent odds of all three failing. Add a 4th and you get down to 0.01% – get the individual reliability down to 5% failure rate and 3 devices would give you 0.0125% odds of failure. Those are actually pretty good odds. Moreover, I'm not sure what the traditional EpiPen's reliability is, but I'd bet it's not that much better than a 0.000125 failure rate.
Liability isn't (shouldn't be) the first concern in health discussions. Presuming an individual cannot afford the $600 version, surely the chance that a printed version might work is purely an improvement in their situation.
On the other hand, it doesn't have to work 100% of the time to be viewed as a threat, economically. Make it widespread, make it reasonably effective and you will likely succeed in driving the price of the certified EpiPen.
Some discussions:
https://www.reddit.com/r/news/comments/4y5481/cost_of_epipen...
https://www.reddit.com/r/3Dprinting/comments/4y7f26/epipen_f...