EpiPen Price Rise Sparks Concern for Allergy Sufferers(well.blogs.nytimes.com)
well.blogs.nytimes.com
EpiPen Price Rise Sparks Concern for Allergy Sufferers
http://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/
359 comments
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.
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.
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.
Not so much fixed as "Canada doesn't insist that everyone make separate deals so everyone can get fucked harder".
It turns out when you have millions of people dealing together as a block, they have much more bargaining power.
It turns out when you have millions of people dealing together as a block, they have much more bargaining power.
That's not why Canada gets better prices. United Healthcare has 42M members which is bigger than the entire population of Canada.
Yes, apparently Canada has something called the Patented Medicine Prices Review Board:
http://pmprb-cepmb.gc.ca/about-us/frequently-asked-questions
http://pmprb-cepmb.gc.ca/about-us/frequently-asked-questions
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.
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.
I agree. My hack is safer than 3D printing medical devices, as its simply a geographical arbitrage.
Thank you Canada.
Thank you Canada.
Well the cheaper and more effective solution would be to carry around a syringe and a small bottle of epinephrine.
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.
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.
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.
It's recommended to seek medical attention immediately after using any epinephrine injection.
There's a pretty fair chance that you driving your living father home from the emergency room is evidence of the injection working.
There's a pretty fair chance that you driving your living father home from the emergency room is evidence of the injection working.
Surely design files can be signed...
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).
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).
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?
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.
Not condoning this behavior at all, but don't we see this with the lack of equal access to drugs all the time? :(
It seems especially egregious when we are talking about a dispenser versus the drug itself.
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.
> 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.
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'.
> 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.
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.
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.
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.
> how exactly the 'free-market' for medical supplies would work without regulation, just look at the 1800s.
Do you have a source for this? Medical costs started angling up steeply in the 1960s with the advent of heavy regulation.
> dumping were still more profitable than competing on price.
Isn't dumping competing on price?
Do you have a source for this? Medical costs started angling up steeply in the 1960s with the advent of heavy regulation.
> dumping were still more profitable than competing on price.
Isn't dumping competing on price?
> 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.
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.
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 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.
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.
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.
> 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.
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.
So you're saying that Petroleum Exporting Countries would never say... create an Organization intended to increase the price of oil?
How does that help your case? The members of that organization are governments, not companies. OPEC is regulation.
How does that help your case? The members of that organization are governments, not companies. OPEC is regulation.
I'm curious why people are downvoting this.
In the software business, with pretty much zero regulations, competition has run the price literally to $0 for broad swaths of products.
> 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.
This has been the driving force in the price of software for decades: http://www.joelonsoftware.com/articles/StrategyLetterV.html
And it's true today. The biggest contributor to Linux is... Intel. Because it sells hardware. Google gives you a free browser so it can sell ad space.
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.
This has been the driving force in the price of software for decades: http://www.joelonsoftware.com/articles/StrategyLetterV.html
And it's true today. The biggest contributor to Linux is... Intel. Because it sells hardware. Google gives you a free browser so it can sell ad space.
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 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.
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.
>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!
Of course, I'm not providing any citations myself!
Food is necessary for life, but food (in the US) is cheap, and food prices are not regulated.
There is also no government protected monopoly on food (although not for lack of trying).
People don't like the idea of putting a price on their health.
They don't like it, but healthcare costs money and money is a limited resource. That's reality.
In the US system it's the insurance companies that limit access (or the cost to an individual). In other countries it's the gov't.
They don't like it, but healthcare costs money and money is a limited resource. That's reality.
In the US system it's the insurance companies that limit access (or the cost to an individual). In other countries it's the gov't.
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.
Yep. :(
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.)
[0]: https://www.theguardian.com/commentisfree/2016/aug/13/estrog...
[1]: http://www.out.com/out-exclusives/2016/8/04/exclusive-theres...
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.)
[0]: https://www.theguardian.com/commentisfree/2016/aug/13/estrog...
[1]: http://www.out.com/out-exclusives/2016/8/04/exclusive-theres...
One of the reasons for drug shortages is because it's just not profitable to produce the drugs when you roll in all the regulatory costs.
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] 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.
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.
(2) is a myth: http://www.nytimes.com/roomfordebate/2015/04/16/what-are-cor...
(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.
(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).
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.
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.
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.
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.
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.
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.
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.
Sure, we mostly stopped doing this for various stupid reasons, but legally it's sill an option.
When was this done, and how did it go?
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.
Generally ownership is short lived though.
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.
Generally ownership is short lived though.
So, we have:
- Seizing companies literally run by criminal organizations.
- A single time during war when companies were nationalized, and which was then ruled "an unconstitutional abuse of presidential power".
- A bailout of the shareholders and creditors of failed companies.
The only relevant one seems to be the second, and the outcome in the courts doesn't sound promising.
- Seizing companies literally run by criminal organizations.
- A single time during war when companies were nationalized, and which was then ruled "an unconstitutional abuse of presidential power".
- A bailout of the shareholders and creditors of failed companies.
The only relevant one seems to be the second, and the outcome in the courts doesn't sound promising.
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.
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.
Supply and demand amiright? Otherwise we might be branded as gasp socialists!
There really isn't any good answer to this, and there will be losers in either scenario.
There really isn't any good answer to this, and there will be losers in either scenario.
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.
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.
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."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2892620/
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."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2892620/
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?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/
Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial. Allergy. 2015 Jul; 70(7): 855–863.
Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4654245/
Patients’ ability to treat anaphylaxis using adrenaline autoinjectors: a randomized controlled trial. Allergy. 2015 Jul; 70(7): 855–863.
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.
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.
Shouldn't the FDA require that manufacturers provide evidence that consumer medical devices can be used reliably for their intended purpose?
What makes you think the FDA doesn't require this?
What makes you think the FDA doesn't require this?
The fact that three out of five people trained to use this lifesaving product weren't able to.
That doesn't mean the FDA doesn't ask for data.
I have a friend who works in the industry and it's his job to run usability trials for medical devices. The FDA won't approve a device without it.
I have a friend who works in the industry and it's his job to run usability trials for medical devices. The FDA won't approve a device without it.
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.
[1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
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.
[1] http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
> 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.
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 was going to reply and say this, but you said it first :)
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.
Responsibility (blame) is not the same thing as "who can I sue?"
For one thing, finding the source of the problem, or whatever warped thought process resulted in it, is a good place to start fixing things.
For one thing, finding the source of the problem, or whatever warped thought process resulted in it, is a good place to start fixing things.
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?
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?
> Does the government ban us from purchasing cheaper, inferior cars just because higher-priced cars are substantially safer?
Yes?
Yes?
But also no, I can be a used car with lower safety features than mandated for new cars I believe
Yes, and you can use an expired or recalled medication. I'm not sure how that's relevant.
The used car will also need to pass an annual safety inspection here in NY, at least, as it's required to meet some minimum safety standards.
The used car will also need to pass an annual safety inspection here in NY, at least, as it's required to meet some minimum safety standards.
In that case, there is no ambiguity when it comes to determining who's responsible, unless the DMV or whoever allowed you to drive it.
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.
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.
> 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.
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.
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.
> 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.
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 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.
gun industry
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.
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.
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).
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
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.
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.
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.
> this is sub-optimal in a life or death situation
I think that rules it out. Imagine a family member, or anyone, dying because of your sub-optimal solution.
I think that rules it out. Imagine a family member, or anyone, dying because of your sub-optimal solution.
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.
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.
Sounds like an opportunity for a startup...
I think it's patented so yeah but no...?
Meanwhile, in single-payer Britain the NHS pays £26 ($35).
https://www.evidence.nhs.uk/formulary/bnfc/current/3-respira...
https://www.evidence.nhs.uk/formulary/bnfc/current/3-respira...
Even at retail (i.e. just walk into pharmacy with your prescription and buy it like you'd buy a coffee) they are £50 per pen/£90 for two [1] ($66/$118 at today's USD-GBP rate)
The weird healthcare system in the US is one of the main reasons I've resisted calls to relocate there for work. Stories like this are just really off putting.
1 - https://onlinedoctor.lloydspharmacy.com/uk/allergy/epipen
The weird healthcare system in the US is one of the main reasons I've resisted calls to relocate there for work. Stories like this are just really off putting.
1 - https://onlinedoctor.lloydspharmacy.com/uk/allergy/epipen
You know what's weird about this situation is that often I've been told by people here in the US that the price NHS and other single payer systems pay is only possible because we here in the US supposedly pay for it at the free market price. I don't believe that myself since it wouldn't make much sense to say that the prices would plummet to such a degree as to be unprofitable. But I do wonder how much of the price would be affected if every country in the world were under single payer systems. Would it be even marginally higher? Would it be possibly lower for all? I'm not sure. But I would love to see someone analyze this to see if this is statement I keep hearing is 100% bunk.
> we here in the US supposedly pay for it at the free market price
The free market price system does not work in American healthcare because we do not have a free market. Healthcare is one of the most heavily regulated industries and the third-party payment system means that consumers are divorced from the price mechanism.
The free market price system does not work in American healthcare because we do not have a free market. Healthcare is one of the most heavily regulated industries and the third-party payment system means that consumers are divorced from the price mechanism.
As a consumer of epipens, I can assure you that we are not divorced from the price mechanism. We are talking about $300+ a unit for a dispenser (the drug itself costs pennies). The time needed for competition to manifest in the market will cause much suffering.
It is possible that both can be true. The price for medicine is cheaper because you have a single entity, the NHS, negotiating for a large group of people. On the the other hand, it is possible that we subsidize the development of new medicine to an extent. An epipen would otherwise exist regardless because it is a requirement for many people. More advanced medicine that requires a large capital investment for research and development could be another story.
> The price for medicine is cheaper because you have a single entity, the NHS, negotiating for a large group of people.
Wellpoint and its subsidiaries insure more than 70 million people, which is slightly more than the current population of the UK.
https://www.thebalance.com/the-big-five-health-insurance-com...
Wellpoint and its subsidiaries insure more than 70 million people, which is slightly more than the current population of the UK.
https://www.thebalance.com/the-big-five-health-insurance-com...
You can be sure that Wellpoint has also negotiated a good rate on Epi-pens. This price-gouging affects people who don't have prescription drug coverage or those who are enrolled in HSA plans that force you to pay for the first few thousand dollars worth of prescriptions at retail prices. And there are a lot of people being funnelled into HSAs by their employers.
My children have a need for epipens. With our insurance, it is still prohibitively expensive. After hearing about the cost in GB, I'm considering making a trip to London to stock up
Their negotiating position is probably limited by the fact they can't say that they just won't buy it. NICE evaluates all treatments bought by the NHS for value for money. If it was too expensive they'd just not buy it. It's not like there are no alternatives.
Actually, the big problem in the US is that there are no alternatives. The last Mylan competitor making a similar product folded six months ago. If you want to blame anything about the US system for the current situation, blame the regulatory capture that is generic drug approval.
What does the NHS do about drugs that are sole source?
What does the NHS do about drugs that are sole source?
Insurance companies are consistently profitable, it's hard to look at that profit as anything other than a net drain. Especially when a public healthcare option was not included in the US specifically because these companies could not compete.
Looking at direct and indirect costs insurance adds ~20+% to healthcare spending. Remember insurance commercials for example are yet another cost.
Looking at direct and indirect costs insurance adds ~20+% to healthcare spending. Remember insurance commercials for example are yet another cost.
"Unfortunately this site is only available from Great Britain." - but the Google Cache works: https://webcache.googleusercontent.com/search?q=cache%3Ahttp...
Same thing with Asthma inhalers.
http://www.nytimes.com/2013/10/13/us/the-soaring-cost-of-a-s...
http://www.nytimes.com/2013/10/13/us/the-soaring-cost-of-a-s...
Damned socialists. They need some free-market goodness over there!
B-b-but socialism!
Someone might reasonably wonder why a federal task force is required to investigate "price gouging" for an item that contains under $10 of materials and is not mechanically complex.
Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan?
We're told to hate the Martin Shkrelis of the world, and to resend the Mylans, but the truth is that our system prevents price competition because it is designed to protect established firms. This is why many established firms and "industry leaders" strongly supported the affordable care act.
Why wouldn't an entrepreneur simply introduce a competing epi-pen design and bring it to market for $300 (for example) and undercut the price being charged by Mylan?
We're told to hate the Martin Shkrelis of the world, and to resend the Mylans, but the truth is that our system prevents price competition because it is designed to protect established firms. This is why many established firms and "industry leaders" strongly supported the affordable care act.
The government has created a moat for the current pen through regulation, particularly the extensive testing needed to bring it to market as a medical device whom people's lives depend on it delivering the right dosage with a low failure rate.
This creates something of a small granted monopoly.
It makes sense for the government to step in when something goes wrong.
There are lots of theoretical arguments for a freer market that may drain that moat and allow competitors to quickly react to gouging but the reality is that consumers don't have a great way to test things like epipens and a market trial and error approach seems a little barbaric.
This creates something of a small granted monopoly.
It makes sense for the government to step in when something goes wrong.
There are lots of theoretical arguments for a freer market that may drain that moat and allow competitors to quickly react to gouging but the reality is that consumers don't have a great way to test things like epipens and a market trial and error approach seems a little barbaric.
> a market trial and error approach seems a little barbaric.
The average American earns less in a week than the cost of one epi pen. No, "nonfarm" statistics don't apply since people who work on farms still need epi pens.
> It makes sense for the government to step in when something goes wrong.
What has gone wrong in this case? The protected cronies of regulators are making a tidy profit after spending years cozying up, making political donations, and building a revolving door between industry and government.
In actuality, in this case everything has gone abundantly right for regulators and firms. The task force will likely warn them that they should have just been satisfied with $350 per pen to avoid the bad press.
The average American earns less in a week than the cost of one epi pen. No, "nonfarm" statistics don't apply since people who work on farms still need epi pens.
> It makes sense for the government to step in when something goes wrong.
What has gone wrong in this case? The protected cronies of regulators are making a tidy profit after spending years cozying up, making political donations, and building a revolving door between industry and government.
In actuality, in this case everything has gone abundantly right for regulators and firms. The task force will likely warn them that they should have just been satisfied with $350 per pen to avoid the bad press.
So, what is the market solution? All I see is a restatement of the problem.
There is no market solution because it's not a market problem. If you try to make your own epi pen and sell it, the nice men with guns come and take you to jail. Literally.
Are there any cases of a small company attempting this? Since the drug is well known and cheap, I was hoping to read about hackers designing an open source 3D printed dispenser.
It's not necessarily an all-or-nothing solution.
Consumers value accurate information about drug safety, so there is abundant incentive for a wide variety of different groups to offer a list of safe drugs.
Since most Americans also interface with a private health insurance company and often private medical groups or hospitals, it's not just the individual who determines which safe list to trust.
For example:
Ronald's cardiologist might trust a safe list produced by a professional organization of cardiologists. Ronald's wife may be from the UK and trust the UK's trusted list. Ronald may be a customer of Aetna which may use its own list.
If Ronald is prescribed a particular drug, he can verify that it's listed on any lists he cares about. Perhaps he's recently gotten interested in Anti-Vaxer lore, and the drug is blacklisted by his group. He can go back to his doc and request another option. The same would happen if Aetna hasn't added the drug to its formulary (for whatever reason).
Ronald may also be cost conscious and may also have a safe list of highly economical drugs, and may ask his doctor about the implications of choosing a far less expensive option that was popular in the 1970s. This drug may have been removed from Aetna's list due to influence from the pharma industry, but Ronald and his doctor can look at the available information and make an informed decision.
With pharmaceuticals we're talking about a very simple blacklisting or whitelisting scheme. Most well-known drugs are quite well understood. The "important" area for making the white listing (or blacklisting) decision lies mostly with brand new drugs. It's silly to think that a single entity can somehow merge the interests of young and old and derive a safe period of time for a drug to stay off the market. It's also important to recognize the intense pressure on regulators not to pull a drug that has already been approved and whose side effects may be a bit worse than initially understood (such as Vioxx).
So in a broad sense, the key is decentralization, to make corruption more costly, and focusing our trust at the local level to the docs who we trust with our care who can make an informed decision guided by whitelist/blacklist offerings from a variety of sources.
Consumers value accurate information about drug safety, so there is abundant incentive for a wide variety of different groups to offer a list of safe drugs.
Since most Americans also interface with a private health insurance company and often private medical groups or hospitals, it's not just the individual who determines which safe list to trust.
For example:
Ronald's cardiologist might trust a safe list produced by a professional organization of cardiologists. Ronald's wife may be from the UK and trust the UK's trusted list. Ronald may be a customer of Aetna which may use its own list.
If Ronald is prescribed a particular drug, he can verify that it's listed on any lists he cares about. Perhaps he's recently gotten interested in Anti-Vaxer lore, and the drug is blacklisted by his group. He can go back to his doc and request another option. The same would happen if Aetna hasn't added the drug to its formulary (for whatever reason).
Ronald may also be cost conscious and may also have a safe list of highly economical drugs, and may ask his doctor about the implications of choosing a far less expensive option that was popular in the 1970s. This drug may have been removed from Aetna's list due to influence from the pharma industry, but Ronald and his doctor can look at the available information and make an informed decision.
With pharmaceuticals we're talking about a very simple blacklisting or whitelisting scheme. Most well-known drugs are quite well understood. The "important" area for making the white listing (or blacklisting) decision lies mostly with brand new drugs. It's silly to think that a single entity can somehow merge the interests of young and old and derive a safe period of time for a drug to stay off the market. It's also important to recognize the intense pressure on regulators not to pull a drug that has already been approved and whose side effects may be a bit worse than initially understood (such as Vioxx).
So in a broad sense, the key is decentralization, to make corruption more costly, and focusing our trust at the local level to the docs who we trust with our care who can make an informed decision guided by whitelist/blacklist offerings from a variety of sources.
Do we really expect every person to conduct such personal research for every single treatment to every single ailment they have? I don't consider that a reasonable solution.
It would be more of a checklist. Chances are there would not be much disagreement. Tylenol, for example, is likely to be whitelisted by nearly any list maker.
The scenarios where there was a mix of approval and disapproval probably do warrant taking some extra time, yet few of us are able to do it today because we assume (falsely) that just because something is approved by the FDA it is safe (or unsafe if not approved).
Effectiveness is a whole different question, and many drugs with significant side-effects do not do better than the placebo effect for some of their approved uses.
The scenarios where there was a mix of approval and disapproval probably do warrant taking some extra time, yet few of us are able to do it today because we assume (falsely) that just because something is approved by the FDA it is safe (or unsafe if not approved).
Effectiveness is a whole different question, and many drugs with significant side-effects do not do better than the placebo effect for some of their approved uses.
How would one vet which lists are "true" and which lists can be "sponsored"? What would prevent corps from taking their lobbying money and simply directing it at list makers? How would the non-sponsored lists make their money?
Thank you. This is a problem that starts and ends with government, not with the "free market" (which hasn't existed in the healthcare industry in a long time)
The problem is how does the free market test these kinds of things when there is every incentive to cut corners? We're not talking about toasters. How many people have to die before the market reacts? How much research into individual company's testing should a person do in order to buy an epipen?
Let's talk about a free market.
> every incentive to cut corners
Do you continue to patronize businesses that cut corners when you expect good customer service or a good product?
The free market ruthlessly punishes businesses that do not meet consumer demands. Only through government interference are substandard businesses sustained. Profits are the signal that a business is doing something right.
Ok, but the EpiPen is a life-or-death product. We must have coercive government regulation, right?
> How many people have to die
As far as a quick search could turn up, it looks like the discovery and isolation of epinephrine was entirely the product of private ingenuity -- in 1901. Government did not have some large project to find this wonder compound that could save lives. So private initiative already has saved countless lives without the direction of the government.
So here is a compound that has been around for 115 years, and somehow we're looking at $600 for a two-pack of injectors. There is no way that situation arises from free-market processes. Government has been heavily involved in healthcare for a while, granting monopoly privilege to favored parties, effectively eliminating competition.
Additionally, if a company sells a product purporting to save your life in a dire situation, shouldn't they be held liable if their product doesn't work? Not only will people cease to trust said company (forcing them out of business) but competitors will also arise -- and survive -- based on how well they serve consumers.
> every incentive to cut corners
Do you continue to patronize businesses that cut corners when you expect good customer service or a good product?
The free market ruthlessly punishes businesses that do not meet consumer demands. Only through government interference are substandard businesses sustained. Profits are the signal that a business is doing something right.
Ok, but the EpiPen is a life-or-death product. We must have coercive government regulation, right?
> How many people have to die
As far as a quick search could turn up, it looks like the discovery and isolation of epinephrine was entirely the product of private ingenuity -- in 1901. Government did not have some large project to find this wonder compound that could save lives. So private initiative already has saved countless lives without the direction of the government.
So here is a compound that has been around for 115 years, and somehow we're looking at $600 for a two-pack of injectors. There is no way that situation arises from free-market processes. Government has been heavily involved in healthcare for a while, granting monopoly privilege to favored parties, effectively eliminating competition.
Additionally, if a company sells a product purporting to save your life in a dire situation, shouldn't they be held liable if their product doesn't work? Not only will people cease to trust said company (forcing them out of business) but competitors will also arise -- and survive -- based on how well they serve consumers.
>The free market ruthlessly punishes businesses that do not meet consumer demands.
True. But only as ruthlessly as the market approaches the free market ideal (readily available and accurate information on products, other users, choice at time of purchase etc). And we know there are no true free markets and that markets can drift far from the ideal even absent of government interference.
Who is the first to try out a newly released epipen?
>Only through government interference are substandard businesses sustained.
Now THAT is a very strong statement. Information asymmetry that has nothing to do with government is one category of ways a sub-standard business can thrive. Are we to believe that information asymmetry is all rooted in government interference?
> Profits are the signal that a business is doing something right.
Most of the time. An abundance of sustained profits is also a signal that the business is doing something wrong (or taking advantage of a market failure of some kind) or competitors would be jumping in and eating away at them.
True. But only as ruthlessly as the market approaches the free market ideal (readily available and accurate information on products, other users, choice at time of purchase etc). And we know there are no true free markets and that markets can drift far from the ideal even absent of government interference.
Who is the first to try out a newly released epipen?
>Only through government interference are substandard businesses sustained.
Now THAT is a very strong statement. Information asymmetry that has nothing to do with government is one category of ways a sub-standard business can thrive. Are we to believe that information asymmetry is all rooted in government interference?
> Profits are the signal that a business is doing something right.
Most of the time. An abundance of sustained profits is also a signal that the business is doing something wrong (or taking advantage of a market failure of some kind) or competitors would be jumping in and eating away at them.
> markets can drift far from the ideal even absent of government interference
But only government interference can lock the market in that state in perpetuity, eliminating the corrective forces of price and competition.
> Are we to believe that information asymmetry is all rooted in government interference?
Of course not. But businesses that are able to satisfy more consumers through better transparency are going to win market share and increase profits.
Asymmetry exists in most business situations though. That's the whole point of specialization in the economy: some people have greater knowledge, skill, or training in a certain area and are able to provide more value to the consumer. It is worthwhile for the consumer to trade money in exchange for the specialized service rather than spending years to learn that craft to perform the service herself.
The cornerstone of the free market is satisfying consumer demand. Firms that fail to do so are destroyed quickly and effectively when the consumer stops purchasing their product.
> abundance of sustained profits is also a signal that the business is doing something wrong
What? Please explain.
But only government interference can lock the market in that state in perpetuity, eliminating the corrective forces of price and competition.
> Are we to believe that information asymmetry is all rooted in government interference?
Of course not. But businesses that are able to satisfy more consumers through better transparency are going to win market share and increase profits.
Asymmetry exists in most business situations though. That's the whole point of specialization in the economy: some people have greater knowledge, skill, or training in a certain area and are able to provide more value to the consumer. It is worthwhile for the consumer to trade money in exchange for the specialized service rather than spending years to learn that craft to perform the service herself.
The cornerstone of the free market is satisfying consumer demand. Firms that fail to do so are destroyed quickly and effectively when the consumer stops purchasing their product.
> abundance of sustained profits is also a signal that the business is doing something wrong
What? Please explain.
>But only government interference can lock the market in that state in perpetuity, eliminating the corrective forces of price and competition.
Again a very strong statement with only faith that government is bad to back it up. Market power can become dominant in such a way that it can lock market distortions in as well. See: monopoly
>But businesses that are able to satisfy more consumers through better transparency are going to win market share and increase profits.
What about businesses that poison the environment in secret? This is also an information asymmetry that can exist that will earn greater profits right up until they are caught, if that day ever comes. I was using information asymmetry as one unavoidable aspect of pure markets that can lead to severe distortions completely apart from any kind of government interference since you asserted that only the government can sustain negative market distortions.
>> abundance of sustained profits is also a signal that the business is doing something wrong >What? Please explain.
If there is a great profit being made in a theoretical market approaching perfection then theory says competitors will enter that market, chipping away at that enormous profit until it is at a level that is still profitable but only so much as it is not worth it to further competitors to enter that market to capture even more. In other words, in a well functioning market profits tend toward (but never reach) zero.
If this is true then an abundant profit sustained over time is an aberration and evidence that the business is doing something wrong in terms of the health of the market (threatening or buying off potential competitors, for example).
Again a very strong statement with only faith that government is bad to back it up. Market power can become dominant in such a way that it can lock market distortions in as well. See: monopoly
>But businesses that are able to satisfy more consumers through better transparency are going to win market share and increase profits.
What about businesses that poison the environment in secret? This is also an information asymmetry that can exist that will earn greater profits right up until they are caught, if that day ever comes. I was using information asymmetry as one unavoidable aspect of pure markets that can lead to severe distortions completely apart from any kind of government interference since you asserted that only the government can sustain negative market distortions.
>> abundance of sustained profits is also a signal that the business is doing something wrong >What? Please explain.
If there is a great profit being made in a theoretical market approaching perfection then theory says competitors will enter that market, chipping away at that enormous profit until it is at a level that is still profitable but only so much as it is not worth it to further competitors to enter that market to capture even more. In other words, in a well functioning market profits tend toward (but never reach) zero.
If this is true then an abundant profit sustained over time is an aberration and evidence that the business is doing something wrong in terms of the health of the market (threatening or buying off potential competitors, for example).
> See: monopoly
Please. Even in the classic case of Standard Oil, they lost massive amounts of market share even before the government started interfering in their business.
According to Wikipedia:
> What about businesses that poison the environment in secret?
If we had property in the air and water, then if business harms your property, you have recourse against them. As it stands, the air and water are unowned, which means that they are a permanent tragedy of the commons.
As to your ideas about perfect market competition, etc: real markets are dynamic and vibrant, with new technology disrupting old ways of doing business and new consumer preferences forcing business to adjust. That's fine if some theoretical market theory says in equilibrium, profits tend toward zero, but we live in the real world, so that will never be the case with free markets.
Please. Even in the classic case of Standard Oil, they lost massive amounts of market share even before the government started interfering in their business.
According to Wikipedia:
In 1904, Standard controlled 91 percent of production and
85 percent of final sales. [...] Due to competition from
other firms, their market share had gradually eroded to 70
percent by 1906 which was the year when the antitrust case
was filed against Standard, and down to 64 percent by 1911
when Standard was ordered broken up and at least 147 refining
companies were competing with Standard including Gulf, Texaco,
and Shell. It did not try to monopolize the exploration and
pumping of oil (its share in 1911 was 11 percent).
> What about businesses that poison the environment in secret?
If we had property in the air and water, then if business harms your property, you have recourse against them. As it stands, the air and water are unowned, which means that they are a permanent tragedy of the commons.
As to your ideas about perfect market competition, etc: real markets are dynamic and vibrant, with new technology disrupting old ways of doing business and new consumer preferences forcing business to adjust. That's fine if some theoretical market theory says in equilibrium, profits tend toward zero, but we live in the real world, so that will never be the case with free markets.
So, the free market where it fits your narrative of the evils of intervention and real markets where your free market narrative breaks down. If you follow your last real market argument a little further, you'll find my positions.
> Do you continue to patronize businesses that cut corners when you expect good customer service or a good product?
Do you have cable and/or phone service? Would we be using Comcast or AT&T if monopolies or regional monopolies didn't make them the only choices? Monopolies that were enabled through government inaction, by the way, not through government enabling. [1]
> The free market ruthlessly punishes businesses that do not meet consumer demands. Only through government interference are substandard businesses sustained. Profits are the signal that a business is doing something right.
There's always going to be the problem of information asymmetry. Most people don't have the time to read Consumer Reports, go through the research of what brands cut corners and which don't, and do the cost-benefit calculation of picking quality vs. price.
I don't think government interference is somehow propping up the fast food industry, or bad policies from Comcast.
[1] https://news.ycombinator.com/item?id=2709834
Do you have cable and/or phone service? Would we be using Comcast or AT&T if monopolies or regional monopolies didn't make them the only choices? Monopolies that were enabled through government inaction, by the way, not through government enabling. [1]
> The free market ruthlessly punishes businesses that do not meet consumer demands. Only through government interference are substandard businesses sustained. Profits are the signal that a business is doing something right.
There's always going to be the problem of information asymmetry. Most people don't have the time to read Consumer Reports, go through the research of what brands cut corners and which don't, and do the cost-benefit calculation of picking quality vs. price.
I don't think government interference is somehow propping up the fast food industry, or bad policies from Comcast.
[1] https://news.ycombinator.com/item?id=2709834
> Do you have cable and/or phone service?
The terrible state of internet service providers is not a free-market phenomenon. Those industries matured over a long period of time hand-in-hand with governments and regulators. Through bidding processes, licenses, and overt monopolies, government has heavily influenced the shape of those industries today. Taking a broken system and "deregulating" it doesn't magically get you awesome results, if the very fabric of that system was built on government privilege and control.
If government wants to take some action now that can undo what it has done in the past regarding the ISPs, then I'm all for it.
> There's always going to be the problem of information asymmetry.
Even if I grant you that point -- but see sibling comment -- wouldn't it be nice if that were the only problem in the market? Wouldn't it be nice if there were no government-granted monopolies? Uber vs the taxis is the perfect example of what's wrong with cronyism and government privilege.
> propping up the fast food industry
Consumers are propping it up, because it meets the need for cheap, tasty food. Sure it's bad for you, but people know that and don't care. Doing drugs is bad for you -- and illegal to boot -- and plenty of people use them. I don't prefer a government that dictates what sorts of things I put in my body of my own free will.
The terrible state of internet service providers is not a free-market phenomenon. Those industries matured over a long period of time hand-in-hand with governments and regulators. Through bidding processes, licenses, and overt monopolies, government has heavily influenced the shape of those industries today. Taking a broken system and "deregulating" it doesn't magically get you awesome results, if the very fabric of that system was built on government privilege and control.
If government wants to take some action now that can undo what it has done in the past regarding the ISPs, then I'm all for it.
> There's always going to be the problem of information asymmetry.
Even if I grant you that point -- but see sibling comment -- wouldn't it be nice if that were the only problem in the market? Wouldn't it be nice if there were no government-granted monopolies? Uber vs the taxis is the perfect example of what's wrong with cronyism and government privilege.
> propping up the fast food industry
Consumers are propping it up, because it meets the need for cheap, tasty food. Sure it's bad for you, but people know that and don't care. Doing drugs is bad for you -- and illegal to boot -- and plenty of people use them. I don't prefer a government that dictates what sorts of things I put in my body of my own free will.
> The problem is how does the free market test these kinds of things when there is every incentive to cut corners?
The same incentive that makes the iPhone or Model S such poor quality?
We don't know the name of the epi pen manufacturer because it does not need to develop a brand reputation, all it needs to do is reach a deal with regulators and collect profits.
There is much room for a combination of public and self-interested private watchdog groups. There is no reason why we must rely on only one quality control approach.
If things go poorly it can simply sell the patent to another firm who can repeat the same strategy, the only risks being that someone will come up with a better treatment or that regulators will take a dislike to the company... The second of these risks can be reduce through revolving door strategies and the standard regimen of fancy meals, etc.
The same incentive that makes the iPhone or Model S such poor quality?
We don't know the name of the epi pen manufacturer because it does not need to develop a brand reputation, all it needs to do is reach a deal with regulators and collect profits.
There is much room for a combination of public and self-interested private watchdog groups. There is no reason why we must rely on only one quality control approach.
If things go poorly it can simply sell the patent to another firm who can repeat the same strategy, the only risks being that someone will come up with a better treatment or that regulators will take a dislike to the company... The second of these risks can be reduce through revolving door strategies and the standard regimen of fancy meals, etc.
Our entire medical system was founded as a reaction against snake oil salesmen and quacks who preyed on desperate people. If you support capitalism and the free market in medicine, you must acknowledge that monopolies can and do arise.
Seems to me that less testing is necessary for an established product.
Are there patents involved?
Are there patents involved?
Sure, any company wishing to enter the market can use the expired patent as a reference.
It looks like there's a minefield of patents granted post-1995[0]; and so which enjoy a 20-year term of protection.
I can't see why any protection is necessary.
0: https://news.ycombinator.com/item?id=12344059
I can't see why any protection is necessary.
0: https://news.ycombinator.com/item?id=12344059
Even if previous designs are followed, there are questions of materials and construction that need a significant amount of testing.
First: I don't disagree with you about price gouging and the need for a solution. i spend time awake at night thinking about it.
Considering COGS in Biologics drugs pricing is a logical fallacy. The $10 is irrelevant. You have to amortize in all the time, and expenses required to establish a sterile fill and finish facility, or the required capacity of a new product in an existing facility. A reasonable accountant would also probably throw in some of expense for the patent lawyers generic firms have in legion, or R&D pharma has. Maintain a large amount of sterile injectable manufacturing capacity at "drop-of-the-hat" availability to absorb/profit from such market fluctions at low pricing? Not a business model anybody would fund, or would keep someone employed in pharma. Does that justify the new price, probably not. Does it make a $300 pen a great business plan? Probably not. Hopefully that changes as the parasitic business models of the Valeants and Skrelli's of the world are receive due scrutiny.
Considering COGS in Biologics drugs pricing is a logical fallacy. The $10 is irrelevant. You have to amortize in all the time, and expenses required to establish a sterile fill and finish facility, or the required capacity of a new product in an existing facility. A reasonable accountant would also probably throw in some of expense for the patent lawyers generic firms have in legion, or R&D pharma has. Maintain a large amount of sterile injectable manufacturing capacity at "drop-of-the-hat" availability to absorb/profit from such market fluctions at low pricing? Not a business model anybody would fund, or would keep someone employed in pharma. Does that justify the new price, probably not. Does it make a $300 pen a great business plan? Probably not. Hopefully that changes as the parasitic business models of the Valeants and Skrelli's of the world are receive due scrutiny.
Your point about R&D is valid, but in this case epi was first synthesized in 1895 and the R&D cost has long since been amortized and the IP is in the public domain.
http://www.patent-invent.com/adrenaline_patent.html
This article suggests that it was in fact a very shrewd business plan:
http://www.bloomberg.com/news/articles/2015-09-23/how-market...
http://www.patent-invent.com/adrenaline_patent.html
This article suggests that it was in fact a very shrewd business plan:
http://www.bloomberg.com/news/articles/2015-09-23/how-market...
The relevant IP isn't the active pharmaceutical ingredient but the formulation and delivery method, and that appears to be out to 2035.
http://www.accessdata.fda.gov/scripts/cder/ob/results_produc...
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cf...
I agree it's a good business plan as a solo participant in the market, but as a second or third entrant, probably less so-- depending on IP around the formulation and delivery method. With the number of company with discontinued products in the Orange book, i suspect there is some economic burden.
that said there seems to be therapeptic equivalents available http://www.parsterileproducts.com/products/products/adrenali... so unless there is collusion, or a supply constraint, i'm not sure why the price will stand in the long term.
(also is don't have expertise in this specific disease/drug so my comments could all be wrong).
EDIT: i just realized i put int he IP links for PAR Pharma's product... i'm not sure what mylan's protection is but i have to get to work....)
http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cf...
I agree it's a good business plan as a solo participant in the market, but as a second or third entrant, probably less so-- depending on IP around the formulation and delivery method. With the number of company with discontinued products in the Orange book, i suspect there is some economic burden.
that said there seems to be therapeptic equivalents available http://www.parsterileproducts.com/products/products/adrenali... so unless there is collusion, or a supply constraint, i'm not sure why the price will stand in the long term.
(also is don't have expertise in this specific disease/drug so my comments could all be wrong).
EDIT: i just realized i put int he IP links for PAR Pharma's product... i'm not sure what mylan's protection is but i have to get to work....)
> i'm not sure why the price will stand in the long term.
I think the system we have leads to partial collusion, since all firms have an incentive to keep prices high and share the market two or three ways. If there were 30 or 40 pharma companies competing it would be a different story.
I think the system we have leads to partial collusion, since all firms have an incentive to keep prices high and share the market two or three ways. If there were 30 or 40 pharma companies competing it would be a different story.
For anyone as confused as I was, I'm presuming that, Michael Skakels=Martin Shkreli?
But to be clear, it was the established firms that designed the system to protect established firms.
There's a $150 alternative available.
http://www.goodrx.com/adrenaclick
http://www.goodrx.com/adrenaclick
It's an alternative that a) requires a doctor to specifically prescribe and b) is not covered by most insurance plans. There is a good reason the articles on this subject are saying there are currently no alternatives, since there were drop-in replacements until earlier this year.
It's still obviously a reasonable substitute for (at least some) patients with out of pocket costs above $150 for Epipens.
I do understand that people are concerned about the different usage instructions (for example the school nurse not realizing it needs to be used differently) and that doctors may be hesitant to prescribe it.
The thing I think is really interesting about the $150 generic Adrenaclick is that it puts some sort of ceiling on the regulatory costs and costs imposed by the other players in the health system.
The Mylan CEO did an interview this morning where they hand waved and equivocated and so on, but it's clear enough (based on availability of a $150 substitute) that they are setting the price based on their advantageous position in the market. I don't see any reason not to call them out on any BS where they try to deny that.
I do understand that people are concerned about the different usage instructions (for example the school nurse not realizing it needs to be used differently) and that doctors may be hesitant to prescribe it.
The thing I think is really interesting about the $150 generic Adrenaclick is that it puts some sort of ceiling on the regulatory costs and costs imposed by the other players in the health system.
The Mylan CEO did an interview this morning where they hand waved and equivocated and so on, but it's clear enough (based on availability of a $150 substitute) that they are setting the price based on their advantageous position in the market. I don't see any reason not to call them out on any BS where they try to deny that.
But they don't offer it in a dosage appropriate for young kids (0.15mg) like Epipen Jr.
On the page I link, I'm able to click the dropdown menu by the dosage and select 0.15 mg.
If your kid is allergic and needs an EpiPen (or something like it), most school districts will not allow the child to attend class unless they have one at the school. Maybe two.
And of course you have to carry them. There's another two.
So that's $2400. Out of pocket if you don't have insurance, or if your insurance doesn't pay.
The EpiPen manufacturers are abusing their monopoly.
And of course you have to carry them. There's another two.
So that's $2400. Out of pocket if you don't have insurance, or if your insurance doesn't pay.
The EpiPen manufacturers are abusing their monopoly.
Given the proper age, teaching kids to use syringe/vials or having a school nurse that can administer epinephrine would be a much cheaper alternative.
EpiPens are purely about the delivery mechanism. Stabbing a syringe into your thigh and injecting a predetermined amount of epinephrine into your leg isn't majorly complicated.
Maybe having a single pen on the kid and vials/syringes at the school would be a cheaper option.
EpiPens are purely about the delivery mechanism. Stabbing a syringe into your thigh and injecting a predetermined amount of epinephrine into your leg isn't majorly complicated.
Maybe having a single pen on the kid and vials/syringes at the school would be a cheaper option.
I don't think you've ever seen a child in Anaphylactic Shock if you think all you need to do is train the child to use a vial and needle. Even training school personnel is not a great idea - While an ER nurse or paramedic can handle it because they give injections every day, a teacher or even a school nurse may go for years without ever needing to do an epinephrine injection and the stress and inexperience may make them unable to perform under pressure of having a child dying in front of them.
An IM injection is easy to do when you're calm, but just filling the syringe can be difficult when you're under intense pressure.
An IM injection is easy to do when you're calm, but just filling the syringe can be difficult when you're under intense pressure.
I wonder why glucagon isn't done in the same format as EpiPens are. I'm a T1 diabetic and I have one glucagon vial at work and one at home. In the case I go low (barely responsive low) someone has to go grab it from the fridge (it needs to be there) load the syringe and use it on me.
When people sleep over I teach them how to use it and I do something like a show and tell at job from time to time so new people know about it.
When people sleep over I teach them how to use it and I do something like a show and tell at job from time to time so new people know about it.
It's not just 'load' the syringe. There's a liquid and a powder that has to be mixed. First, the liquid is injected into the powder. Remember to remove the protective cap from the vial and the two protective caps from the needle (apparently, people frequently forget the one on the vial and break the syringe). Then, mix by rolling, not shaking, for 30 seconds. Then, withdraw the mixture into the syringe and inject it.
Not only does it need to be kept refrigerated, the shelf-life isn't that long to begin with (about a year).
I'm also a T1D and there's a reason that, despite the various seizures I've had in my lifetime, I've never received Glucagon.
Cake icing squirted between your gum and cheek also works (although everything ends up sticky and blue by the end of it).
Edit: I didn't mean to sound like you didn't know what you were talking about, I just wanted to expand on what you were saying about 'show and tell'
Not only does it need to be kept refrigerated, the shelf-life isn't that long to begin with (about a year).
I'm also a T1D and there's a reason that, despite the various seizures I've had in my lifetime, I've never received Glucagon.
Cake icing squirted between your gum and cheek also works (although everything ends up sticky and blue by the end of it).
Edit: I didn't mean to sound like you didn't know what you were talking about, I just wanted to expand on what you were saying about 'show and tell'
Is there a reason the syringes can't be pre-filled so that the step of filling from the vial needn't be done under pressure?
I've never used an auto-injector on myself before. I have used expired auto-injectors on oranges and potatoes to make sure that I have a "real feel" for how the hypodermic needle really injects. The trainer injectors certainly don't teach you what that is like!
Having said that, I would vastly prefer an auto-injector compared to a syringe + vial. I'm not sure if I would have the proper composure/state of mine, let alone the visual acuity (eyelids swell up real bad during anaphylactic shock) needed to operate a syringe and vial during an episode of anaphylactic shock.
In more controlled situations like at a school nurse's office, where the patient isn't the administering the epinephrine to themselves, I can see the syringe and vial solution to be appropriate.
Having said that, I would vastly prefer an auto-injector compared to a syringe + vial. I'm not sure if I would have the proper composure/state of mine, let alone the visual acuity (eyelids swell up real bad during anaphylactic shock) needed to operate a syringe and vial during an episode of anaphylactic shock.
In more controlled situations like at a school nurse's office, where the patient isn't the administering the epinephrine to themselves, I can see the syringe and vial solution to be appropriate.
Don't forget that they expire as well - I have two kids that require the pens and even with insurance it works out to quite a cost.
And that pharmacies will often try to give you EpiPens with an expiration date less than a year away, indirectly increasing the cost (since most districts will require unexpired pens, and refuse your child even if then pen is a day too old).
It's a racket.
It's a racket.
The adrenaclick generic is much cheaper than the epipen, with or without insurance. Although technically different epinephrine auto injectors cannot be substituted (you can only be prescribed the one written by your doctor, or its generic equivalent), practically speaking the only difference between the epipen and the adrenaclick design is the instructions for use. I would hope there isn't a case of doctors being unaware of the alternatives.
My doctor/pharmacy was apparently unaware of the differences or neglected to inform me. At some point in the last 4 years I started getting generic Adrenaclicks instead of EpiPens. The difference between EpiPens and generic Andrenaclicks was never presented to me as a different choice in medications, just an "expensive brand name" vs "cheap generic" choice. I wonder who screwed that one up.
I did notice the different usage directions (mainly two safety caps with the generic vs one for the EpiPen) but never thought that the FDA considered them to not be equivalents. At least I made sure to carefully read the administration instructions and have trained with dummy, training auto-injectors and expired, real auto-injectors!
I did notice the different usage directions (mainly two safety caps with the generic vs one for the EpiPen) but never thought that the FDA considered them to not be equivalents. At least I made sure to carefully read the administration instructions and have trained with dummy, training auto-injectors and expired, real auto-injectors!
It's your doctor's fault if you didn't get the substitute earlier. As adrenaclick and epipen are not actually equivalent (even though ultimately they deliver the same medicine, in the same dose, in the same manner), the pharmacist is not supposed to do anything but provide what was prescribed.
Thank you for mentioning adrenaclick. Generics have been completely missing from the public debate. While epipen price gouging is very real, and a problem, there is one short term solution for allergy sufferers: demand an Rx for the generic. They are under $200 (source: checkyourmeds.com). Vote with your wallet!!
Looks like the differences are: extra safety cap and Epipen brand has an auto-retracting needle.
https://m.youtube.com/watch?v=LRgqwgCh4Fs
Looks like the differences are: extra safety cap and Epipen brand has an auto-retracting needle.
https://m.youtube.com/watch?v=LRgqwgCh4Fs
Great business to be in, attach an auto injection mechanism to maybe $5 worth of syringe and epinephrine.
Then undercut your competition by over 60%. I hope they do well. If more generic manufacturers get in on this or the patent expires we might see this go down to a more reasonable <$50 price, but this is definitely a step in the right direction.
Then undercut your competition by over 60%. I hope they do well. If more generic manufacturers get in on this or the patent expires we might see this go down to a more reasonable <$50 price, but this is definitely a step in the right direction.
Unfortunately there is no generic for Epipen. Unless you have been written a prescription for Adrenaclick specifically, you can't get it, or the generic version.
I don't understand why a prepackaged vial/syringe kit isn't readily available for epinephrine. It works just fine for glucagon...
http://www.childrenwithdiabetes.com/d_0n_022.htm
We're literally talking about $1 worth of epinephrine, a $0.50 syringe, and a couple cents worth of injection molded plastic case...
http://www.childrenwithdiabetes.com/d_0n_022.htm
We're literally talking about $1 worth of epinephrine, a $0.50 syringe, and a couple cents worth of injection molded plastic case...
Probably because that is not what matters. With the epipen, I can just jam it into my daughters thigh, straight through thick winter clothing and all. I don't need to ensure she gets the dosage right, nor that the syringe doesn't break.
My point is that with a very slight increase in the complexity of the process, you could have a _dramatic_ reduction in cost.
New York State is actually in the process of transitioning EMTs from EpiPens to vial/syringe kits.
New York State is actually in the process of transitioning EMTs from EpiPens to vial/syringe kits.
EMTs are not the target customer of epipens. They work with life-threatening situations day after day. To a kindergarten teacher, if a child if having an anaphylactic chock, this is very far from a "very slight increase in complexity".
Just to ground the situation, the kindergarten teachers at my daughters place are already freaked out from the thought of having to administer an epipen. I can't even start to imagine how they would handle a syringe and a bottle.
Just to ground the situation, the kindergarten teachers at my daughters place are already freaked out from the thought of having to administer an epipen. I can't even start to imagine how they would handle a syringe and a bottle.
There are thousands of people out there who carry IM Glucagon kits, an similarly time sensitive medication, intended to be administered by untrained bystanders. If it works for Glucagon, I see no reason it can't work for Epinephrine. In reality, there's no need for a vial, the syringe can be prefilled with the correct dose.
[deleted]
How many people will this price hike kill? I'm sure that's estimable.
What would be morally justified, to stop it?
What would be morally justified, to stop it?
Nah because it would upset the free market.
I mentioned in another comment when someone from Europe or Canada asked something to the effect of "how come everything has to be free market in US even healthcare and such".
And I think the answer is we treat free market as a religion. We don't evaluate what is better, healthier, more rational answer for a problem. Like say, "How do we keep people from dying from anaphylaxis?" We don't answer that. We always answer first, what would free market want? Will it want us to do this? If not, we don't proceed.
We treat it as if it is deity of sorts and if we disobey we'll be punished.
Someone replied and said this idea isn't so outrageous because a similar concept has been defined already in politics:
American Civil Religion (https://en.wikipedia.org/wiki/American_civil_religion)
I am just proposing there is a similar religion in respect to free market.
It is often sold in propaganda terms of course -- we are not communists here, we just want efficiency, we want progress, don't worry stuff will trickle down eventually and so on. So we make it palatable but the main incentive is worshiping the deity.
It sounds crazy but evaluating a lot of things we do as a society through that perspective can be interesting.
I mentioned in another comment when someone from Europe or Canada asked something to the effect of "how come everything has to be free market in US even healthcare and such".
And I think the answer is we treat free market as a religion. We don't evaluate what is better, healthier, more rational answer for a problem. Like say, "How do we keep people from dying from anaphylaxis?" We don't answer that. We always answer first, what would free market want? Will it want us to do this? If not, we don't proceed.
We treat it as if it is deity of sorts and if we disobey we'll be punished.
Someone replied and said this idea isn't so outrageous because a similar concept has been defined already in politics:
American Civil Religion (https://en.wikipedia.org/wiki/American_civil_religion)
I am just proposing there is a similar religion in respect to free market.
It is often sold in propaganda terms of course -- we are not communists here, we just want efficiency, we want progress, don't worry stuff will trickle down eventually and so on. So we make it palatable but the main incentive is worshiping the deity.
It sounds crazy but evaluating a lot of things we do as a society through that perspective can be interesting.
That's silly. How do you propose to "evaluate what is better, healthier, more rational"? I suppose some panel of experts could give you their best approximation, but it will always be sub-optimal. Markets exist in order to answer these questions, and they answer them by delegating the decision to every person involved in the decision, not by hoping a designated person can make a guess that's close enough.
It appears that the problem in this case is that there is a single producer who is able to engage in monopolistic pricing, which is certainly not something a market-oriented person would condone.
And the market for healthcare is not a free market. Not anything resembling a free market.
It appears that the problem in this case is that there is a single producer who is able to engage in monopolistic pricing, which is certainly not something a market-oriented person would condone.
And the market for healthcare is not a free market. Not anything resembling a free market.
> Markets exist in order to answer these questions,
Well in this case it answered that the price should be $600. This means people, kids, astamatics are going to die at some point in higher numbers because of that.
I say the market is drunk or evil and should not be allowed to make medical decisions.
But because it has a religious following, we don't want to make it angry so we can't say "we mandate EpiPen cost to be $25". Instead we dance around it and say "oh we'll create this health insurance thing, and then that will pay for it". But only if you work. Or ... if you don't you have to buy it anyway, or you have to pay a penalty. But unless you are old, then we kind a let you off the hook a bit and you sign up for this other thing. All of that is done in paper and in how it is presented to the public because we don't want to upset the free market gods.
Well in this case it answered that the price should be $600. This means people, kids, astamatics are going to die at some point in higher numbers because of that.
I say the market is drunk or evil and should not be allowed to make medical decisions.
But because it has a religious following, we don't want to make it angry so we can't say "we mandate EpiPen cost to be $25". Instead we dance around it and say "oh we'll create this health insurance thing, and then that will pay for it". But only if you work. Or ... if you don't you have to buy it anyway, or you have to pay a penalty. But unless you are old, then we kind a let you off the hook a bit and you sign up for this other thing. All of that is done in paper and in how it is presented to the public because we don't want to upset the free market gods.
Setting prices via administrative fiat doesn't eliminate problems. If the price is set to low, there will be shortages or no product at all. If the price is set to high, then the blame for the high price is shifted to the legislature rather than the supplier.
In any case, it is the government that is creating the conditions that allow the price to be set so high in this case. Blaming the 'market' for adjusting to the conditions created by government is confusing cause and effect.
In any case, it is the government that is creating the conditions that allow the price to be set so high in this case. Blaming the 'market' for adjusting to the conditions created by government is confusing cause and effect.
Enough rhetoric.
"Ah, but what do you propose, eh, Mr. Expert?"
-"Oh, maybe this?"
"AHA! This flaw would prevent that from being a workable solution. Keep the status quo!"
As if (a) understanding that there is a problem necessarily means that one must understand the solution, or (b) as if we live in a vacuum and this hasn't been addressed by dozens of other nations.
It has been addressed. In a dozen different ways, with different pros and cons. I can't tell you if the British or German or Japanese method is better, but I can tell you that we're the only schmucks going bankrupt to avoid death by bee-sting.
"Ah, but what do you propose, eh, Mr. Expert?"
-"Oh, maybe this?"
"AHA! This flaw would prevent that from being a workable solution. Keep the status quo!"
As if (a) understanding that there is a problem necessarily means that one must understand the solution, or (b) as if we live in a vacuum and this hasn't been addressed by dozens of other nations.
It has been addressed. In a dozen different ways, with different pros and cons. I can't tell you if the British or German or Japanese method is better, but I can tell you that we're the only schmucks going bankrupt to avoid death by bee-sting.
NICE does a pretty good job in the UK.
https://www.nice.org.uk/
https://www.nice.org.uk/
I'm pretty sure you could put together epinephrine and a syringe for a few bucks. And sell it for twenty or so with a healthy profit.
But you can't, can you? Is that because of free market worship, or worship of the regulatory state?
But you can't, can you? Is that because of free market worship, or worship of the regulatory state?
> But you can't, can you?
Yes you can! Believe it or not this completely unregulated free market utopia exists. It is not just a fantasy. Now don't get excited, I imagine after I tell you about you it, you probably won't be headed to the airport to go there -- that's because it is actually horrible.
Unregulated market is what was (and is) happening in any of the post-Soviet republics, Russia, probably China, probably many other countries.
Those countries are better at free market than America. Yes on paper they have their EPAs, FCCs, FDA and other nuisances, but in practice nobody cares.
So you can buy some pills from the street corner shop that sells cigarettes. But chances are they are expired at best, made in a basement from chalk and sugar, or harmful at worst. Of course the claim is, "ah but market takes care of it, next time you won't buy from there and they'll go out of business". Nope, you might be dead next time and no they won't go out of business.
You can go and buy unregulated vegetables from the market. And they look fresh and plump and nice, but they are chock full of horrible chemicals in them. How do I know? My relatives there grow and sell them. They have a separate plot of land for such things and wouldn't let their kids or themselves eat from there.
Gun ownership there is restricted. Unless you are friends with the police. Then you can have a special permit for a gun. Oh but you have to pass a psych exam to make sure you are not crazy. But it so happens you are crazy. But, no worries, such regulations are bypassed with a quick $50 gift. And yes, I have seen them shoot their Dragunov sniper rifle, in a village, with houses right next to each other, and nobody cares.
The list goes on. Now maybe I assumed too much that you won't like it. Who knows, maybe you would. Well you are welcome to visit and try it out.
Yes you can! Believe it or not this completely unregulated free market utopia exists. It is not just a fantasy. Now don't get excited, I imagine after I tell you about you it, you probably won't be headed to the airport to go there -- that's because it is actually horrible.
Unregulated market is what was (and is) happening in any of the post-Soviet republics, Russia, probably China, probably many other countries.
Those countries are better at free market than America. Yes on paper they have their EPAs, FCCs, FDA and other nuisances, but in practice nobody cares.
So you can buy some pills from the street corner shop that sells cigarettes. But chances are they are expired at best, made in a basement from chalk and sugar, or harmful at worst. Of course the claim is, "ah but market takes care of it, next time you won't buy from there and they'll go out of business". Nope, you might be dead next time and no they won't go out of business.
You can go and buy unregulated vegetables from the market. And they look fresh and plump and nice, but they are chock full of horrible chemicals in them. How do I know? My relatives there grow and sell them. They have a separate plot of land for such things and wouldn't let their kids or themselves eat from there.
Gun ownership there is restricted. Unless you are friends with the police. Then you can have a special permit for a gun. Oh but you have to pass a psych exam to make sure you are not crazy. But it so happens you are crazy. But, no worries, such regulations are bypassed with a quick $50 gift. And yes, I have seen them shoot their Dragunov sniper rifle, in a village, with houses right next to each other, and nobody cares.
The list goes on. Now maybe I assumed too much that you won't like it. Who knows, maybe you would. Well you are welcome to visit and try it out.
I'm sure there are some people that truly want the unfettered, caveat emptor world that you describe, but I think that is a mischaracterization of what most free-market advocates are actually talking about.
The type of regulations/laws are hugely important. Critical statements regarding existing regulations are not the same thing as advocating for no regulations whatsoever.
I think it is more useful to view calls for a 'free market' to really be calls for a 'minimally regulated market'. For example, regulations and laws that penalize fraud and negligence are well within the scope of a 'minimally regulated market'.
The type of regulations/laws are hugely important. Critical statements regarding existing regulations are not the same thing as advocating for no regulations whatsoever.
I think it is more useful to view calls for a 'free market' to really be calls for a 'minimally regulated market'. For example, regulations and laws that penalize fraud and negligence are well within the scope of a 'minimally regulated market'.
> But you can't, can you?
Why not? It works for glucagon (which is even more complicated, since it has to be reconstituted from a powder).
http://www.childrenwithdiabetes.com/gifs/products/GlucaGenA1...
Why not? It works for glucagon (which is even more complicated, since it has to be reconstituted from a powder).
http://www.childrenwithdiabetes.com/gifs/products/GlucaGenA1...
How is government protecting a monopoly free market exactly?
Why is it protecting a monopoly? Why doesn't it say "this EpiPen can't cost more than $30"?
Perhaps because it actually costs more than $30 and so an edict such of this would guarantee that there are no EpiPens at all?
In any case, the current high price is the result of regulatory/legislative actions and so the current price is evidence of regulatory failure, not market failure.
In any case, the current high price is the result of regulatory/legislative actions and so the current price is evidence of regulatory failure, not market failure.
I don't think it is a massive regulatory failure to have the pharmacy dispense a product with matching use instructions to the product that is prescribed.
So it's the market that has doctors prescribing $600 Epipens instead of the $150 alternative (that has different use instructions and thus cannot be used to fill a prescription for an Epipen).
So it's the market that has doctors prescribing $600 Epipens instead of the $150 alternative (that has different use instructions and thus cannot be used to fill a prescription for an Epipen).
Isn't this just another example of a problem created by the rules/regulations? A pharmacist is forbidden from providing the $150 alternative even if the customer specifically requests it (because of the prescription requirement and rules).
For those who need epinephrine injectors, can't they just ask their doctors to prescribe Adrenaclick? What prevents that from happening? I'm guessing it is insurance guidelines that are also stuck in the EpiPen-only world but perhaps it is also doctors being too conservative?
For those who need epinephrine injectors, can't they just ask their doctors to prescribe Adrenaclick? What prevents that from happening? I'm guessing it is insurance guidelines that are also stuck in the EpiPen-only world but perhaps it is also doctors being too conservative?
It's marketing. I saw some discussion on social media, people expressed a preference for the Epipen because they expected other people to be more aware of how to use it.
Same with parents, they expect the school nurse to be more familiar with the Epipen (and I guess the other way around, the nurses prefer Epipen because they are familiar with it).
If asking the pharmacist for a specific type of injector isn't onerous then neither is asking the doctor.
I'm willing to concede that US medical regulation has lots of problems, but there is also clearly some problems with the way people in this market are behaving. Patients should care about saving $1000-$1500. Doctors should care about saving their patients $1000-1500.
Same with parents, they expect the school nurse to be more familiar with the Epipen (and I guess the other way around, the nurses prefer Epipen because they are familiar with it).
If asking the pharmacist for a specific type of injector isn't onerous then neither is asking the doctor.
I'm willing to concede that US medical regulation has lots of problems, but there is also clearly some problems with the way people in this market are behaving. Patients should care about saving $1000-$1500. Doctors should care about saving their patients $1000-1500.
Well in a perverse sort of way, the $600 price tag is certainly one way to motivate patients to demand alternatives from their doctors and insurance companies.
Because then no one will manufacture it. You can't just will things into existence with unrealistic feel good rhetoric.
If the cost is $5 why wouldn't someone manufacture it then?
> You can't just will things into existence with unrealistic feel good rhetoric.
Why not? We've willed wars and consequent huge handouts to the military industrial complex. I am sure if we tried a bit we can will into existance some $30 EpiPens.
> You can't just will things into existence with unrealistic feel good rhetoric.
Why not? We've willed wars and consequent huge handouts to the military industrial complex. I am sure if we tried a bit we can will into existance some $30 EpiPens.
You might be able to coerce (by force) the world to give you what you want at the price that you want. But that doesnt mean it comes without a price. There is always a cost and many times, with governmental interference much of it is unintended consequences not immediately seen.
If the pen cost less than $30 to manufacture, there's no reason that no one would manufacture it.
That's what they did in Venezuela for a whole host of products you can no longer find.
EXACTLY
A free market would mean anyone who wanted to to create one of these.
A free market would mean anyone who wanted to to create one of these.
The reason that EpiPens are expensive is because they're patent protected. In this case, regulatory protection that is the explicit issue. Demand for the product is clearly there; supply is not, not because there is nobody willing to provide it, but because the government prevents would-be competitors from doing so.
Why do you and many other characterize this as a free market failure? If anything this is a regulatory failure.
It's interesting how Americans act horrified at the word collectivism, when a market is nothing if not a collectivist decision making process.
I dunno. I bet it's a pretty small number. Fewer than 100 people die per year in the US from anaphylaxis and it's hard to find evidence that this number has risen along with the price of the EpiPen.
At the top end maybe the answer to your question is a dozen or so. About the same order of magnitude as the number of people that die due to dog bites.
It's really small.
At the top end maybe the answer to your question is a dozen or so. About the same order of magnitude as the number of people that die due to dog bites.
It's really small.
Fair enough. Maybe it's not such a big deal then.
How many people would die if the only manufacturer of the device goes out of business?
It's not a flippant question; their only competitor pulled their product off the market, because the cost of fixing bugs was too great. How would it have helped to force them to charge less?
http://www.fiercepharma.com/marketing/sanofi-s-auvi-q-recall...
It's not a flippant question; their only competitor pulled their product off the market, because the cost of fixing bugs was too great. How would it have helped to force them to charge less?
http://www.fiercepharma.com/marketing/sanofi-s-auvi-q-recall...
There are from 30-950 cases per 100,000 people per year.
Or an 0.03% to 0.9% incidence rate. That sets an upper bound on deaths. It corresponds to about 100,000 to 3 million exposures per year. If 10% of those were potentially fatal without treatment, you'd be looking at 10,000 to 300,000 deaths/year. Keep in mind I just pulled 10% out of my ass.
You'd want to see how many people or cases would be untreated at the higher price level. But the information certainly supports the notion of thousands of deaths.
At 1,000 deaths, that's about 1.6 million in profits per corpse for Mylan, based on $1.6 billion in additional profit.
http://rnspeak.com/case-study/anaphylactic-shock-case-study-...
Or an 0.03% to 0.9% incidence rate. That sets an upper bound on deaths. It corresponds to about 100,000 to 3 million exposures per year. If 10% of those were potentially fatal without treatment, you'd be looking at 10,000 to 300,000 deaths/year. Keep in mind I just pulled 10% out of my ass.
You'd want to see how many people or cases would be untreated at the higher price level. But the information certainly supports the notion of thousands of deaths.
At 1,000 deaths, that's about 1.6 million in profits per corpse for Mylan, based on $1.6 billion in additional profit.
http://rnspeak.com/case-study/anaphylactic-shock-case-study-...
If people don't want to buy two epipen there's always that neat trick for multiple doses in precarious locations far from hospitals.
It is a well known hack taught in wilderness medicine training.
https://www.youtube.com/watch?v=luultUD0eK0
It is a well known hack taught in wilderness medicine training.
https://www.youtube.com/watch?v=luultUD0eK0
So a "used" epi-pen's internal syringe might contain 4-5x more epinephrine than actually goes into a standard dose? I assume this means most of the expense of making it comes from the housing/mechanics. (And recouping whatever cost of QA/approvals.)
I haven't worked with this class of medical device, but I expect the major cost of the unit is in the approvals and lawsuits.
So far as the pen itself - They've got some injection-molded plastic, where the mold costs are amortized across the production lifetime. A needle + syringe, which are probably subcontracted from Becton Dickinson. A spring. A printed label. And the medication itself (probably the #2 cost).
The assembly of the above all had to conform to the FDA's Good Manufacturing Practices rules. Every part & ingredient had to have trace-ability to their source. With documentation thereof.
When we got our device approved (in a looser classification than this) we had to get UL approval ($50k per test, per device, per test-run), and we had 3 people on staff whose sole purpose was navigating the FDA paperwork and their approval process. I never heard what that cost was, but it was substantial. And then we had an IP attorney, and corporate defense attorneys to respond to the inevitable lawsuits.
So far as the pen itself - They've got some injection-molded plastic, where the mold costs are amortized across the production lifetime. A needle + syringe, which are probably subcontracted from Becton Dickinson. A spring. A printed label. And the medication itself (probably the #2 cost).
The assembly of the above all had to conform to the FDA's Good Manufacturing Practices rules. Every part & ingredient had to have trace-ability to their source. With documentation thereof.
When we got our device approved (in a looser classification than this) we had to get UL approval ($50k per test, per device, per test-run), and we had 3 people on staff whose sole purpose was navigating the FDA paperwork and their approval process. I never heard what that cost was, but it was substantial. And then we had an IP attorney, and corporate defense attorneys to respond to the inevitable lawsuits.
The drug itself is very cheap. With an Rx you can purchase an ampule with about 3 doses for < $10.[1] You can administer it with an insulin syringe, which I don't think requires an Rx. Of course administration is a lot more tedious and requires some training.
I worked at a summer camp where we would carry 1 or 2 pens plus a bunch of ampules if we were in a wilderness situation where we couldn't get to emergency care and needed more than one dose.
[1] http://www.buyemp.com/product/epinephrine-ampule
I worked at a summer camp where we would carry 1 or 2 pens plus a bunch of ampules if we were in a wilderness situation where we couldn't get to emergency care and needed more than one dose.
[1] http://www.buyemp.com/product/epinephrine-ampule
The drug is cheap...because it's unpatentable (as a molecule anyway) and is old enough that any patents would be expired anyway.
The marketing of autoinjectors has some legitimate public health value, but it's also a clear business strategy to get new drug prices for an ancient drug
The marketing of autoinjectors has some legitimate public health value, but it's also a clear business strategy to get new drug prices for an ancient drug
If you have something concrete to say then say it. You're only lowering the quality of the conversation by making vague assertions in the style of "one weird trick" followed by mystery links to random places on the web.
How is this lowering the quality of the conversation? This is an insightful comment with a relevant video that shows that each Epipen actually contains 4 or 5 doses of epinephrine. Certainly relevant, as we are discussing how people nationwide are struggling to obtain enough of this drug.
Also, I would hardly call a link to YouTube "a mystery link to a random place on the web".
Also, I would hardly call a link to YouTube "a mystery link to a random place on the web".
This "one weird trick" may save your life if you experience anaphylactic shock and do not have multiple auto-injectors available, for whatever reason (cost, some have expired, remote location, etc).
I discovered this technique a couple of years ago and was interested in it. I tried replicating the use with some expired autoinjectors. As far as delivering subsequent doses, I was able to reliably deliver 2+ more doses (into oranges) from my expired injectors. I feel better prepared for an emergency now.
I have never needed to use my autoinjector. I had one incident where I was very close to shooting up my thigh but the symptoms were just "mild" enough that I did not. I met another person with severe food allergies at THOTCON this year who described to me in detail two separate incidences where he felt it was necessary to administer two doses. I hadn't really given much thought to multiple doses before hearing his stories (one of which included a medically induced coma). Now I make sure to have at least two doses on hand. My doctor certainly didn't express to me the potentially dire necessity of multiple doses!
Of course, this bushcraft advice doesn't hamper my cautiousness about having autoinjectors around everywhere I may need them. I have a pair at my home, my office, my parents home, and my backpack (always with me when I travel). Eight autoinjectors, that need scheduled replacement, is a luxury I can afford. Others may not be so lucky and may be helped by these bushcraft techniques.
I do need to research the issue more though because my insurance currently covers eight autoinjectors (not EpiPen brand, but a "generic"? Lineage Therapeutics brand [0]) at the rate of $15 per two 0.3 mg injectors. I'm not sure if I'm lucky, have great insurance, or what.
[0]: http://www.epinephrineautoinject.com
I discovered this technique a couple of years ago and was interested in it. I tried replicating the use with some expired autoinjectors. As far as delivering subsequent doses, I was able to reliably deliver 2+ more doses (into oranges) from my expired injectors. I feel better prepared for an emergency now.
I have never needed to use my autoinjector. I had one incident where I was very close to shooting up my thigh but the symptoms were just "mild" enough that I did not. I met another person with severe food allergies at THOTCON this year who described to me in detail two separate incidences where he felt it was necessary to administer two doses. I hadn't really given much thought to multiple doses before hearing his stories (one of which included a medically induced coma). Now I make sure to have at least two doses on hand. My doctor certainly didn't express to me the potentially dire necessity of multiple doses!
Of course, this bushcraft advice doesn't hamper my cautiousness about having autoinjectors around everywhere I may need them. I have a pair at my home, my office, my parents home, and my backpack (always with me when I travel). Eight autoinjectors, that need scheduled replacement, is a luxury I can afford. Others may not be so lucky and may be helped by these bushcraft techniques.
I do need to research the issue more though because my insurance currently covers eight autoinjectors (not EpiPen brand, but a "generic"? Lineage Therapeutics brand [0]) at the rate of $15 per two 0.3 mg injectors. I'm not sure if I'm lucky, have great insurance, or what.
[0]: http://www.epinephrineautoinject.com
If the product is decades-old, why haven't generic variants appeared?
Something seems to be missing from this article.
Something seems to be missing from this article.
There are generics. What is patented is the delivery mechanism. I've had to administer it twice. You take the cap off and just push it into the thigh. The top part moves back and the needle pushes through.
Thanks, so this is the missing information. The article misleadingly says the medication is decades-old, where actually the pen itself is patented.
The patent is expired: https://www.google.com/patents/US4031893
Courtesy ceejayoz below: https://news.ycombinator.com/item?id=12340464
Courtesy ceejayoz below: https://news.ycombinator.com/item?id=12340464
so why aren't there more case manufactures
For the same reason there were no competitors to daraprim before Martin Shkreli decided to be a complete ja. When the price is low enough that there's little profit to be had, nobody bothers competing because it's not worth the time, money, and effort to get FDA approval. When the price gets jacked up like that, you will find generics pop up quickly. The problem is the window between the price hike and when generics pop up can sometimes be years due to needing to get FDA approval.
In this case there was a competitor, but they recently had their product pulled from the market in an FDA recall. So Mylan decided: why not raise the price 600% (and rising) when it's a drug people HAVE to have.
Capitalism in action baby. Let's deregulate EVERYTHING!
In this case there was a competitor, but they recently had their product pulled from the market in an FDA recall. So Mylan decided: why not raise the price 600% (and rising) when it's a drug people HAVE to have.
Capitalism in action baby. Let's deregulate EVERYTHING!
If EVERYTHING were deregulated, the time, money, and effort to get FDA approval would also vanish along with this particular problem. Would other worse problems appear in its place? Maybe. But calling foul on free-market capitalism in the very most regulated market in the US is a bit disingenuous.
Hmmm... from your description, it sounds like the market is working, just not fast enough for everyone.
It's not worth it for a company to develop their own Epi-pen since profits are so low. Eventually enough drop out that one manufacturer raises the price. Significant profits result which attracts other competitors. Prices drop.
Would you just prefer the gov't to step in and set the price? What happens if companies decide it's not worth the effort? Have the gov't force them to produce the product?
It's not worth it for a company to develop their own Epi-pen since profits are so low. Eventually enough drop out that one manufacturer raises the price. Significant profits result which attracts other competitors. Prices drop.
Would you just prefer the gov't to step in and set the price? What happens if companies decide it's not worth the effort? Have the gov't force them to produce the product?
> Would you just prefer the gov't to step in and set the price? What happens if companies decide it's not worth the effort? Have the gov't force them to produce the product?
Cut out the private market and have the government manufacture it directly.
Cut out the private market and have the government manufacture it directly.
Can you give me some examples where the gov't has come in as a manufacturer and it's actually gone well?
They've done pretty well in the power sector. One could argue that most power (electric) companies are really just state run shells.
https://en.wikipedia.org/wiki/Hoover_Dam
https://en.wikipedia.org/wiki/Hoover_Dam
I don't know of any case in which the US government has attempted to fulfill the role of manufacturer; that does not mean we should not try.
Because there's no equivalent of the bioequivalence study that generic drugs go through. Even if it's an exact copy, making a generic medical device means you have to go through the same entire approval process that the original went through.
Other posts have pointed out that companies have tried and failed to produce generics. Seems like a really broken patent system if the patent isn't descriptive enough to allow competitors to actually produce the product. Isn't the point of filing the patent to allow things to progress once the inventor has had their monopoly?
its to build upon it too
it is primarily to avoid redundancies
it is primarily to avoid redundancies
I'm pretty sure this isn't true. There are plenty of self-injector designs and many of them are off patent.
The real reason is that other companies have screwed up getting their devices approved. Other versions of Epi-pen were on the market and they were pulled since they didn't work.
The real reason is that other companies have screwed up getting their devices approved. Other versions of Epi-pen were on the market and they were pulled since they didn't work.
Mylan refers the press to their local politicians "go talk to them about it, we pay our lobbying fees to get whoever we want elected specifically so we can charge any price we want, you can't do a damn thing - it's a free country".
[deleted]
Why haven't competitors entered the market with cheaper products?
They did. Windgap[1] took venture capital, took state funding from Massachusetts back in 2012, and didn't ship the product. Cool web site, though. Sanofi tried, but their product misfired at least 26 times and was recalled.[2] Teva tried, and their product was rejected by the FDA because of problems; they're going to try again with a new model in 2017.[3]
[1] http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
[1] http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
Adrenaclick is still on the market. It's a different mechanism, but still an auto-injector.
http://www.adrenaclick.com/how_to_use_adrenaclick_epinephrin...
Some people apparently decide to buy vials of epinephrine and manually fill a syringe.
http://www.consumerreports.org/drugs/can-you-get-a-cheaper-e...
http://www.adrenaclick.com/how_to_use_adrenaclick_epinephrin...
Some people apparently decide to buy vials of epinephrine and manually fill a syringe.
http://www.consumerreports.org/drugs/can-you-get-a-cheaper-e...
Three companies tried and failed?
It sounds like it's harder than we might think to make this work.
Given that, and the low volumes, it might not be that profitable even at $600 per sale.
It sounds like it's harder than we might think to make this work.
Given that, and the low volumes, it might not be that profitable even at $600 per sale.
The companies that tried to enter the business were drug companies, not device companies. No expertise in volume manufacturing of medical-grade injection-molded plastic devices. There are companies which can do that.[1] There are automatic inspection technologies which can detect even minor flaws.[2] But the typical injection molding vendor isn't that good.
Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding.
[1] http://www.advancedmt.com/wp-content/uploads/2012/10/amt_med... [2] http://www.vision-systems.com/articles/print/volume-9/issue-...
Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding.
[1] http://www.advancedmt.com/wp-content/uploads/2012/10/amt_med... [2] http://www.vision-systems.com/articles/print/volume-9/issue-...
Both Teva and Sanofi have other drugs using auto-injectors in the market.
Weird! It doesn't seem like a particularly complicated device. Is anything publicly known about what was going wrong?
There are really two villains here, Mylan, of course, but more importantly, the FDA. FDA regulations make the cost of bringing a new medical device to the market absurd. There are no competitors because the time and effort to bring a competing device is so ridiculously high that it doesn't pay to do so.
I have a child with a peanut allergy. I am worried every damn day of my life. I see articles about people who die every year because they didn't have an Epipen handy. The numbers of people who die will increase. I want to see FDA bureaucrats hauled to those funerals so they can see what they've done.
I have a child with a peanut allergy. I am worried every damn day of my life. I see articles about people who die every year because they didn't have an Epipen handy. The numbers of people who die will increase. I want to see FDA bureaucrats hauled to those funerals so they can see what they've done.
So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really?
I also find your comment pretty uninformed considering that the FDA just paved the way for generic drug makers to basically "knock-off" super expensive biologic drugs like Humira and Enbrel which were previously covered by similar patents.
The FDA has it's problems - but to say that it is an agency staffed by people who don't care ("bureaucrats") who typically have both Ph.D and M.D.s and have dedicated their careers to ensure patients have safe and effective medicine is unfair.
edit: grammar.
I also find your comment pretty uninformed considering that the FDA just paved the way for generic drug makers to basically "knock-off" super expensive biologic drugs like Humira and Enbrel which were previously covered by similar patents.
The FDA has it's problems - but to say that it is an agency staffed by people who don't care ("bureaucrats") who typically have both Ph.D and M.D.s and have dedicated their careers to ensure patients have safe and effective medicine is unfair.
edit: grammar.
There's a big difference between "rigorous" and "prohibitively expensive."
> So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really?
Yes, if the process is so rigorous and expensive that it drives the cost of drugs beyond the reach of people who need them, and it hampers the effective functioning of the free market. And I think it's widely accepted that's far more expensive to bring a drug to market here than it is elsewhere in the world.
The FDA believes its mission should be to ensure that drugs are safe and effective. That is wrongheaded. Instead, it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit?
In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things.
I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either.
You want evidence this is an evil system? There it is.
Yes, if the process is so rigorous and expensive that it drives the cost of drugs beyond the reach of people who need them, and it hampers the effective functioning of the free market. And I think it's widely accepted that's far more expensive to bring a drug to market here than it is elsewhere in the world.
The FDA believes its mission should be to ensure that drugs are safe and effective. That is wrongheaded. Instead, it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit?
In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug. There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things.
I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either.
You want evidence this is an evil system? There it is.
> In the case of Epipens, there's little risk, because epinephrine is an old, widely-used drug.
Well one risk is that you'll jam the thing into your thigh and get no epinephrine, because the injection mechanism failed. If this happened to your son, and he died, would you take that outcome serenely? This is what the FDA is trying to prevent.
> There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life.
Then buy the bottle and syringe. The FDA is not, to my knowledge, preventing people from doing so. It's not as easy or reliable as an auto-injector, but it's also a lot cheaper, so it seems the system is already providing an alternative. There is also at least one other auto-injector on the market besides EpiPen. Again--not as easy to use, but cheaper.
Well one risk is that you'll jam the thing into your thigh and get no epinephrine, because the injection mechanism failed. If this happened to your son, and he died, would you take that outcome serenely? This is what the FDA is trying to prevent.
> There is some risk that it will be mis-administered by a less-than-perfect device, but the fact is that a $10 bottle of epinephrine and a $1 syringe can save a life.
Then buy the bottle and syringe. The FDA is not, to my knowledge, preventing people from doing so. It's not as easy or reliable as an auto-injector, but it's also a lot cheaper, so it seems the system is already providing an alternative. There is also at least one other auto-injector on the market besides EpiPen. Again--not as easy to use, but cheaper.
> it should undertake a rational risk/benefit approach. Rather than saying that no drug gets through the filter unless it's safe (as demonstrated through reams of evidence), it should ask, how much risk should we tolerate in exchange for how much benefit?
Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.
Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.
> The price of these drugs is directly linked with the risk*cost of being sued
Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.
Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.
I don't really think you know all the history here. There are other companies who have/are attempting to create competitors to EpiPen. A few of them weren't able to get passed by the FDA, and one of them passed the FDA in 2012 but was recalled because of the product misfiring. The EpiPen problem seems to be much less an FDA problem then it is a problem with manufacturing, other companies don't seem to be able to make products that work nearly as well as EpiPen. If the FDA wasn't in the picture, you would still have the problem that there aren't any other reliable replacements for EpiPen even though companies have tried.
IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ with a 100% success rate, or the one that's 100$ with a 95% success rate?". That sounds like a pretty bleak state of affairs, and could easily encourage cutting corners to cut costs. "How much does a death cost us?"
IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ with a 100% success rate, or the one that's 100$ with a 95% success rate?". That sounds like a pretty bleak state of affairs, and could easily encourage cutting corners to cut costs. "How much does a death cost us?"
What about buying 5 of them that are $20 bucks a piece? Maybe they can be made in a stackable format, so it would be easy to carry 5 of them. If one misfires, snap it off and use the next one in the stack.
That only works if you can actually tell if it misfired or not - if you're administering it to someone else, you may simply not be able to. With that, part of the problem was that the misfires would deliver some of the drug but not all, and only sometimes would completely fail to deliver any of the drug. Telling if you got 50% vs. 100% would probably be tough - and even if you could, if you took two because the first gave you 50%, you might end-up getting a big overdose or still get an underdose. So having multiple of those pens really just doesn't solve the problem if the pens themselves are unreliable.
> a $10 bottle of epinephrine and a $1 syringe can save a life
You're not prevented from using that method and some people and a lot of emergency services (that have relevant training) do. There are problems with that too though, epinephrine isn't completely stable and properly injecting when you or someone you know needs the shot isn't an easy task.
What the FDA is and should prevent are devices like the Auvi-Q that couldn't inject the proper amount reliably.
You're not prevented from using that method and some people and a lot of emergency services (that have relevant training) do. There are problems with that too though, epinephrine isn't completely stable and properly injecting when you or someone you know needs the shot isn't an easy task.
What the FDA is and should prevent are devices like the Auvi-Q that couldn't inject the proper amount reliably.
The workers ("staffed") in the FDA are (mostly, probably) people who want to help but the bureaucrats in charge are part of the political system (e.g. lobbyists, political insiders, etc.). I think you're conflating the workers of the FDA with the people who, ultimately, guide it and make decisions.
This isn't to say the leadership of the FDA is compromised by or somehow beholden to "Big Pharma" or some such. I certainly wouldn't disagree that we need rigorous demonstrations of efficacy and safety for medicines and devices, but I question in what manner and capacity the FDA is actually structured to pursue that end.
This isn't to say the leadership of the FDA is compromised by or somehow beholden to "Big Pharma" or some such. I certainly wouldn't disagree that we need rigorous demonstrations of efficacy and safety for medicines and devices, but I question in what manner and capacity the FDA is actually structured to pursue that end.
Approval and other decisions in the lifecycle of a drug (it's entire fate basically) are made by committees and panels of physicians primarily. The FDA does it's job well in my opinion and they use a panel system to make sure that no single pipeline / process ensnares a treatment:
http://www.fda.gov/AdvisoryCommittees/
It's a really difficult balance to strike with the FDA. Too strict and you get situations like this, too lenient and you get thalidomide. It's hard to come up with a single set of rules that will rush forward all good, effective medication, block all dangerous medication, and continue to do so despite constantly changing technology and understanding.
Clearly the epipen thing is a huge problem, and if the FDA can fix it, they need to do so ASAP or be ordered to do so by Congress. But I'm hesitant to say that their only motivation is petty bureaucracy.
Clearly the epipen thing is a huge problem, and if the FDA can fix it, they need to do so ASAP or be ordered to do so by Congress. But I'm hesitant to say that their only motivation is petty bureaucracy.
Exactly! I wouldn't want to be working at the FDA to be honest. On one hand you get blamed when an unsafe drug hits the market and the next day get blamed because you're holding up innovative.
They can't win!
They can't win!
I'm sure the FDA could be more efficient, but isn't a large part of the difficulty intrinsic to bringing a safe and effective device to the market? The flip side of people dying from not having an Epipen is people dying because their generic Epipen didn't work.
So allow devices to be labeled as "FDA approved" or "not evaluated by the FDA". Customers who value the FDA approved status can purchase those products. Customers who are comfortable determining the efficacy of a product via other means can purchase the non-evaluated products.
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.
If no one purchases the non-evaluated product then the market will have spoken and the non-evaluated products will disappear. On the other hand if the non-evaluated products are successful then the market will have provided a better product.
hmmh... what's the reg, specifically?
what I see is an unholy alliance between the regulators and industry to extract max profits.
if you don't have an approving authority for e.g. Epipens, it seems to be that you get something like the supplements industry which is mostly marketing and exploiting the ignorant. you need some IP protection for the crazy amount of incredibly skilled R&D and massive testing that goes into an Epipen but this is ridiculous.
drug and medical device companies merge for maximum market power vs. insurers, who try to merge for maximum market power against drug companies and doctors/hospitals.
eventually you'll have just one insurer and one drug company and one hospital company and you can nationalize the whole thing.
just kidding, but I see Obamacare failing if it can't evolve, prices continuing to go up, and eventually everyone demanding a single-payer solution.
what I see is an unholy alliance between the regulators and industry to extract max profits.
if you don't have an approving authority for e.g. Epipens, it seems to be that you get something like the supplements industry which is mostly marketing and exploiting the ignorant. you need some IP protection for the crazy amount of incredibly skilled R&D and massive testing that goes into an Epipen but this is ridiculous.
drug and medical device companies merge for maximum market power vs. insurers, who try to merge for maximum market power against drug companies and doctors/hospitals.
eventually you'll have just one insurer and one drug company and one hospital company and you can nationalize the whole thing.
just kidding, but I see Obamacare failing if it can't evolve, prices continuing to go up, and eventually everyone demanding a single-payer solution.
Obamacare is driving regional healthcare provider consolidation as well as insurer consolidation.
As drug innovation has slowed, single payer US healthcare will be the solution to these problems. Nationalize some/all of the provider networks and drugs like this become built to spec government bids where buying power drives cost down.
As drug innovation has slowed, single payer US healthcare will be the solution to these problems. Nationalize some/all of the provider networks and drugs like this become built to spec government bids where buying power drives cost down.
It isn't a free market. There are significant barriers to entry for medical products.
> Last year, the drug maker Sanofi recalled a competing product, Auvi-Q, because it may not have been delivering the correct amount of epinephrine, leaving the EpiPen as the primary emergency treatment for severe allergic reactions.
To all the folks in this thread suggesting 3D printing and all sorts of other ideas, keep in mind that Sanofi is not some fly-by-night or scrappy startup. They are a major pharmaceutical company with decades of experience manufacturing pharmaceuticals and the quality control that is required and even they couldn't get it right.
They actually had a very innovative product. It was much smaller than the EpiPen and used voice prompts to tell you how to administer the drug (people in the heat of the moment sometimes don't remember to leave the EpiPen in long enough for a proper dose to be fully administered). I'm frankly mystified how they botched things so badly that they had to pull the product.
They actually had a very innovative product. It was much smaller than the EpiPen and used voice prompts to tell you how to administer the drug (people in the heat of the moment sometimes don't remember to leave the EpiPen in long enough for a proper dose to be fully administered). I'm frankly mystified how they botched things so badly that they had to pull the product.
I have to wonder how well expertise in pharmaceutical manufacturing really translates into expertise in manufacturing an auto-injector. The hard part of the EpiPen is not the drug, it's the mechanics.
I'm confused about this myself. I used to receive EpiPen brand auto-injectors. At some point, I started receiving Lineage Therapeutics auto-injectors (supposedly an Adrenaclick generic) instead. According to [0] they are _not_ equivalent to EpiPens according to the FDA. I'm not sure if my primary care physician or my old pharmacist (CVS chain) are at fault for not informing me of the differences. My generic prescription costs me, with insurance, $15 for two 0.3 mg autoinjectors. Insurance has covered four twin auto-injector packs (8 individual auto-injectors total) without any hassle.
Either way, I have trained and informed myself on the proper use of the generic Adrenaclick auto-injector. From what I gather, the main differences are that there are two safety covers on both sides of the injector (instead of a cover on just the non-needle side) and the method of determining whether a dose was supposedly administered correctly (mainly, the EpiPen's needle cover is extended vs just observing an extended needle on the Adrenaclick). I am left to presume that their therapeutic effectiveness is the same, even though the FDA may not explicitly declare it as so. I will consult my physician and current pharmacist (local, non-chain pharmacy with excellent focus on patient care) to determine if I have any misunderstandings.
I have also trained the people most likely to administer epinephrine to myself (family, friends, coworkers) the particular procedures of Adrenaclick administration, so I am not too worried about procedural differences between EpiPens and my generic auto-injector.
Still, I am left wondering what the therapeutic difference between an EpiPen and a generic Adrenaclick alternative really is. I do understand that different administration procedures are a problem for training, but I would expect the actual therapeutic effects of both auto-injectors to be similar --- if used administered according to directions.
[0]: http://www.pharmacytimes.com/p2p/p2pepinephrine-0910
Either way, I have trained and informed myself on the proper use of the generic Adrenaclick auto-injector. From what I gather, the main differences are that there are two safety covers on both sides of the injector (instead of a cover on just the non-needle side) and the method of determining whether a dose was supposedly administered correctly (mainly, the EpiPen's needle cover is extended vs just observing an extended needle on the Adrenaclick). I am left to presume that their therapeutic effectiveness is the same, even though the FDA may not explicitly declare it as so. I will consult my physician and current pharmacist (local, non-chain pharmacy with excellent focus on patient care) to determine if I have any misunderstandings.
I have also trained the people most likely to administer epinephrine to myself (family, friends, coworkers) the particular procedures of Adrenaclick administration, so I am not too worried about procedural differences between EpiPens and my generic auto-injector.
Still, I am left wondering what the therapeutic difference between an EpiPen and a generic Adrenaclick alternative really is. I do understand that different administration procedures are a problem for training, but I would expect the actual therapeutic effects of both auto-injectors to be similar --- if used administered according to directions.
[0]: http://www.pharmacytimes.com/p2p/p2pepinephrine-0910
They're not equivalent (that is, it can't be freely substituted by a dispenser) only because the devices are mechanically different. Knowing how to use an EpiPen doesn't mean knowing how to use an Adrenaclick, even if they are aministering the same drug in the same dose using more-or-less the same kind of mechanism. It's that "more-or-less" that's the key; since they differ in the way they're used and administration is quite time-sensitive, you can't assume that a person trained to use an EpiPen will be able to use an Adrenaclick properly when the time comes (or vice versa).
The epi pen wasn't extremely expensive until recently, so competitors had to take a different and riskier angle to make it in the market. Perhaps now a carbon copy will do well.
They have, the products weren't up to snuff and were recalled.
Patent on the injection system I believe
The petition to Congress mentioned in the article:
http://www.petition2congress.com/20720/stop-epipen-price-gou...
http://www.petition2congress.com/20720/stop-epipen-price-gou...
They don't produce EpiPen's as a generic in India because the Indian medical community does not recommend self-administration of epinephrine.
If you're that much in need though, you can buy pre-filled epinephrine syringes for intramuscular injection - just keep in mind the ease-of-use of an EpiPen won't be available. You have to take the time to take off the cap, insert and inject the medicine.
If you're that much in need though, you can buy pre-filled epinephrine syringes for intramuscular injection - just keep in mind the ease-of-use of an EpiPen won't be available. You have to take the time to take off the cap, insert and inject the medicine.
what happens if someone goes into anaphylaxis?
I assume they intramuscularly inject epinephrine just as you would with an EpiPen. I doubt it'd be hard for patients to get hold of an epinephrine kit.
You'll also find developing countries have far less allergic population. It's said this is partly due to urban environments having more vitamin D deficiency as well as people being more exposed to more pathogens/etc during childhood outside of developed countries.
You'll also find developing countries have far less allergic population. It's said this is partly due to urban environments having more vitamin D deficiency as well as people being more exposed to more pathogens/etc during childhood outside of developed countries.
Since Sanofi previously had an equivalent product on the market for at least 3 years (called Auvi-Q), I'm really curious - why were people paying up for an Epi-pen? Was it the brand name? Do schools mandate it's an Epi-pen?
I know Sanofi pulled the product in October of last year, but it seems like Mylan has been raising prices during that time.
They seem to have some manufacturing trouble, leading to a recall[0] and pulling the product from the market. They mention Epi-Pen and Adrenaclick[1] as alternatives.
[0]https://www.auvi-q.com/recall-faqs [1]http://www.goodrx.com/adrenaclick
[0]https://www.auvi-q.com/recall-faqs [1]http://www.goodrx.com/adrenaclick
This is a simple example of how health care systems should be nationalized. Or that the profit motive in health care is corrosive to health.
No it doesn't. Switzerland has one of the best healthcare systems in the world, which is completely private (although there are some public hospitals), but heavily regulated.
Alas, there are significant differences between the Swiss and US one. Most importantly, law in Switzerland specifies exact coverage criteria for basic health insurance and prohibits excluding pre-existing conditions from it. I'm not sure how financing of hospitals works exactly (I was under the impression that they are at least partially publicly owned). Minor things: there are phone-a-doctor public services that are free of charge for residents in some areas.
Edit: also, every company that provides basic insurance can vary the price based on a limited set of factors and must accept any person.
Edit: also, every company that provides basic insurance can vary the price based on a limited set of factors and must accept any person.
The ACA standardized basic health insurance and prohibited excluding pre-existing conditions.
Heavily regulated to avoid the corrosive effect of the profit motive?
You two might actually agree.
You two might actually agree.
On that yes, in some industries a race to the bottom or winner-takes-it-all is actually bad for society, healthcare is one example.
My issue is not with the "profit" part, but the "health care systems should be nationalized" part.
My issue is not with the "profit" part, but the "health care systems should be nationalized" part.
The profit motive could also argue that the best most advanced medicine in the world is found in the US for the same reason. You just have to be able to afford it. Corrosive to who?
We have VERY GOOD medicine in the US, for anyone who can pay. It's not corrosive to 'The System'
That said: I wish I could afford a bit more healthcare
We have VERY GOOD medicine in the US, for anyone who can pay. It's not corrosive to 'The System'
That said: I wish I could afford a bit more healthcare
Is this only in the US?
I'm in Switzerland, and I bought some for my kid, I paid around 80$ per piece.
http://compendium.ch/mpro/mnr/22294/html/fr
You have the price at the far bottom of the page, around 76CHF.
I'm a bit concerned if the price is going to be x10.
I'm in Switzerland, and I bought some for my kid, I paid around 80$ per piece.
http://compendium.ch/mpro/mnr/22294/html/fr
You have the price at the far bottom of the page, around 76CHF.
I'm a bit concerned if the price is going to be x10.
I'm not familiar with the swiss health care system, but in Norway the government foots most of the bill for prescription drugs. The government is negotiating price with the manufacturer and as a big buyer they can get a fair price.
I have an EpiPen, just in case, because I keep bees. It is a prescription drug, but government co-pay doesn't kick in because the price is to low. I paid USD120, around DKK800, for one EpiPen.
My guess is that the US prices are higher, because insurance will pick up the bill for most people, allowing the manufacturer rise the prices with little consequence... for most people. Generally speaking Americans tend to pay a high cost for their lack of a national healthcare system, with very little benefit.
My guess is that the US prices are higher, because insurance will pick up the bill for most people, allowing the manufacturer rise the prices with little consequence... for most people. Generally speaking Americans tend to pay a high cost for their lack of a national healthcare system, with very little benefit.
[deleted]
This is one of those devices that also should be low cost because businesses, locations, ect should have them as well as individuals (many people can have first time deadly allergic reactions, including as adults)
That the price for the case is expensive just rose as random is serious business. There really is no need for it to be so expensive
That the price for the case is expensive just rose as random is serious business. There really is no need for it to be so expensive
I have no evidence, but this headline coupled with the insulin price hike... it really feels like this is an attempt to manufacture a crisis.
I fill a prescription for epi-pens once a year (nut allergies), but insurance bears the brunt of the cost.
I fill a prescription for epi-pens once a year (nut allergies), but insurance bears the brunt of the cost.
Insurance simply distributes the high cost to many people via higher premiums. Without competition to reduce the cost or regulations that set the price by law, the high cost remains.
>or regulations that set the price by law, the high cost remains
It is important to note that even such a law does not magically remove the high cost. Certain products have a high price for a reason and setting the price by fiat is guaranteed to cause shortages. That's when people really start dying. See Venezuela for a prime current example.
It is important to note that even such a law does not magically remove the high cost. Certain products have a high price for a reason and setting the price by fiat is guaranteed to cause shortages. That's when people really start dying. See Venezuela for a prime current example.
This is a very important point! If the fiat price is below the market price, then you are correct, shortages (or simply no product at all) are the result. If it is above the market price then the surplus is captured by the seller rather than retained by the buyer.
There is no supply side reason for the high price Mylan is charging for EpiPens. It is a couple bucks worth of materials (plus QA, distribution, and all that). The R&D costs have long since been amortized away to nothing.
How do you know? The medical industry regularly has shortages of dozens of different products [1]. And that is to say nothing of the cost of navigating through all the regulatory hurdles.
[1] http://www.economicpolicyjournal.com/2015/10/drug-shortages-...
[1] http://www.economicpolicyjournal.com/2015/10/drug-shortages-...
The price of epinephrine in other packaging (vials, ampules, etc) has remained more or less unchanged (speaking from firsthand experience as someone who orders supplies for an ambulance service). It is not an epinephrine shortage driving this price increase.
Similarly, the EpiPen is already an FDA approved product, and has had no new regulatory hurdles to jump through recently.
Similarly, the EpiPen is already an FDA approved product, and has had no new regulatory hurdles to jump through recently.
What would be the layman-evaluatable criteria for using it on a person with no history of allergy?
A friend of mine has a child with an allergy and was visiting Turkey. A family member of his (in Turkey) is a physician, and said that in Turkey nobody uses epi pens and allergies are generally never the cause of visits to the ER.
Is this true? What's going on?
Is this true? What's going on?
[deleted]
Oy. As someone who carries two of those damn things (grumble grumble Peanut allergy grumble grumble) and is a very conservative eater, this is not good.
Luckily, I haven't had to use one of them in like 8 months.
Luckily, I haven't had to use one of them in like 8 months.
This seems less damming to me considering the medicine naturally occurs inside your body. What reason is there that nobody else can make a competing product for cheaper?
I think the naturally occurring part is irrelevant. I mean it's not plutonium. Lots of interesting and unknown things are right under our noses, I don't believe that should change the value of them.
The rest of your question is great, but it's a legal one, I'm no help there...
The rest of your question is great, but it's a legal one, I'm no help there...
Regulatory hurdles to get a new device approved.
Maybe regulation is not so good after all
There was a competitor but it wasn't able to reliably inject the correct amount of medicine so it was recalled. [0]
[0] http://www.fiercepharma.com/marketing/sanofi-s-auvi-q-recall...
[0] http://www.fiercepharma.com/marketing/sanofi-s-auvi-q-recall...
The drug patent has long expired. It is an autoinjection mechanism that is patented. There have been many competitors in the market but some got recalled due to flaws.
link to patent:
https://www.google.com/patents/US20050273054
https://www.google.com/patents/US20050273054
Well you know, they need to recoup the R&D costs to develop the drug.
> Mylan, the pharmaceutical company, acquired the decades-old product in 2007, when pharmacies paid less than $100 for a two-pen set
Oh.
This is why US health care is broken people.
> Mylan, the pharmaceutical company, acquired the decades-old product in 2007, when pharmacies paid less than $100 for a two-pen set
Oh.
This is why US health care is broken people.
This is one reason. Another reason is that a huge chunk of the population will simply not see these costs.
For instance, I choose to be on a high deductible plan at my work (they offer both a high deductible plan and a traditional PPO). My wife has the choice of a reasonably priced HMO and a extremely expensive PPO.
On my high deductible plan if I need a refill for an epipen I pay the full boat unless I'm past my deductible (or really my HSA does) on my wifes HMO plan we pay $25 every time we need one. We both have prescriptions, what is the rational decision for my family to make if we need a new epipen?
That cost differences is not "free money", it comes out of the pocket of my wife's employer and peers rather than my employer and peers. There is a dramatic agency problem in the US health system as well.
For instance, I choose to be on a high deductible plan at my work (they offer both a high deductible plan and a traditional PPO). My wife has the choice of a reasonably priced HMO and a extremely expensive PPO.
On my high deductible plan if I need a refill for an epipen I pay the full boat unless I'm past my deductible (or really my HSA does) on my wifes HMO plan we pay $25 every time we need one. We both have prescriptions, what is the rational decision for my family to make if we need a new epipen?
That cost differences is not "free money", it comes out of the pocket of my wife's employer and peers rather than my employer and peers. There is a dramatic agency problem in the US health system as well.
Apparently they'll cover your copay.
https://www.epipen.com/en/copay-offer
(I didn't read it closely, but the eligibility criteria seem to be 'private insurance')
https://www.epipen.com/en/copay-offer
(I didn't read it closely, but the eligibility criteria seem to be 'private insurance')
I don't have a copay on epipens, but I do have a deductible. This actually can help me but the max is $100 off of full price (a few years ago I got $75 off with a similar card).
Oh, I didn't think you would be terribly concerned about the savings, I thought the company helping patients use their insurance was a nice addendum to your comment about the agency problem.
Edit: The way I read it, if you give the card to the pharmacy, the company will pay the $25 on your wife's plan.
Edit: The way I read it, if you give the card to the pharmacy, the company will pay the $25 on your wife's plan.
Yeah, for sure. It is interesting. Also copays vs deductible etc all seem to be ways to complicate coverage on purpose.
[deleted]
> selling service contracts, [...] The price is still $0 and there are still no regulations on it.
I assume at this point that you're being paid to shill some political viewpoint on the internet, because you just explained that the price of software isn't actually zero, because it's unusable (to the customers that buy a service contract) without a service contract, and creating a company that employs the developers that wrote the software to support that software has a high barrier to entry. (because those developers are already employed)
To pick at company at random, HortonWorks. I pick on them because I recently saw an invoice. $20,000 for 16 hours of training. So by your argument, there must be some kind of regulation there, right?
I assume at this point that you're being paid to shill some political viewpoint on the internet, because you just explained that the price of software isn't actually zero, because it's unusable (to the customers that buy a service contract) without a service contract, and creating a company that employs the developers that wrote the software to support that software has a high barrier to entry. (because those developers are already employed)
To pick at company at random, HortonWorks. I pick on them because I recently saw an invoice. $20,000 for 16 hours of training. So by your argument, there must be some kind of regulation there, right?
Accusations of astroturfing or shillage without evidence are not allowed on Hacker News. An opposing view does not count as evidence.
Please also read my reply to you at https://news.ycombinator.com/item?id=12344369, because you've broken the HN guidelines badly in this thread.
We detached this subthread from https://news.ycombinator.com/item?id=12341638 and marked it off-topic.
Please also read my reply to you at https://news.ycombinator.com/item?id=12344369, because you've broken the HN guidelines badly in this thread.
We detached this subthread from https://news.ycombinator.com/item?id=12341638 and marked it off-topic.
I assume at this point that you're being paid to shill some political viewpoint on the internet, because you just explained that the price of software isn't actually zero, because it's unusable (to the customers that buy a service contract) without a service contract
Yet here I am, using self-hosted Gitlab without having paid for a service contract, to write code for Odoo without having to pay for a service contract, using Nginx as a frontend proxy without having paid for a service contract and deploying it with Ansible without having paid for a service contract, on Ubuntu without having paid for a service contract.
Sure doesn't sound unusable to me.
Yet here I am, using self-hosted Gitlab without having paid for a service contract, to write code for Odoo without having to pay for a service contract, using Nginx as a frontend proxy without having paid for a service contract and deploying it with Ansible without having paid for a service contract, on Ubuntu without having paid for a service contract.
Sure doesn't sound unusable to me.
You're making quite a vast assumption that service contracts mean the software is unusable without them. Red Hat Linux is just one counterexample.
A further vast assumption is that your arguments are so compelling that anyone not convinced must be a paid shill.
There are many software consultants who charge over $10,000/day for doing training. Many companies find them worthwhile when amortized over a roomful of engineers. Those consultants aren't suckering anyone in by giving them free software, in fact, they don't provide any software whatsoever.
A further vast assumption is that your arguments are so compelling that anyone not convinced must be a paid shill.
There are many software consultants who charge over $10,000/day for doing training. Many companies find them worthwhile when amortized over a roomful of engineers. Those consultants aren't suckering anyone in by giving them free software, in fact, they don't provide any software whatsoever.
>> it's unusable (to the customers that buy a service contract) without a service contract
> You're making quite a vast assumption that service contracts mean the software is unusable without them. Red Hat Linux is just one counterexample.
No. I'm not. I'm basing that on the tautology that consumers of "free" software who purchase expensive service contracts spend their money purchasing expensive service contracts.
Software is free in the same way that air conditioning at the mall is free, the hugs handed out by the "free hugs" guy are free, the way that the privilege of watching advertisements on TV are free. Somebody is spending time and money making this software, because they think they are going to get more out of it than they put into it (either tangibly or intangibly (except for that TempleOS guy, who does it for the voices in his head))
And this still doesn't change anything about the EpiPen. There's a consumer surplus, and the price is increased to maximize capture of consumer surplus regardless of the cost in human lives. I don't care how free software is, the price on EpiPens is going up to maximize profit.
To frame this as a simple dichotomy, would you rather live in a world where people die to maximize profit, or a world where regulation is applied to reduce human suffering and death?
> You're making quite a vast assumption that service contracts mean the software is unusable without them. Red Hat Linux is just one counterexample.
No. I'm not. I'm basing that on the tautology that consumers of "free" software who purchase expensive service contracts spend their money purchasing expensive service contracts.
Software is free in the same way that air conditioning at the mall is free, the hugs handed out by the "free hugs" guy are free, the way that the privilege of watching advertisements on TV are free. Somebody is spending time and money making this software, because they think they are going to get more out of it than they put into it (either tangibly or intangibly (except for that TempleOS guy, who does it for the voices in his head))
And this still doesn't change anything about the EpiPen. There's a consumer surplus, and the price is increased to maximize capture of consumer surplus regardless of the cost in human lives. I don't care how free software is, the price on EpiPens is going up to maximize profit.
To frame this as a simple dichotomy, would you rather live in a world where people die to maximize profit, or a world where regulation is applied to reduce human suffering and death?
> To frame this as a simple dichotomy
Except it's not so simple. Peltzman showed with statistics in "Regulation of Pharmaceutical Innovation" that the 1962 FDA amendments resulted in an increase in human suffering and death. (The 1962 amendments added "and effective" to the FDA's mandate.)
While some ineffective drugs were prevented from reaching the market, this was overshadowed by good drugs being delayed, and a sharp reduction in new drugs being developed due to huge cost increases from the regulations.
Markets are very dynamic systems, and unintended side effects always happen even with regulations that have the best of intentions.
Except it's not so simple. Peltzman showed with statistics in "Regulation of Pharmaceutical Innovation" that the 1962 FDA amendments resulted in an increase in human suffering and death. (The 1962 amendments added "and effective" to the FDA's mandate.)
While some ineffective drugs were prevented from reaching the market, this was overshadowed by good drugs being delayed, and a sharp reduction in new drugs being developed due to huge cost increases from the regulations.
Markets are very dynamic systems, and unintended side effects always happen even with regulations that have the best of intentions.
> I assume at this point that you're being paid to shill some political viewpoint on the internet
I don't agree with Walter on this issue, but a cursory Google of who you're talking to should indicate how ridiculous this statement is. You are profoundly out of line and you owe him an apology. (You'd owe anyone an apology, but this is particularly silly of you.)
I don't agree with Walter on this issue, but a cursory Google of who you're talking to should indicate how ridiculous this statement is. You are profoundly out of line and you owe him an apology. (You'd owe anyone an apology, but this is particularly silly of you.)
> but a cursory Google of who you're talking to
Right, there's more than one person on the planet with that name, and surely the actual inventor of the D language has better things to do with his time than go all Liberatard on the Internet arguing economics with strangers.
Right, there's more than one person on the planet with that name, and surely the actual inventor of the D language has better things to do with his time than go all Liberatard on the Internet arguing economics with strangers.
You've been an HN user for a few years, so we won't ban you for this, but the way you've behaved in this thread is bannably offensive, so please don't do it again—to anybody.
Specifically: no accusations of shillage to score points in an argument; no name-calling; and respect toward your fellow users, please, from now on.
Specifically: no accusations of shillage to score points in an argument; no name-calling; and respect toward your fellow users, please, from now on.
The US is subsidizing the rest of the world. When Canada decrees that the price of something will by X, then guess who pays?
Do these things actually cost more than $100 to manufacture? The US isn't subsidizing the rest of the world with this, we're subsidizing the shareholders of a single company.
I've seen this argument made regarding American health care costs in general. Everyone else pays much less because we're subsidizing them, the argument goes. Except that American medical R&D spending is about $500/year per capita, while the gap in health care costs is thousands. That's some combination of waste and people getting rich off of other people's suffering.
This product could pretty clearly be sold at a profit at the old price. But they can make more money if they charge more. People will die because they can't afford it anymore? Fuck 'em, apparently.
I've seen this argument made regarding American health care costs in general. Everyone else pays much less because we're subsidizing them, the argument goes. Except that American medical R&D spending is about $500/year per capita, while the gap in health care costs is thousands. That's some combination of waste and people getting rich off of other people's suffering.
This product could pretty clearly be sold at a profit at the old price. But they can make more money if they charge more. People will die because they can't afford it anymore? Fuck 'em, apparently.
Indeed, the UK NHS (National Health Service) pays £26.45 per pen. NICE (the NHS purchasing and commissioning body) negotiates prices on most drugs, devices and medical services used by the NHS, and they make sure that the prices they get are not only evidence based but also sustainable (in both the fiscal and health sense).
EpiPens were created by the US government, and have been around since the 1980s. Let's not pretend they've suddenly gotten massively more expensive to make or got a burst of unprofitable popularity in Canada.
Let's not pretend that there's a properly functioning market here. The only reason for the price hike is to line pockets, not because demand fell or it suddenly became that much more expensive to produce.
A critical element of a free market is competition. Without competition you don't really have a fully functioning market mechanism at work.
So in that sense there is not a properly functioning market.
Comments in this discussion seem to fall into two categories: 1) free market has failed, lower the price via administrative fiat 2) free market doesn't exist, adjust regulations to encourage competition
One suggestion I have is to simply allow non-FDA approved devices to be sold but to be clearly labeled as not having been evaluated by the FDA. This would allow the market mechanism to put pressure on the FDA approved vendor. Re-thinking the FDA approval process is also a possibility, or even providing different types of FDA labeling (e.g., experimental, provisional, approved) based on different stages of the FDA process.
So in that sense there is not a properly functioning market.
Comments in this discussion seem to fall into two categories: 1) free market has failed, lower the price via administrative fiat 2) free market doesn't exist, adjust regulations to encourage competition
One suggestion I have is to simply allow non-FDA approved devices to be sold but to be clearly labeled as not having been evaluated by the FDA. This would allow the market mechanism to put pressure on the FDA approved vendor. Re-thinking the FDA approval process is also a possibility, or even providing different types of FDA labeling (e.g., experimental, provisional, approved) based on different stages of the FDA process.
That is likely true to some extent. The question is to what extent?
100% of the surplus accruing to pharmaceutical does not go toward research. Of the X% that does go to research, that marginal increase is likely not as effective as the budgets before the increased margin.
Also, patents shift effort from areas with low patentability prospects to areas with higher patentability prospects, even if the rate of return in terms of public health would have been substantially higher if the former opportunities were maximized first.
For that and many other reasons, the net social gain from pharmaceutical patents is contentious. Many economists have argued that the only justification is improved incentive to cover the cost of our expensive regulatory environment. Patents for almost everything else? Almost certainly a net loss.
There's little evidence that patent monopolies are needed to induce investment, generally. Don't forget that there's almost $100 trillion in liquid, investable assets floating around out there. There's more than enough capital to fund anything with even a tiny predicted profit. But individual capitalists want to maximize their returns, and monopolies often provide better margins. That good patents attract more capital is not evidence of anything; capital will first go to anything that promises higher returns relative to anything else, even if the net effect is reduced overall wealth creation for investors.
Imagine two countries with equivalently sized economies at year 1. The first is run by a dictator who will use the power of the state to extract wealth from the citizens. Part of the process involves giving sweet-heart deals to foreign investors, partly as a way to off-shore the money. For those investors the returns are 20%.
The second country is a stable democracy with low corruption. Politicians only seek foreign investment when it makes fiscal sense, and the terms only provide returns of about 10%.
In the short-term, where do you think all the capital will go to first? Over 30 years, where do you think most of the net global wealth creation will come from?
Ergo, that investors prefer investments backed by patents is proof of nothing.
That the U.S. and developed countries are leaders in research and investment also proves very little. We're also leaders in areas like consumer and industrial design, organizational management, etc, with no or minimal regulatory protection. We could be (and arguably are) leaders in technology despite protections, not because of them.
100% of the surplus accruing to pharmaceutical does not go toward research. Of the X% that does go to research, that marginal increase is likely not as effective as the budgets before the increased margin.
Also, patents shift effort from areas with low patentability prospects to areas with higher patentability prospects, even if the rate of return in terms of public health would have been substantially higher if the former opportunities were maximized first.
For that and many other reasons, the net social gain from pharmaceutical patents is contentious. Many economists have argued that the only justification is improved incentive to cover the cost of our expensive regulatory environment. Patents for almost everything else? Almost certainly a net loss.
There's little evidence that patent monopolies are needed to induce investment, generally. Don't forget that there's almost $100 trillion in liquid, investable assets floating around out there. There's more than enough capital to fund anything with even a tiny predicted profit. But individual capitalists want to maximize their returns, and monopolies often provide better margins. That good patents attract more capital is not evidence of anything; capital will first go to anything that promises higher returns relative to anything else, even if the net effect is reduced overall wealth creation for investors.
Imagine two countries with equivalently sized economies at year 1. The first is run by a dictator who will use the power of the state to extract wealth from the citizens. Part of the process involves giving sweet-heart deals to foreign investors, partly as a way to off-shore the money. For those investors the returns are 20%.
The second country is a stable democracy with low corruption. Politicians only seek foreign investment when it makes fiscal sense, and the terms only provide returns of about 10%.
In the short-term, where do you think all the capital will go to first? Over 30 years, where do you think most of the net global wealth creation will come from?
Ergo, that investors prefer investments backed by patents is proof of nothing.
That the U.S. and developed countries are leaders in research and investment also proves very little. We're also leaders in areas like consumer and industrial design, organizational management, etc, with no or minimal regulatory protection. We could be (and arguably are) leaders in technology despite protections, not because of them.
We, the people of Canada, with our taxes.
For example, an EpiPen costs $79 US ($99 AUD) in Australia.
That's about what it cost in the US until recently. It's a decades-old generic med, the patent on the delivery device is long expired (https://www.google.com/patents/US4031893), and the original research was even done by the US military.
so how is this insurance company getting away with what they're doing? you'd think someone else would produce it, sell it for <$100, and people would just buy them out of pocket. what stops that?
Other companies don't sell them. They bailed for various reasons, and the expense of getting in just isn't worth it.
If you develop an EpiPen and it costs you a bunch of money then in theory you can make it up by selling more volume. Except your competitor can just cut the price because they are already selling for an absurd amount of money, so how do you win now?
Maybe we should have a non-profit that does generic versions, and we can subsidize it by preferring them to companies like this (e.g. all medicare provided drugs now go through this company which sells generics). Unless the companies are willing to match prices.
If you develop an EpiPen and it costs you a bunch of money then in theory you can make it up by selling more volume. Except your competitor can just cut the price because they are already selling for an absurd amount of money, so how do you win now?
Maybe we should have a non-profit that does generic versions, and we can subsidize it by preferring them to companies like this (e.g. all medicare provided drugs now go through this company which sells generics). Unless the companies are willing to match prices.
> so how is this insurance company getting away with what they're doing?
It's not the insurance company, it's the drug company. The insurance companies are probably livid about the extra costs they're having to cover.
The answer to "how" is a variety of different techniques, including changing the formulation slightly (http://www.nytimes.com/2014/09/16/business/new-york-files-an...) and outright bribery of competitors (https://www.washingtonpost.com/opinions/pay-to-delay-pharmac...).
It's not the insurance company, it's the drug company. The insurance companies are probably livid about the extra costs they're having to cover.
The answer to "how" is a variety of different techniques, including changing the formulation slightly (http://www.nytimes.com/2014/09/16/business/new-york-files-an...) and outright bribery of competitors (https://www.washingtonpost.com/opinions/pay-to-delay-pharmac...).
yup, and in this case and many others, it is only the insurance companies that will save the populous at large. Only they have the negotiating power to encourage competition and affect the laws regarding these devices
As others have said it's the drug company itself, not an insurance company. The patent they had on the injector has expired so others have tried and failed to bring alternatives to market. Unlike drugs, each medical device has to be vetted by the FDA. Generic drugs can get quicker to market just by showing that they're equivalent to the already approved drug. Devices can't do that.
One of the alternatives was potentially better as they had additional features, but there were problems with the injector itself and it was recalled. That's what other companies have to contend with. It's bad if the injector fails to deliver the dosage and a person dies.
So, people making a 3D printed alternative can't really ensure that the injector works reliably without a lot of work.
One of the alternatives was potentially better as they had additional features, but there were problems with the injector itself and it was recalled. That's what other companies have to contend with. It's bad if the injector fails to deliver the dosage and a person dies.
So, people making a 3D printed alternative can't really ensure that the injector works reliably without a lot of work.
> Unlike drugs, each medical device has to be vetted by the FDA. Generic drugs can get quicker to market just by showing that they're equivalent to the already approved drug. Devices can't do that.
That is incorrect -- devices can do that. Devices shown to be equivalent to an existing device can be put on the market with minimal regulatory overhead. The form to submit to the FDA for an equivalent device is a 510k Premarket Notification. Details are here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
This is what an acceptance letter from the FDA looks like for a substantially equivalent device:
http://www.texasbiogene.com/upload/content/file/TBGFDAapprov...
That is incorrect -- devices can do that. Devices shown to be equivalent to an existing device can be put on the market with minimal regulatory overhead. The form to submit to the FDA for an equivalent device is a 510k Premarket Notification. Details are here:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
This is what an acceptance letter from the FDA looks like for a substantially equivalent device:
http://www.texasbiogene.com/upload/content/file/TBGFDAapprov...
These are $125 for two pens or thereabouts in the UK, same device. Presumably import is regulated?
https://onlinedoctor.lloydspharmacy.com/uk/allergy/epipen
https://onlinedoctor.lloydspharmacy.com/uk/allergy/epipen
Actually the NHS pays £26.45 per pen.[0]
And yes it is regulated; it is considered both a drug and a medical device.
[0] https://www.evidence.nhs.uk/formulary/bnf/current/3-respirat...
And yes it is regulated; it is considered both a drug and a medical device.
[0] https://www.evidence.nhs.uk/formulary/bnf/current/3-respirat...
Some discussions:
https://www.reddit.com/r/news/comments/4y5481/cost_of_epipen...
https://www.reddit.com/r/3Dprinting/comments/4y7f26/epipen_f...