EpiPen Price Rise Sparks Concern for Allergy Sufferers
well.blogs.nytimes.com
well.blogs.nytimes.com
Some discussions:
https://www.reddit.com/r/news/comments/4y5481/cost_of_epipen...
https://www.reddit.com/r/3Dprinting/comments/4y7f26/epipen_f...
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: Alternatively, a "better" temporary solution would be to arrange for the import of these from Canada, where the price is fixed by the government.
It turns out when you have millions of people dealing together as a block, they have much more bargaining power.
Thank you Canada.
http://pmprb-cepmb.gc.ca/about-us/frequently-asked-questions
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.
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).
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).
What probabilities are you assigning to needing the printed epipen to survive, and to it functioning correctly, such that it's worth that risk?
Oh and it's probably a little hard to handle a bottle and syringe on yourself while you're suffocating.
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.
There's a pretty fair chance that you driving your living father home from the emergency room is evidence of the injection working.
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.
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'.
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.
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.
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?
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.
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.
Regulation didn't give people more money to spend on medicine. Offshoring jobs to China drive down prices of consumer goods to make more money available as a consumer surplus that could be captured by healthcare.
If the price of food increased, the price of housing, education, and medical care would decrease. Because the demand curve would change.
> A small competitor would have the capability to ruin your business with a small investment on their part. I bet they could finance it by shorting your stock.
That's a nice hypothetical that completely ignores all of financial theory AND history. If you ever start a company, let me know so I can short YOUR stock.
Why wouldn't it be captured by farmers? or carmakers?
> all of financial theory AND history
Can you give case history of a company that maintained a monopoly via periodic dumping to bankrupt any competitors? I'm not aware of one, and no, Standard Oil is not one (see the book "Titan" about it). I've read many econ/history books, and none them put forward your dumping theory. Do you have a book reading list?
The other one is the enactment of Medicare/Medicaid in 1966/1965. From the graphs I've seen, that corresponded with the knee in the curve.
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.
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.
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.
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.
>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.
Of course, I'm not providing any citations myself!
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.
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.
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.
How does that help your case? The members of that organization are governments, not companies. OPEC is regulation.
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.
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...
[1] Blame is justifiably attributed to the government whether you believe the fix is a freer market (to reduce the costs associated with bringing suitable competitors to market) or you believe regulation should prevent this from happening. Apart from the requirements codified into law, we should have no expectation of altruism by companies, especially when their existence is intrinsically related to profit-seeking motives.
(1) seems like a total cop-out to me. By that logic, you can blame everything on the government. Some guy murders his family in a fit of rage? Government should have done a better job preventing it.
Also, part of the point of this kind of outrage is to punish these companies for their behavior so that the evil choice is not the most profitable one.
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 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.
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.
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.
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.
The only way to get any legislative action on this is to get the electorate to care about it so that legislators get convinced that they need to act on this in order to keep their constituency returning to the polls and checking off their name.
And in order to do that, you need to talk about how problematic and reprehensible these moves are, so people actually care about it.
So really, both the social shaming and legislative approaches start out the same way. Unless you think you're talking to a dictator, your "stop whining and pass some laws" approach is nonsensical.
> And in order to do that, you need to talk about how problematic and reprehensible these moves are, so people actually care about it.
It sounds like we're in agreement there. The only difference is, you've expressed an unrealistic expectation with regard to the effectiveness of social pressure directly aimed at the company involved. If history is any guide, we can only expect systemic improvement in this scenario through legislation and/or deregulation. Otherwise, you're merely treating symptoms of the problem, not the cause (and no, the cause isn't capitalism or profit-seeking companies as many may have you believe).
Now, if trying to fix problems in our country through the use of a system of rules and regulations (aka, laws) that has been established for that very purpose is nonsensical, then so be it. I suppose that view is indeed nonsensical in the context of today's prevailing social attitudes.
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.
Sure, we mostly stopped doing this for various stupid reasons, but legally it's sill an option.
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.
- 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.
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.
There really isn't any good answer to this, and there will be losers in either scenario.
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.
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."
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.
What makes you think the FDA doesn't require this?
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.
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...
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.
Other than that, they could be 3-d printed or whatever is cheapest by many providers
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.
Yes, this is sub-optimal in a life or death situation, but it's a reasonable counter to unreasonably high EpiPen pricing. Moreover, if this becomes common practice or if it's even feared as plausible, it could help reduce EpiPen pricing.
I think that rules it out. Imagine a family member, or anyone, dying because of your sub-optimal solution.
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.
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?
Yes?
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
https://www.evidence.nhs.uk/formulary/bnfc/current/3-respira...
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
Looking at direct and indirect costs insurance adds ~20+% to healthcare spending. Remember insurance commercials for example are yet another cost.
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...
What does the NHS do about drugs that are sole source?
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.
http://www.nytimes.com/2013/10/13/us/the-soaring-cost-of-a-s...
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.
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.
Are there patents involved?
I can't see why any protection is necessary.
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 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.
> 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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.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 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.
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.
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.
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.
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.
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.
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'
It's a racket.
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...
New York State is actually in the process of transitioning EMTs from EpiPens to vial/syringe kits.
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.
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!
Looks like the differences are: extra safety cap and Epipen brand has an auto-retracting needle.
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.
What would be morally justified, to stop it?
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.
A free market would mean anyone who wanted to to create one of these.
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.
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).
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?
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.
> 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.
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.
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.
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.
"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.
But you can't, can you? Is that because of free market worship, or worship of the regulatory state?
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.
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'.
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...
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.
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...
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-...
It is a well known hack taught in wilderness medicine training.
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.
Also, I would hardly call a link to YouTube "a mystery link to a random place on the web".
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.
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.
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
Something seems to be missing from this article.
Courtesy ceejayoz below: https://news.ycombinator.com/item?id=12340464
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!
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?
Cut out the private market and have the government manufacture it directly.
it is primarily to avoid redundancies
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.
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.
[1] http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
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.
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-...
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...
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.
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.
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.
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.
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 $1 syringe can save a life. It is offensive that the FDA thinks it should get in the way of the distribution of such things.
I was in Colorado last summer and took my son horseback riding. Our tour guide was allergic to bee stings, but she was just scraping by financially, and couldn't afford an Epipen. She'd been stung before, and her throat had tightened, but fortunately she happened to have an old, expired pen from before the price went up and so she survived. But now she was going out bare. We gave her one my son's pens. It won't last long. It's possible that she won't last long either.
You want evidence this is an evil system? There it is.
Do you really believe the FDA isn't doing this? The price of these drugs is directly linked with the risk*cost of being sued. In order to reduce the cost of the drugs, we need to reduce the benefits of suing, but this will undoubtably upset libertarians. Can't please everyone.
Generally, prices are set to whatever will maximize profit. In the 'free market', nobody with any sophistication prices things based on cost. It's a fundamental of microeconomics.
IMO, I also don't see how your solution would solve any real problems. People shouldn't have to ask themselves "Do I buy the one that is 600$ 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?"
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.
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.
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.
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.
They can't win!
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.
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.
http://www.petition2congress.com/20720/stop-epipen-price-gou...
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.
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.
[0]https://www.auvi-q.com/recall-faqs [1]http://www.goodrx.com/adrenaclick
You two might actually agree.
My issue is not with the "profit" part, but the "health care systems should be nationalized" part.
Edit: also, every company that provides basic insurance can vary the price based on a limited set of factors and must accept any person.
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
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.
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.
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 fill a prescription for epi-pens once a year (nut allergies), but insurance bears the brunt of the cost.
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.
[1] http://www.economicpolicyjournal.com/2015/10/drug-shortages-...
Similarly, the EpiPen is already an FDA approved product, and has had no new regulatory hurdles to jump through recently.
Is this true? What's going on?
Luckily, I haven't had to use one of them in like 8 months.
[0] http://www.fiercepharma.com/marketing/sanofi-s-auvi-q-recall...
The rest of your question is great, but it's a legal one, I'm no help there...
> 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.
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.
https://www.epipen.com/en/copay-offer
(I didn't read it closely, but the eligibility criteria seem to be 'private insurance')
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.
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?
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.
> 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?
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 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.)
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.
Specifically: no accusations of shillage to score points in an argument; no name-calling; and respect toward your fellow users, please, from now on.
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.
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.
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.
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...).
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.
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...
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.
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.
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.
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...